Trial Outcomes & Findings for Using Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission Tomography To Detect Hypoxia in Head and Neck Cancer Patients (NCT NCT00606294)
NCT ID: NCT00606294
Last Updated: 2023-06-28
Results Overview
For Cohort 1
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
216 participants
Primary outcome timeframe
4 months
Results posted on
2023-06-28
Participant Flow
Participant milestones
| Measure |
Cohort 1 (Closed to Accrual)
Cohort 1 (closed to accrual) Cohort 1 (closed to accrual) There will be no change or intervention in a patient's treatment regime using chemoradiation where both the primary and the neck nodes receive 70Gy. This is currently one accepted standard of care. In a subcohort of patients in Cohort 1 with tumors that are positive for HPV who exhibited no evidence of hypoxia on their baseline 18F-FMISO PET/ CT scan or whose tumors have early resolution of hypoxia on their repeat early response 18F-FMISO PET/CT scan will undergo an alternative treatment where the primary tumor site receives 70Gy while the neck nodes receive 60Gy followed by a planned FDG PET/CT scan and observation.
|
Cohort 2 (Closed to Accrual)
Cohort 2 (closed to accrual) Cohort 2 HPV+ tumors that demonstrate no evidence of hypoxia on an 18F-FMISO PET scan will receive 30Gy to the surgical bed and neck lymph nodes concurrent with standard chemotherapy followed by a 3-4 month post-treatment neck dissection. In patients who exhibit a complete response with this method of treatment, no further treatment is necessary. For patients within this select group who still have pathologic nodal disease, further standard chemoradiation will be given. All other patients in this cohort (i.e. those who are not in the select HPV+ tumor group outlined above) will receive standard of care treatment following their surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
197
|
19
|
|
Overall Study
COMPLETED
|
161
|
19
|
|
Overall Study
NOT COMPLETED
|
36
|
0
|
Reasons for withdrawal
| Measure |
Cohort 1 (Closed to Accrual)
Cohort 1 (closed to accrual) Cohort 1 (closed to accrual) There will be no change or intervention in a patient's treatment regime using chemoradiation where both the primary and the neck nodes receive 70Gy. This is currently one accepted standard of care. In a subcohort of patients in Cohort 1 with tumors that are positive for HPV who exhibited no evidence of hypoxia on their baseline 18F-FMISO PET/ CT scan or whose tumors have early resolution of hypoxia on their repeat early response 18F-FMISO PET/CT scan will undergo an alternative treatment where the primary tumor site receives 70Gy while the neck nodes receive 60Gy followed by a planned FDG PET/CT scan and observation.
|
Cohort 2 (Closed to Accrual)
Cohort 2 (closed to accrual) Cohort 2 HPV+ tumors that demonstrate no evidence of hypoxia on an 18F-FMISO PET scan will receive 30Gy to the surgical bed and neck lymph nodes concurrent with standard chemotherapy followed by a 3-4 month post-treatment neck dissection. In patients who exhibit a complete response with this method of treatment, no further treatment is necessary. For patients within this select group who still have pathologic nodal disease, further standard chemoradiation will be given. All other patients in this cohort (i.e. those who are not in the select HPV+ tumor group outlined above) will receive standard of care treatment following their surgery.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
36
|
0
|
Baseline Characteristics
Using Fluorine-18-Labeled Fluoro-Misonidazole Positron Emission Tomography To Detect Hypoxia in Head and Neck Cancer Patients
Baseline characteristics by cohort
| Measure |
Cohort 1 (Closed to Accrual)
n=197 Participants
Cohort 1 (closed to accrual) Cohort 1 (closed to accrual) There will be no change or intervention in a patient's treatment regime using chemoradiation where both the primary and the neck nodes receive 70Gy. This is currently one accepted standard of care. In a subcohort of patients in Cohort 1 with tumors that are positive for HPV who exhibited no evidence of hypoxia on their baseline 18F-FMISO PET/ CT scan or whose tumors have early resolution of hypoxia on their repeat early response 18F-FMISO PET/CT scan will undergo an alternative treatment where the primary tumor site receives 70Gy while the neck nodes receive 60Gy followed by a planned FDG PET/CT scan and observation.
