Trial Outcomes & Findings for P53 Mutational Status and cf HPV DNA for the Management of HPV-associated OPSCC (NCT NCT03077243)
NCT ID: NCT03077243
Last Updated: 2024-05-02
Results Overview
PFS was assessed as the time from the first day of chemoradiation therapy (CRT) until disease progression. Disease progression was defined as biopsy proven tumor cells. Positron emission tomography / computerized tomography (PET/CT) was performed at week 10-16 (optimally at week 12) after completion of therapy. Biopsies were performed for subjects with imaging or clinical exam results suspicious for tumor. Clinical follow-up occurred and chest imaging was performed during the follow-up.
COMPLETED
PHASE2
195 participants
Two years after completion of the treatment
2024-05-02
Participant Flow
Participants were recruited from 08/25/2016 through 12/11/2020 at 4 cancer centers in the United States.
A total of 195 subjects consented and started the study. Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. The validity of existing, sequestered data from sites 3 and 4 cannot be confirmed and may not be reliable. Therefore, arm/group and follow-up data related to sixty-nine subjects are not included and 126 subjects with arm/group and follow-up were presented.
Participant milestones
| Measure |
Group A
Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy.
|
Group B
Subjects with oropharyngeal squamous cell carcinoma have equal to or less than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy
|
Group C
Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history and with the p53 mutation and/or treating physicians' discretion receiving 70Gy radiotherapy with or without chemotherapy.
|
Group DataUnknown
Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. Demographic data and site assignment for all subjects were stored centrally. Therefore, arm/group and follow-up data related to sixty-nine subjects are missing.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
105
|
3
|
69
|
|
Overall Study
Assessment and Biopsy Was Done if Required at 2 Years After Treatment
|
11
|
51
|
2
|
0
|
|
Overall Study
COMPLETED
|
15
|
100
|
3
|
0
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
0
|
69
|
Reasons for withdrawal
| Measure |
Group A
Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy.
|
Group B
Subjects with oropharyngeal squamous cell carcinoma have equal to or less than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy
|
Group C
Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history and with the p53 mutation and/or treating physicians' discretion receiving 70Gy radiotherapy with or without chemotherapy.
|
Group DataUnknown
Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. Demographic data and site assignment for all subjects were stored centrally. Therefore, arm/group and follow-up data related to sixty-nine subjects are missing.
|
|---|---|---|---|---|
|
Overall Study
Death
|
1
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
0
|
0
|
|
Overall Study
Physician Decision
|
1
|
0
|
0
|
0
|
|
Overall Study
Research at two study sites terminated early
|
0
|
0
|
0
|
69
|
Baseline Characteristics
P53 Mutational Status and cf HPV DNA for the Management of HPV-associated OPSCC
Baseline characteristics by cohort
| Measure |
Group A
n=18 Participants
Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy.
|
Group B
n=105 Participants
Subjects with oropharyngeal squamous cell carcinoma have equal to or less than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy.
|
Group C
n=3 Participants
Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history and with the p53 mutation and/or treating physicians' discretion receiving 70Gy radiotherapy with or without chemotherapy.
|
Group Data Unknown
n=69 Participants
Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. Demographic data and site assignment for all subjects were stored centrally. Therefore, arm/group and follow-up data related to sixty-nine subjects are missing.
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
62.72 years
STANDARD_DEVIATION 8.43 • n=39 Participants
|
59.89 years
STANDARD_DEVIATION 9.8 • n=41 Participants
|
61.66 years
STANDARD_DEVIATION 4.16 • n=35 Participants
|
64.5 years
STANDARD_DEVIATION 9.74 • n=31 Participants
|
60.86 years
STANDARD_DEVIATION 9.61 • n=146 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=39 Participants
|
12 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
3 Participants
n=31 Participants
|
19 Participants
n=146 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=39 Participants
|
93 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
66 Participants
n=31 Participants
|
176 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
5 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=39 Participants
|
99 Participants
n=41 Participants
|
3 Participants
n=35 Participants
|
67 Participants
n=31 Participants
|
185 Participants
n=146 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=39 Participants
|
3 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
5 Participants
n=146 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
1 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=39 Participants
|
4 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
2 Participants
n=31 Participants
|
7 Participants
n=146 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=39 Participants
|
91 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
67 Participants
n=31 Participants
|
177 Participants
n=146 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=146 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
10 Participants
n=146 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=39 Participants
|
105 participants
n=41 Participants
|
3 participants
n=35 Participants
|
69 participants
n=31 Participants
|
195 participants
n=146 Participants
|
PRIMARY outcome
Timeframe: Two years after completion of the treatmentPopulation: Subjects completed the study procedures including treatment, PET/CT, and biopsy when required, and followed up 2 years after completion of the treatment. Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. The validity of existing, sequestered outcome data from sites 3 and 4 cannot be confirmed and may not be reliable. Therefore, arm/group and follow-up data related to sixty-nine subjects are not included.
