Trial Outcomes & Findings for A Single-arm Phase II Study of Post-Transoral Robotic Surgery (TORS) Alone to the Primary Tumor Site and Selective Neck Dissection (SND) Followed by Adjuvant Radiation Therapy (+/- Chemotherapy) to the Regional Nodes for Advanced Stage, Human Papilloma Virus (HPV) Positive, Oropharyngeal Cancer (NCT NCT02159703)
NCT ID: NCT02159703
Last Updated: 2019-11-21
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
2 years
Results posted on
2019-11-21
Participant Flow
Participant milestones
| Measure |
Single Arm Phase 2
Post-Transoral Robotic Surgery (TORS) Alone to the Primary Tumor Site and Selective Neck Dissection (SND) Followed by Adjuvant Radiation Therapy (+/- Chemotherapy)
|
|---|---|
|
Overall Study
STARTED
|
60
|
|
Overall Study
COMPLETED
|
60
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Single-arm Phase II Study of Post-Transoral Robotic Surgery (TORS) Alone to the Primary Tumor Site and Selective Neck Dissection (SND) Followed by Adjuvant Radiation Therapy (+/- Chemotherapy) to the Regional Nodes for Advanced Stage, Human Papilloma Virus (HPV) Positive, Oropharyngeal Cancer
Baseline characteristics by cohort
| Measure |
Single Arm Phase 2
n=60 Participants
TORS
Adjuvant Radiation Therapy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
45 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
15 Participants
n=99 Participants
|
|
Age, Continuous
|
58.51 years
STANDARD_DEVIATION 9.83 • n=99 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
50 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
60 Participants
n=99 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
58 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 2 yearsOutcome measures
| Measure |
Single Arm Phase 2
n=60 Participants
TORS
Adjuvant Radiation Therapy
|
|---|---|
|
Percentage of Participants With Local Control
|
97.9 percentage of patients
Interval 86.1 to 99.7
|
Adverse Events
Single Arm Phase 2
Serious events: 18 serious events
Other events: 43 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Single Arm Phase 2
n=60 participants at risk
TORS
Adjuvant Radiation Therapy
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Injury, poisoning and procedural complications
Dermatitis radiation
|
13.3%
8/60 • Number of events 8 • 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Esophageal pain
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Other Gastrointestinal disorders
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
5.0%
3/60 • Number of events 3 • 2 years
|
Other adverse events
| Measure |
Single Arm Phase 2
n=60 participants at risk
TORS
Adjuvant Radiation Therapy
|
|---|---|
|
Skin and subcutaneous tissue disorders
Alopecia
|
30.0%
18/60 • Number of events 18 • 2 years
|
|
Metabolism and nutrition disorders
Anorexia
|
31.7%
19/60 • Number of events 28 • 2 years
|
|
Psychiatric disorders
Anxiety
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
6.7%
4/60 • Number of events 5 • 2 years
|
|
Gastrointestinal disorders
Constipation
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
3/60 • Number of events 3 • 2 years
|
|
Psychiatric disorders
Depression
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Injury, poisoning and procedural complications
Dermatitits radiation
|
65.0%
39/60 • Number of events 79 • 2 years
|
|
Nervous system disorders
Dizziness
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Dry Mouth
|
55.0%
33/60 • Number of events 44 • 2 years
|
|
Nervous system disorders
Dysgeusia
|
66.7%
40/60 • Number of events 73 • 2 years
|
|
Gastrointestinal disorders
Dysphagia
|
38.3%
23/60 • Number of events 36 • 2 years
|
|
Ear and labyrinth disorders
Other Ear and labyrinth disorders
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
General disorders
Edema face
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Esophageal pain
|
20.0%
12/60 • Number of events 17 • 2 years
|
|
General disorders
Fatigue
|
43.3%
26/60 • Number of events 34 • 2 years
|
|
Gastrointestinal disorders
Other Gastrointestinal disorders
|
5.0%
3/60 • Number of events 3 • 2 years
|
|
General disorders
Other General disorders and administration site conditions
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
5.0%
3/60 • Number of events 3 • 2 years
|
|
Endocrine disorders
Hypothyroidism
|
6.7%
4/60 • Number of events 4 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal edema
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Lip pain
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Vascular disorders
Lymphedema
|
33.3%
20/60 • Number of events 24 • 2 years
|
|
Infections and infestations
Mucosal infection
|
18.3%
11/60 • Number of events 25 • 2 years
|
|
Gastrointestinal disorders
Mucositis oral
|
30.0%
18/60 • Number of events 24 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Other Musculoskeletal and connective tissue disorder
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Nausea
|
5.0%
3/60 • Number of events 3 • 2 years
|
|
General disorders
Neck edema
|
6.7%
4/60 • Number of events 4 • 2 years
|
|
Nervous system disorders
Other Nervous system disorders
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Gastrointestinal disorders
Oral pain
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
General disorders
Pain
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Gastrointestinal disorders
Salivary duct inflammation
|
46.7%
28/60 • Number of events 38 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
11.7%
7/60 • Number of events 7 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Superficial soft tissue fibrosis
|
18.3%
11/60 • Number of events 11 • 2 years
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
3.3%
2/60 • Number of events 2 • 2 years
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
30.0%
18/60 • Number of events 22 • 2 years
|
|
Gastrointestinal disorders
Vomiting
|
1.7%
1/60 • Number of events 1 • 2 years
|
|
Investigations
Weight loss
|
5.0%
3/60 • Number of events 3 • 2 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place