|
Cohort 2 (Closed to Accrual)
n=19 Participants
Cohort 2 (closed to accrual) Cohort 2 HPV+ tumors that demonstrate no evidence of hypoxia on an 18F-FMISO PET scan will receive 30Gy to the surgical bed and neck lymph nodes concurrent with standard chemotherapy followed by a 3-4 month post-treatment neck dissection. In patients who exhibit a complete response with this method of treatment, no further treatment is necessary. For patients within this select group who still have pathologic nodal disease, further standard chemoradiation will be given. All other patients in this cohort (i.e. those who are not in the select HPV+ tumor group outlined above) will receive standard of care treatment following their surgery.
|
Total
n=216 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
n=5 Participants
|
57 years
n=7 Participants
|
58 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
174 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
190 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
189 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
207 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
10 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
166 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
183 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
197 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
216 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: This objective is for Cohort 1 participants.
For Cohort 1
Outcome measures
| Measure |
Cohort 1 (Closed to Accrual)
n=197 Participants
Cohort 1 (closed to accrual) Cohort 1 (closed to accrual) There will be no change or intervention in a patient's treatment regime using chemoradiation where both the primary and the neck nodes receive 70Gy. This is currently one accepted standard of care. In a subcohort of patients in Cohort 1 with tumors that are positive for HPV who exhibited no evidence of hypoxia on their baseline 18F-FMISO PET/ CT scan or whose tumors have early resolution of hypoxia on their repeat early response 18F-FMISO PET/CT scan will undergo an alternative treatment where the primary tumor site receives 70Gy while the neck nodes receive 60Gy followed by a planned FDG PET/CT scan and observation.
|
Cohort 2 (Closed to Accrual)
Cohort 2 (closed to accrual) Cohort 2 HPV+ tumors that demonstrate no evidence of hypoxia on an 18F-FMISO PET scan will receive 30Gy to the surgical bed and neck lymph nodes concurrent with standard chemotherapy followed by a 3-4 month post-treatment neck dissection. In patients who exhibit a complete response with this method of treatment, no further treatment is necessary. For patients within this select group who still have pathologic nodal disease, further standard chemoradiation will be given. All other patients in this cohort (i.e. those who are not in the select HPV+ tumor group outlined above) will receive standard of care treatment following their surgery.
|
|---|---|---|
|
To Report Positive Versus Negative Hypoxia Among Head and Neck Cancers Using 18F-FMISO Dynamic PET
Participants declined scans
|
36 Participants
|
0 Participants
|
|
To Report Positive Versus Negative Hypoxia Among Head and Neck Cancers Using 18F-FMISO Dynamic PET
Participants who are hypoxia positive
|
135 Participants
|
0 Participants
|
|
To Report Positive Versus Negative Hypoxia Among Head and Neck Cancers Using 18F-FMISO Dynamic PET
Participants who are hypoxia negative
|
26 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: This objective is for Cohort 2 participants.
For Cohort 2 - Feasibility will be determined by the pathologic response rate at time of neck dissection
Outcome measures
| Measure |
Cohort 1 (Closed to Accrual)
Cohort 1 (closed to accrual) Cohort 1 (closed to accrual) There will be no change or intervention in a patient's treatment regime using chemoradiation where both the primary and the neck nodes receive 70Gy. This is currently one accepted standard of care. In a subcohort of patients in Cohort 1 with tumors that are positive for HPV who exhibited no evidence of hypoxia on their baseline 18F-FMISO PET/ CT scan or whose tumors have early resolution of hypoxia on their repeat early response 18F-FMISO PET/CT scan will undergo an alternative treatment where the primary tumor site receives 70Gy while the neck nodes receive 60Gy followed by a planned FDG PET/CT scan and observation.
|
Cohort 2 (Closed to Accrual)
n=19 Participants
Cohort 2 (closed to accrual) Cohort 2 HPV+ tumors that demonstrate no evidence of hypoxia on an 18F-FMISO PET scan will receive 30Gy to the surgical bed and neck lymph nodes concurrent with standard chemotherapy followed by a 3-4 month post-treatment neck dissection. In patients who exhibit a complete response with this method of treatment, no further treatment is necessary. For patients within this select group who still have pathologic nodal disease, further standard chemoradiation will be given. All other patients in this cohort (i.e. those who are not in the select HPV+ tumor group outlined above) will receive standard of care treatment following their surgery.
