At a glance
ClinicalIndex Comparison Record- ✓Pathologically proven HPV-associated squamous cell carcinoma of the oropharynx
- ✓Clinically or radiographically evident measurable gross disease at primary tumor or nodal stations
- ✓No evidence of distant metastasis on FDG PET/CT
- ✓Excisional biopsy or core biopsy required
- ✕Prior head and neck radiation therapy
- ✕Simultaneous primary cancers outside oropharynx (unless approved by PI/Co-PI)
- ✕Prior invasive malignancy within 3 years (except non-melanomatous skin cancer)
- ✕Prior systemic chemotherapy for this cancer (prior chemotherapy for different cancer allowed)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Major Radiation Dose De-Escalation Concurrent With Chemotherapy for Human Papilloma Virus Associated Oropharyngeal Carcinoma
In Brief
A Phase 2 clinical trial evaluating 18 F-FMISO PET/CT, Radiation, and 3 other interventions for HPV and 4 related conditions. Currently recruiting, targeting 121 participants across 7 sites.
Signals
Detailed Summary
The purpose of this study is to find out if lower doses of radiation may help reduce the side effects of radiation therapy in combination with standard-of-care chemotherapy in people with HPV-positive throat cancer. The chemotherapy drugs used in this study include cisplatin, carboplatin, and 5-fluorouracil (5- FU), paclitaxel and abraxane- (Albumin-bound Paclitaxel).
Study Details
Timeline
Interventions
The 18F-FMISO PET/CT Scan Protocol consists first of an IV bolus injection of approximately 5-10 mCi of the radiotracer. At between 150-180 mins post injection, 18F-FMISO images will be acquired.
Total Radiation Dose (over 3 weeks) 30Gy\*\* in 2 Gy per fraction
Concurrent chemotherapy (2 cycles) will be given. At the start of week 1 of radiation, subjects will receive cisplatin 100 mg/m2 intravenously. They may be given for 2 consecutive days (50 mg/m2 each day for a total dose 100 mg/m2 ), typically on days 1 and 2, or as a single dose, typically on day 1.
If cisplatin cannot be given at 100 mg/m2 for either cycle 1 or cycle 2, the investigator may use a regimen with carboplatin and 5-Fluorouracil in its place. Carboplatin will be given at a dose of AUC 1.25 intravenously daily x 4 days starting on day 1 of the cycle (total dose of AUC 5). 5-Fluorouracil will be given at a dose of 600 mg/m2 intravenous infusion over 24 hours daily x 4 days (total dose of 2400 mg/m2 intravenous infusion over 96 hours). (Cohort B to start carboplatin (AUC 1.5) and paclitaxel 45 mg/m2 at the start of RT)
If cisplatin cannot be given at 100 mg/m2 for either cycle 1 or cycle 2, the investigator may use a regimen with carboplatin and 5-Fluorouracil in its place. Carboplatin will be given at a dose of AUC 1.25 intravenously daily x 4 days starting on day 1 of the cycle (total dose of AUC 5). 5-Fluorouracil will be given at a dose of 600 mg/m2 intravenous infusion over 24 hours daily x 4 days (total dose of 2400 mg/m2 intravenous infusion over 96 hours).