Trial Outcomes & Findings for Radiation + Cisplatin or Panitumumab in Locally Advanced Stage III or Stage IV Head and Neck Cancer (NCT NCT00820248)
NCT ID: NCT00820248
Last Updated: 2023-08-22
Results Overview
The progression event is defined by first event of the following, Local-regional progression or recurrence Distant metastasis Non-protocol RT, chemotherapy, or biologic therapy without documentation of the site of failure Surgery of primary site with tumour present/unknown Neck dissection with tumour present/unknown, \> 15 weeks from end of RT Death due to study cancer or from unknown causes or any other reason Number of patients with and without progression event will be reported.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
320 participants
Primary outcome timeframe
6.2 years
Results posted on
2023-08-22
Participant Flow
Participant milestones
| Measure |
Cisplatin
Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
cisplatin: Given IV
3-dimensional conformal radiation therapy: Patients undergo radiotherapy
intensity-modulated radiation therapy: Patients undergo radiotherapy
|
Panitumumab
Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy.
panitumumab: Given IV
3-dimensional conformal radiation therapy: Patients undergo radiotherapy
accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy
intensity-modulated radiation therapy: Patients undergo radiotherapy
|
|---|---|---|
|
Overall Study
STARTED
|
160
|
160
|
|
Overall Study
Received Protocol Treatment
|
156
|
159
|
|
Overall Study
COMPLETED
|
156
|
159
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
Cisplatin
Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
cisplatin: Given IV
3-dimensional conformal radiation therapy: Patients undergo radiotherapy
intensity-modulated radiation therapy: Patients undergo radiotherapy
|
Panitumumab
Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy.
panitumumab: Given IV
3-dimensional conformal radiation therapy: Patients undergo radiotherapy
accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy
intensity-modulated radiation therapy: Patients undergo radiotherapy
|
|---|---|---|
|
Overall Study
No treated
|
4
|
1
|
Baseline Characteristics
Radiation + Cisplatin or Panitumumab in Locally Advanced Stage III or Stage IV Head and Neck Cancer
Baseline characteristics by cohort
| Measure |
Cisplatin
n=160 Participants
Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
cisplatin: Given IV
3-dimensional conformal radiation therapy: Patients undergo radiotherapy
intensity-modulated radiation therapy: Patients undergo radiotherapy
|
Panitumumab
n=160 Participants
Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy.
panitumumab: Given IV
3-dimensional conformal radiation therapy: Patients undergo radiotherapy
accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy
intensity-modulated radiation therapy: Patients undergo radiotherapy
|
Total
n=320 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.68 years
STANDARD_DEVIATION 7.50 • n=99 Participants
|
56.40 years
STANDARD_DEVIATION 7.43 • n=107 Participants
|
56.54 years
STANDARD_DEVIATION 7.46 • n=206 Participants
|
|
Sex: Female, Male
Female
|
26 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
52 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
134 Participants
n=99 Participants
|
134 Participants
n=107 Participants
|
268 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
158 Participants
n=99 Participants
|
150 Participants
n=107 Participants
|
308 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
ECOG Performance Status
0
|
111 Participants
n=99 Participants
|
115 Participants
n=107 Participants
|
226 Participants
n=206 Participants
|
|
ECOG Performance Status
1
|
49 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
94 Participants
n=206 Participants
|
|
Anatomic Location
Oral Cavity
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Anatomic Location
Oropharynx
|
132 Participants
n=99 Participants
|
127 Participants
n=107 Participants
|
259 Participants
n=206 Participants
|
|
Anatomic Location
Larynx
|
18 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
35 Participants
n=206 Participants
|
|
Anatomic Location
Hypopharynx
|
8 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
19 Participants
n=206 Participants
|
|
Smoking
No
|
47 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
91 Participants
n=206 Participants
|
|
Smoking
Yes
|
113 Participants
n=99 Participants
|
116 Participants
n=107 Participants
|
229 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6.2 yearsThe progression event is defined by first event of the following, Local-regional progression or recurrence Distant metastasis Non-protocol RT, chemotherapy, or biologic therapy without documentation of the site of failure Surgery of primary site with tumour present/unknown Neck dissection with tumour present/unknown, \> 15 weeks from end of RT Death due to study cancer or from unknown causes or any other reason Number of patients with and without progression event will be reported.
