121
Participants
Start Date
August 4, 2022
Primary Completion Date
August 4, 2026
Study Completion Date
August 4, 2026
18 F-FMISO PET/CT
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.
Radiation
Total Radiation Dose (over 3 weeks) 30Gy\*\* in 2 Gy per fraction
Cisplatin
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.
Carboplatin
"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)"
5-fluorouracil
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).
RECRUITING
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York
RECRUITING
Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison
RECRUITING
Memorial Sloan Kettering Nassau (Limited Protocol Activities), Uniondale
RECRUITING
Memorial Sloan Kettering Cancer Center at Suffolk-Commack (Limited Protocol Activities), Commack
RECRUITING
Memorial Sloan Kettering Cancer Center at Basking Ridge (Limited Protocol Activities), Basking Ridge
RECRUITING
Memorial Sloan Kettering Monmouth (Limited Protocol Activities), Middletown
RECRUITING
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale
Memorial Sloan Kettering Cancer Center
OTHER