PFS was assessed as the time from the first day of chemoradiation therapy (CRT) until disease progression. Disease progression was defined as biopsy proven tumor cells. Positron emission tomography / computerized tomography (PET/CT) was performed at week 10-16 (optimally at week 12) after completion of therapy. Biopsies were performed for subjects with imaging or clinical exam results suspicious for tumor. Clinical follow-up occurred and chest imaging was performed during the follow-up.
Outcome measures
| Measure |
Group A
n=11 Participants
Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy.
|
Group B
n=51 Participants
Subjects with oropharyngeal squamous cell carcinoma have equal to or less than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy.
|
Group C
n=2 Participants
Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history and with the p53 mutation and/or treating physicians' discretion receiving 70Gy radiotherapy with or without chemotherapy.
|
|---|---|---|---|
|
Progression Free Survival (PFS)
Biopsy proven relapse was found
|
3 Participants
|
6 Participants
|
0 Participants
|
|
Progression Free Survival (PFS)
Biopsy proven relapse was not found
|
8 Participants
|
45 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: BaselinePopulation: Subjects started the treatment and provided specimens for plasma circulating free HPV DNA analysis at baseline. Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. The validity of existing, sequestered outcome data from sites 3 and 4 cannot be confirmed and may not be reliable. Therefore, arm/group and follow-up data related to sixty-nine subjects are not included.
The number of subjects who have or do not have plasma circulating free Human papillomavirus Deoxyribonucleic acid (HPV- DNA) was tabulated.
Outcome measures
| Measure |
Group A
n=14 Participants
Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy.
|
Group B
n=63 Participants
Subjects with oropharyngeal squamous cell carcinoma have equal to or less than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy.
|
Group C
n=2 Participants
Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history and with the p53 mutation and/or treating physicians' discretion receiving 70Gy radiotherapy with or without chemotherapy.
|
|---|---|---|---|
|
Number of Participants With Plasma Circulating Free DNA -Baseline
HPV (+)
|
13 Participants
|
59 Participants
|
2 Participants
|
|
Number of Participants With Plasma Circulating Free DNA -Baseline
HPV (-)
|
1 Participants
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3 months after completion of the treatmentPopulation: Subjects completed the study treatment and provided specimens for plasma circulating free HPV DNA analysis at 3 months after the completion of radiotherapy. Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. The validity of existing, sequestered outcome data from sites 3 and 4 cannot be confirmed and may not be reliable. Therefore, arm/group and follow-up data related to sixty-nine subjects are not included.
The number of subjects who have or do not have plasma circulating free Human papillomavirus Deoxyribonucleic acid (HPV- DNA) was tabulated.
Outcome measures
| Measure |
Group A
n=13 Participants
Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy.
|
Group B
n=59 Participants
Subjects with oropharyngeal squamous cell carcinoma have equal to or less than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy.
|
Group C
n=1 Participants
Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history and with the p53 mutation and/or treating physicians' discretion receiving 70Gy radiotherapy with or without chemotherapy.
|
|---|---|---|---|
|
Number of Participants With Plasma Circulating Free DNA -3months
HPV (+)
|
3 Participants
|
19 Participants
|
0 Participants
|
|
Number of Participants With Plasma Circulating Free DNA -3months
HPV (-)
|
10 Participants
|
40 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 1 year after completion of the treatmentPopulation: Subjects completed the study treatment and provided specimens for plasma circulating free HPV DNA analysis 1 year after the completion of radiotherapy. Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. The validity of existing, sequestered outcome data from sites 3 and 4 cannot be confirmed and may not be reliable. Therefore, arm/group and follow-up data related to sixty-nine subjects are not included.
