Head and Neck Cancer
Conditions
Keywords
Head, Neck, 04-070
Brief summary
The main purpose of this study is to evaluate low oxygen areas called hypoxia within tumors. These low oxygen areas are thought to be the reason why tumors are more resistant to chemotherapy and radiation treatment. An imaging technique using a hypoxia tracer called fluoromisonidazole (FMISO) can detect low oxygen areas within a tumor. This imaging technique, called a PET scan, uses positively charged particles to detect slight changes in the body's biochemistry and metabolism. FMISO PET scans have been performed in patients with head and neck cancer and have shown the ability to detect low oxygen areas within tumors.
Interventions
RADIATIONfluorine-18-labeled fluoro-misonidazole (18F-FMISO)
DEVICE18F-FMISO PET scan
DEVICEMRI
DEVICEFDG PET/CT scan
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for Cohort 1 and Cohort 2 : * Histologically confirmed diagnosis of head and neck carcinoma (excluding nasopharynx, paranasal sinus, salivary, and thyroid malignancies)Any unknown primary squamous cell carcinoma of head and neck with gross nodes is allowed (2002 AJCC) * 18 years of age or older * Must not have received prior radiation therapy or chemotherapy for this diagnosis. Patients who have had their primary site tumor removed by surgery but still present with grossly enlarged lymph nodes are eligible for this study. * Karnofsky performance status ≥ 70.
Exclusion criteria
for Cohort 1 and Cohort 2: * all nasopharyngeal, paranasal sinus, salivary cancer, and thyroid malignancies * prior chemotherapy or radiotherapy within the last three years * patients that underwent previous surgical resection for the same disease (except for biopsy or surgery removing primary site tumor but still present with grossly enlarged lymph nodes) * any prior radiotherapy to the head and neck region * pregnant (confirmed by serum b-HCG in women of reproductive age) or breast feeding Subject
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Report Positive Versus Negative Hypoxia Among Head and Neck Cancers Using 18F-FMISO Dynamic PET | 4 months | For Cohort 1 |
| To Determine the Pathologic Complete Response of Low Risk HPV+ Oropharyngeal Cancer Patients Without Hypoxia on 18F-FMISO PET Who Received 30Gy | 4 months | For Cohort 2 - Feasibility will be determined by the pathologic response rate at time of neck dissection |
| 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 | At baseline | Cohort 2 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Detect on Repeat 18F-FMISO PET/CT Scans Whether There is a Reduction of the FMISO-avid or GTVh 5 to 10 Days Into Treatment With Standard Chemoradiotherapy for a Series of Locally Advanced Head and Neck Cancers. | 2 weeks from time of scan | For Cohort 1 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 197 |
| 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. | 19 |
| Total | 216 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 36 | 0 |
Baseline characteristics
| Characteristic | Cohort 1 (Closed to Accrual) | Total | Cohort 2 (Closed to Accrual) |
|---|---|---|---|
| Age, Continuous | 58 years | 58 years | 57 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 9 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 189 Participants | 207 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 3 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants | 10 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 18 Participants | 20 Participants | 2 Participants |
| Race (NIH/OMB) White | 166 Participants | 183 Participants | 17 Participants |
| Region of Enrollment United States | 197 Participants | 216 Participants | 19 Participants |
| Sex: Female, Male Female | 23 Participants | 26 Participants | 3 Participants |
| Sex: Female, Male Male | 174 Participants | 190 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 47 / 197 | 2 / 19 |
| other Total, other adverse events | 0 / 197 | 0 / 19 |
| serious Total, serious adverse events | 0 / 197 | 0 / 19 |
Outcome results
Primary
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
Time frame: At baseline
Population: This objective is for Cohort 2 participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 (Closed to Accrual) | 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 |
| Cohort 1 (Closed to Accrual) | 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 |
| Cohort 1 (Closed to Accrual) | 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 |
| Cohort 1 (Closed to Accrual) | 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 |
| Cohort 2 (Closed to Accrual) | 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 | 1 Participants |
| Cohort 2 (Closed to Accrual) | 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 | 6 Participants |
| Cohort 2 (Closed to Accrual) | 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 | 9 Participants |
| Cohort 2 (Closed to Accrual) | 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 | 3 Participants |
Primary
To Determine the Pathologic Complete Response of Low Risk HPV+ Oropharyngeal Cancer Patients Without Hypoxia on 18F-FMISO PET Who Received 30Gy
For Cohort 2 - Feasibility will be determined by the pathologic response rate at time of neck dissection
Time frame: 4 months
Population: This objective is for Cohort 2 participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 (Closed to Accrual) | 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 |
| Cohort 1 (Closed to Accrual) | 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 |
| Cohort 1 (Closed to Accrual) | 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 |
| Cohort 2 (Closed to Accrual) | 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 | 11 Participants |
| Cohort 2 (Closed to Accrual) | 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 | 4 Participants |
| Cohort 2 (Closed to Accrual) | 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 | 4 Participants |
Primary
To Report Positive Versus Negative Hypoxia Among Head and Neck Cancers Using 18F-FMISO Dynamic PET
For Cohort 1
Time frame: 4 months
Population: This objective is for Cohort 1 participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 (Closed to Accrual) | To Report Positive Versus Negative Hypoxia Among Head and Neck Cancers Using 18F-FMISO Dynamic PET | Participants who are hypoxia positive | 135 Participants |
| Cohort 1 (Closed to Accrual) | To Report Positive Versus Negative Hypoxia Among Head and Neck Cancers Using 18F-FMISO Dynamic PET | Participants who are hypoxia negative | 26 Participants |
| Cohort 1 (Closed to Accrual) | To Report Positive Versus Negative Hypoxia Among Head and Neck Cancers Using 18F-FMISO Dynamic PET | Participants declined scans | 36 Participants |
| Cohort 2 (Closed to Accrual) | To Report Positive Versus Negative Hypoxia Among Head and Neck Cancers Using 18F-FMISO Dynamic PET | Participants who are hypoxia positive | 0 Participants |
| Cohort 2 (Closed to Accrual) | To Report Positive Versus Negative Hypoxia Among Head and Neck Cancers Using 18F-FMISO Dynamic PET | Participants who are hypoxia negative | 0 Participants |
| Cohort 2 (Closed to Accrual) | To Report Positive Versus Negative Hypoxia Among Head and Neck Cancers Using 18F-FMISO Dynamic PET | Participants declined scans | 0 Participants |
Secondary
To Detect on Repeat 18F-FMISO PET/CT Scans Whether There is a Reduction of the FMISO-avid or GTVh 5 to 10 Days Into Treatment With Standard Chemoradiotherapy for a Series of Locally Advanced Head and Neck Cancers.
For Cohort 1
Time frame: 2 weeks from time of scan
Population: N/A - data were not collected