|
|---|---|---|
|
To Determine the Pathologic Complete Response of Low Risk HPV+ Oropharyngeal Cancer Patients Without Hypoxia on 18F-FMISO PET Who Received 30Gy
Cohort 2 Pts with a Pathologic Complete Response
|
0 Participants
|
11 Participants
|
|
To Determine the Pathologic Complete Response of Low Risk HPV+ Oropharyngeal Cancer Patients Without Hypoxia on 18F-FMISO PET Who Received 30Gy
Cohort 2 Pts w/out a PathologicComplete Response
|
0 Participants
|
4 Participants
|
|
To Determine the Pathologic Complete Response of Low Risk HPV+ Oropharyngeal Cancer Patients Without Hypoxia on 18F-FMISO PET Who Received 30Gy
Cohort 2 Participants who were not scanned
|
0 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: At baselinePopulation: This objective is for Cohort 2 participants.
Cohort 2
Outcome measures
| Measure |
Cohort 1 (Closed to Accrual)
Cohort 1 (closed to accrual) Cohort 1 (closed to accrual) There will be no change or intervention in a patient's treatment regime using chemoradiation where both the primary and the neck nodes receive 70Gy. This is currently one accepted standard of care. In a subcohort of patients in Cohort 1 with tumors that are positive for HPV who exhibited no evidence of hypoxia on their baseline 18F-FMISO PET/ CT scan or whose tumors have early resolution of hypoxia on their repeat early response 18F-FMISO PET/CT scan will undergo an alternative treatment where the primary tumor site receives 70Gy while the neck nodes receive 60Gy followed by a planned FDG PET/CT scan and observation.
|
Cohort 2 (Closed to Accrual)
n=19 Participants
Cohort 2 (closed to accrual) Cohort 2 HPV+ tumors that demonstrate no evidence of hypoxia on an 18F-FMISO PET scan will receive 30Gy to the surgical bed and neck lymph nodes concurrent with standard chemotherapy followed by a 3-4 month post-treatment neck dissection. In patients who exhibit a complete response with this method of treatment, no further treatment is necessary. For patients within this select group who still have pathologic nodal disease, further standard chemoradiation will be given. All other patients in this cohort (i.e. those who are not in the select HPV+ tumor group outlined above) will receive standard of care treatment following their surgery.
|
|---|---|---|
|
Improve the Accuracy of Hypoxia Imaging for Head and Neck Cancers Through Pixel by Pixel Kinetic Analysis of 18F-FMISO Tracer of Dynamic PET Images
Cohort 2 Pts Negative at Baseline
|
0 Participants
|
6 Participants
|
|
Improve the Accuracy of Hypoxia Imaging for Head and Neck Cancers Through Pixel by Pixel Kinetic Analysis of 18F-FMISO Tracer of Dynamic PET Images
Cohort 2 Pts Positive at Baseline at Repeat Scan
|
0 Participants
|
3 Participants
|
|
Improve the Accuracy of Hypoxia Imaging for Head and Neck Cancers Through Pixel by Pixel Kinetic Analysis of 18F-FMISO Tracer of Dynamic PET Images
Cohort 2 Pts Negative at Baseline at Repeat Scan
|
0 Participants
|
9 Participants
|
|
Improve the Accuracy of Hypoxia Imaging for Head and Neck Cancers Through Pixel by Pixel Kinetic Analysis of 18F-FMISO Tracer of Dynamic PET Images
Cohort 2 Pts positive at Baseline/withdrew consent
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 weeks from time of scanPopulation: N/A - data were not collected
For Cohort 1
Outcome measures
Outcome data not reported
Adverse Events
Cohort 1 (Closed to Accrual)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 47 deaths
Cohort 2 (Closed to Accrual)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Nancy Lee, MD
Memorial Sloan Kettering Cancer Center
Phone: 212-639-3341
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place