The number of subjects who have or do not have plasma circulating free Human papillomavirus Deoxyribonucleic acid (HPV- DNA) was tabulated.
Outcome measures
| Measure |
Group A
n=7 Participants
Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy.
|
Group B
n=51 Participants
Subjects with oropharyngeal squamous cell carcinoma have equal to or less than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy.
|
Group C
Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history and with the p53 mutation and/or treating physicians' discretion receiving 70Gy radiotherapy with or without chemotherapy.
|
|---|---|---|---|
|
Number of Participants With Plasma Circulating Free DNA -1 Year
HPV (+)
|
2 Participants
|
10 Participants
|
0 Participants
|
|
Number of Participants With Plasma Circulating Free DNA -1 Year
HPV (-)
|
5 Participants
|
41 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 2 years after completion of the treatmentPopulation: Subjects completed the study treatment and provided specimens for plasma circulating free HPV DNA analysis 2 years after the completion of radiotherapy. Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. The validity of existing, sequestered outcome data from sites 3 and 4 cannot be confirmed and may not be reliable. Therefore, arm/group and follow-up data related to sixty-nine subjects are not included.
The number of subjects who have or do not have plasma circulating free Human papillomavirus Deoxyribonucleic acid (HPV- DNA) was tabulated.
Outcome measures
| Measure |
Group A
n=6 Participants
Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy.
|
Group B
n=39 Participants
Subjects with oropharyngeal squamous cell carcinoma have equal to or less than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy.
|
Group C
n=1 Participants
Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history and with the p53 mutation and/or treating physicians' discretion receiving 70Gy radiotherapy with or without chemotherapy.
|
|---|---|---|---|
|
Number of Participants With Plasma Circulating Free DNA -2 Year
HPV (+)
|
2 Participants
|
16 Participants
|
0 Participants
|
|
Number of Participants With Plasma Circulating Free DNA -2 Year
HPV (-)
|
4 Participants
|
23 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 years after completion of the treatmentPopulation: Subjects completed the study procedures including treatment, PET/CT, and biopsy when required, and followed up 2 years after completion of the treatment. Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. The validity of existing, sequestered outcome data from sites 3 and 4 cannot be confirmed and may not be reliable. Therefore, arm/group and follow-up data related to sixty-nine subjects are not included.
The local control rate is defined as the total disappearance of the primary tumor without any local recurrence. Local recurrence was defined as biopsy-proven tumor cells in the primary tumor region. Biopsy was performed for a subject with a positive positron emission tomography / computerized tomography scan and /or clinical discretion of the surgeon 16 weeks after completion of the treatment.
Outcome measures
| Measure |
Group A
n=11 Participants
Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy.
|
Group B
n=51 Participants
Subjects with oropharyngeal squamous cell carcinoma have equal to or less than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy.
|
Group C
n=2 Participants
Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history and with the p53 mutation and/or treating physicians' discretion receiving 70Gy radiotherapy with or without chemotherapy.
|
|---|---|---|---|
|
Local Control Rate
local relapse
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Local Control Rate
No local relapse
|
11 Participants
|
51 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 2 years post-CRTPopulation: Subjects completed the study procedures including treatment, PET/CT, and biopsy when required, and followed up 2 years after completion of the treatment. Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. The validity of existing, sequestered outcome data from sites 3 and 4 cannot be confirmed and may not be reliable. Therefore, arm/group and follow-up data related to sixty-nine subjects are not included.
Regional control rate is defined as the total disease disappearance of the related lymph node metastases without any lymph node recurrence. Regional recurrence was defined as biopsy proven tumor cells in related lymph nodes. Biopsy was performed for a subject with a positive positron emission tomography / computerized tomography scan and /or clinical discretion of the surgeon 16 weeks after completion of the treatment.
Outcome measures
| Measure |
Group A
n=11 Participants
Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy.
|
Group B
n=51 Participants
Subjects with oropharyngeal squamous cell carcinoma have equal to or less than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy.
|
Group C
n=2 Participants
Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history and with the p53 mutation and/or treating physicians' discretion receiving 70Gy radiotherapy with or without chemotherapy.
|
|---|---|---|---|
|
Regional Control Rate
Biopsy proven regional relapse was found
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Regional Control Rate
Biopsy proven regional relapse was not found
|
10 Participants
|
49 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 2 years after completion of the treatmentPopulation: Subjects completed the study procedures including treatment, PET/CT, and biopsy when required, and followed up 2 years after completion of the treatment. Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. The validity of existing, sequestered outcome data from sites 3 and 4 cannot be confirmed and may not be reliable. Therefore, arm/group and follow-up data related to sixty-nine subjects are not included.