Outcome measures
| Measure |
Cisplatin
n=160 Participants
Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
cisplatin: Given IV
3-dimensional conformal radiation therapy: Patients undergo radiotherapy
intensity-modulated radiation therapy: Patients undergo radiotherapy
|
Panitumumab
n=160 Participants
Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy.
panitumumab: Given IV
3-dimensional conformal radiation therapy: Patients undergo radiotherapy
accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy
intensity-modulated radiation therapy: Patients undergo radiotherapy
|
|---|---|---|
|
Progression-free Survival (PFS) Rate
PFS event
|
50 Participants
|
43 Participants
|
|
Progression-free Survival (PFS) Rate
no PFS event
|
110 Participants
|
117 Participants
|
SECONDARY outcome
Timeframe: 6.2 yearsOverall survival is defined as the time interval between the date of randomization to date of death from any cause (calculated in months). Otherwise, survival is censored at the last date that the patient is known to be alive. Number of death and alive patients will be reported.
Outcome measures
| Measure |
Cisplatin
n=160 Participants
Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
cisplatin: Given IV
3-dimensional conformal radiation therapy: Patients undergo radiotherapy
intensity-modulated radiation therapy: Patients undergo radiotherapy
|
Panitumumab
n=160 Participants
Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy.
panitumumab: Given IV
3-dimensional conformal radiation therapy: Patients undergo radiotherapy
accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy
intensity-modulated radiation therapy: Patients undergo radiotherapy
|
|---|---|---|
|
Overall Survival Rate
Death
|
43 Participants
|
32 Participants
|
|
Overall Survival Rate
Alive
|
117 Participants
|
128 Participants
|
Adverse Events
Cisplatin
Serious events: 0 serious events
Other events: 156 other events
Deaths: 43 deaths
Panitumumab
Serious events: 0 serious events
Other events: 159 other events
Deaths: 32 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cisplatin
n=156 participants at risk
Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
cisplatin: Given IV
3-dimensional conformal radiation therapy: Patients undergo radiotherapy
intensity-modulated radiation therapy: Patients undergo radiotherapy
|
Panitumumab
n=159 participants at risk
Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy.
panitumumab: Given IV
3-dimensional conformal radiation therapy: Patients undergo radiotherapy
accelerated radiation therapy: Patients undergo accelerated fractionation radiotherapy
intensity-modulated radiation therapy: Patients undergo radiotherapy
|
|---|---|---|
|
Ear and labyrinth disorders
Hearing (monitoring program)
|
16.0%
25/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
3.1%
5/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Ear and labyrinth disorders
Hearing (without monitoring program)
|
32.1%
50/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
12.6%
20/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Ear and labyrinth disorders
Pain External ear
|
1.3%
2/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
5.0%
8/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Ear and labyrinth disorders
Pain Middle ear
|
15.4%
24/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
18.2%
29/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Ear and labyrinth disorders
Tinnitus
|
62.8%
98/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
11.3%
18/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Endocrine disorders
Hypothyroidism
|
13.5%
21/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
13.8%
22/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Eye disorders
Dry eye
|
0.00%
0/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
6.3%
10/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Gastrointestinal disorders
Chelitis
|
0.64%
1/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
6.3%
10/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Gastrointestinal disorders
Constipation
|
78.8%
123/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
71.1%
113/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Gastrointestinal disorders
Diarrhea
|
18.6%
29/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
25.2%
40/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Gastrointestinal disorders
Dry mouth
|
90.4%
141/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
91.8%
146/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Gastrointestinal disorders
Dysphagia
|
92.3%
144/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
94.3%
150/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Gastrointestinal disorders
GI - Other
|
8.3%
13/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
10.1%
16/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Gastrointestinal disorders
Heartburn
|
23.1%
36/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
30.2%
48/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Gastrointestinal disorders
Mucositis (clinical exam) Oral cavity
|
76.9%
120/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
75.5%
120/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Gastrointestinal disorders
Mucositis (functional/symptomatic) Oral cavity
|
32.7%
51/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
34.6%
55/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Gastrointestinal disorders
Nausea
|
87.2%
136/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
59.1%
94/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Gastrointestinal disorders
Pain Abdomen NOS
|
7.1%
11/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
7.5%
12/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Gastrointestinal disorders
Pain Oral cavity
|
20.5%
32/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
28.3%
45/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Gastrointestinal disorders
Salivary gland changes
|
34.6%
54/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
42.1%
67/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Gastrointestinal disorders
Teeth
|
5.1%
8/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
3.8%
6/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Gastrointestinal disorders
Vomiting
|
55.8%
87/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
39.6%
63/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
General disorders
Edema: head and neck
|
24.4%
38/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
42.1%
67/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
General disorders
Edema: limb
|
5.1%
8/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
3.8%
6/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
General disorders
Fatigue
|
79.5%
124/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
77.4%
123/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
General disorders
Fever
|
11.5%
18/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
10.7%
17/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
General disorders
Pain - Other
|
16.7%
26/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
18.2%
29/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
General disorders
Rigors/chills
|
2.6%
4/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
13.8%
22/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Infections and infestations
Infection - Other
|
28.2%
44/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
24.5%