Local-regional control rate is defined as the total disappearance of the primary tumor and related lymph node metastases without any recurrence. Local-regional recurrence was defined as biopsy-proven tumor cells in the primary tumor region and/or related lymph nodes. Biopsy was performed for a subject with a positive positron emission tomography / computerized tomography scan and /or clinical discretion of the surgeon 16 weeks after completion of the treatment.
Outcome measures
| Measure |
Group A
n=11 Participants
Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy.
|
Group B
n=51 Participants
Subjects with oropharyngeal squamous cell carcinoma have equal to or less than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy.
|
Group C
n=2 Participants
Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history and with the p53 mutation and/or treating physicians' discretion receiving 70Gy radiotherapy with or without chemotherapy.
|
|---|---|---|---|
|
Local-regional Control Rate
Biopsy proven local or regional relapse was found
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Local-regional Control Rate
Biopsy proven local or regional relapse was not found
|
10 Participants
|
49 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Two years after completion of the treatmentPopulation: Subjects completed the study procedures including treatment, PET/CT, and biopsy when required, and followed up 2 years after completion of the treatment. Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. The validity of existing, sequestered outcome data from sites 3 and 4 cannot be confirmed and may not be reliable. Therefore, arm/group and follow-up data related to sixty-nine subjects are not included.
Distant metastasis-free survival is defined as the time from the first day of the study treatment to the date of disease spreads while subjects are alive. Distant metastasis-free survival is defined as no disease outside of the primary tumor and related lymph node metastases. Distant metastasis was defined as biopsy-proven tumor cells outside of the primary tumor and related lymph node metastases. Biopsy was performed for a subject with a positive positron emission tomography / computerized tomography scan and /or clinical discretion of the surgeon 16 weeks after completion of the treatment.
Outcome measures
| Measure |
Group A
n=11 Participants
Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy.
|
Group B
n=51 Participants
Subjects with oropharyngeal squamous cell carcinoma have equal to or less than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy.
|
Group C
n=2 Participants
Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history and with the p53 mutation and/or treating physicians' discretion receiving 70Gy radiotherapy with or without chemotherapy.
|
|---|---|---|---|
|
Distant Metastasis Free Survival
Biopsy proven distant metastasis was found
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Distant Metastasis Free Survival
Biopsy proven distant metastasis was not found
|
9 Participants
|
47 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 2 years after completion of treatmentPopulation: Research at two study sites terminated early. Each site collected and stored the research data for its participants in its own systems. The validity of existing, sequestered outcome data from sites 3 and 4 cannot be confirmed and may not be reliable. Therefore, arm/group and follow-up data related to sixty-nine subjects are not included.
The overall survival rate is defined as the time from the first day of the study treatment to the date of death for any cause. Subjects who have not had an event will be censored at the date of the last assessment documenting the subject was alive.
Outcome measures
| Measure |
Group A
n=12 Participants
Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy.
|
Group B
n=55 Participants
Subjects with oropharyngeal squamous cell carcinoma have equal to or less than 10 years of smoking history, without p53 mutation and receiving 60Gy radiotherapy with or without chemotherapy.
|
Group C
n=2 Participants
Subjects with oropharyngeal squamous cell carcinoma have more than 10 years of smoking history and with the p53 mutation and/or treating physicians' discretion receiving 70Gy radiotherapy with or without chemotherapy.
|
|---|---|---|---|
|
Overall Survival Rate
Death
|
1 Participants
|
4 Participants
|
0 Participants
|
|
Overall Survival Rate
Alive
|
11 Participants
|
51 Participants
|
2 Participants
|
Adverse Events
Group A
Group B
Group C
Group DataUnknown
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Melahat G. Canter MD MS Clinical Trial Analyst
University of North Carolina Lineberger Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee LCCC1612 is a multi-site study. Three of the four site investigators are not employees of the Sponsor. Restrictions to disclosure do not apply due to circumstances of non-compliance. Study data was sequestered, data is not accessible for further analysis or publication.
- Publication restrictions are in place
Restriction type: OTHER