39/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Infections and infestations
Infection with normal ANC Catheter-related
|
6.4%
10/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
5.7%
9/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Injury, poisoning and procedural complications
Dermatitis Chemoradiation
|
41.0%
64/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
50.3%
80/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Injury, poisoning and procedural complications
Dermatitis Radiation
|
60.3%
94/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
45.3%
72/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Investigations
Creatinine
|
10.9%
17/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
0.00%
0/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Investigations
Lymphopenia
|
20.5%
32/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
21.4%
34/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Investigations
Weight loss
|
87.2%
136/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
79.9%
127/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Metabolism and nutrition disorders
Anorexia
|
47.4%
74/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
43.4%
69/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Metabolism and nutrition disorders
Dehydration
|
28.8%
45/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
23.9%
38/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Musculoskeletal and connective tissue disorders
Fibrosis-deep connective tissue
|
5.8%
9/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
10.7%
17/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness Whole body/generalized
|
3.8%
6/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
6.9%
11/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
4.5%
7/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
5.7%
9/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Musculoskeletal and connective tissue disorders
Pain Back
|
5.1%
8/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
6.9%
11/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Musculoskeletal and connective tissue disorders
Pain Bone
|
4.5%
7/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
5.7%
9/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Musculoskeletal and connective tissue disorders
Pain Extremity-limb
|
5.1%
8/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
1.3%
2/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Musculoskeletal and connective tissue disorders
Pain Joint
|
5.1%
8/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
6.3%
10/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Musculoskeletal and connective tissue disorders
Pain Neck
|
12.8%
20/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
18.2%
29/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
12.8%
20/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
14.5%
23/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pain Tumor pain
|
16.0%
25/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
10.7%
17/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Nervous system disorders
Dizziness
|
12.2%
19/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
6.3%
10/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Nervous system disorders
Neuropathy-motor
|
3.2%
5/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
5.0%
8/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Nervous system disorders
Neuropathy-sensory
|
39.1%
61/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
15.1%
24/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Nervous system disorders
Pain Head/headache
|
21.2%
33/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
21.4%
34/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Nervous system disorders
Taste alteration
|
91.0%
142/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
87.4%
139/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Psychiatric disorders
Insomnia
|
32.1%
50/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
28.9%
46/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Psychiatric disorders
Mood alteration Anxiety
|
14.1%
22/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
20.1%
32/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Psychiatric disorders
Mood alteration Depression
|
7.7%
12/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
8.2%
13/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.6%
29/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
23.9%
38/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
11.5%
18/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
10.1%
16/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Edema, larynx
|
18.6%
29/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
20.1%
32/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccoughs
|
16.7%
26/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
2.5%
4/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Mucositis (clinical exam) Pharynx
|
33.3%
52/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
33.3%
53/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Pain Throat/pharynx/larynx
|
51.9%
81/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
54.1%
86/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Respiratory, thoracic and mediastinal disorders
Voice changes
|
48.7%
76/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
46.5%
74/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.64%
1/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
92.5%
147/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
34.0%
53/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
31.4%
50/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Dermatology - Other
|
4.5%
7/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
22.0%
35/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
6.4%
10/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
37.1%
59/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Hand-foot
|
0.64%
1/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
15.7%
25/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
13.5%
21/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
20.8%
33/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Hypopigmentation
|
3.8%
6/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
6.9%
11/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Induration
|
2.6%
4/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
5.7%
9/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
3.2%
5/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
11.3%
18/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Rash
|
9.6%
15/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
7.5%
12/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Sweating
|
1.3%
2/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
6.3%
10/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Skin and subcutaneous tissue disorders
Telangiectasia
|
7.7%
12/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
6.3%
10/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
|
Vascular disorders
Hypertension
|
9.0%
14/156 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
13.8%
22/159 • 6.2 years
Adverse events were collected on patients who have received the protocol treatment, which were 156 patients in Cisplatin arm and 159 patients in Panitumumab arm, as reported in the Participant Flow.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place