The Quarterback Trial: A Randomized Phase III Clinical Trial Comparing Reduced and Standard Radiation Therapy Doses for Locally Advanced HPV16 Positive Oropharynx Cancer
This is a randomized Phase III study comparing two doses of definitive radiation therapy
given with induction and concurrent chemotherapy in HPV-positive oropharynx, unknown primary
or nasopharynx cancer. Eligible, consented and registered patients will receive three cycles
of Docetaxel Cisplatin and 5-FU (TPF) induction chemotherapy. After 3 cycles, the patients
will be assessed for clinical, radiographic and pathologic response to TPF. Patients with a
clinical or radiographic CR or PR will be randomized on the second phase of this study,
where patients will undergo a 2:1 randomization to reduced (5600 cGy) or standard (7000 cGy)
dose radiotherapy with weekly Carboplatin and Erbitux or carboplatin only, respectively.
Patients not meeting the response criteria will be treated with standard dose CRT. Patients
not completing 3 cycles TPF for reasons of toxicity, progressive disease, choice, or other
medical necessity will be treated with standard dose CRT or surgery depending on their
primary site and overall medical condition and followed for survival. Toxicity will be
assessed by Symptom scores, QOL and SAE monitoring. The primary end point of the trial is
equivalent local regional control and PFS at 3 years. Patients will be followed for 5 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Progression Free Survival (PFS)
To determine the comparative rate of progression free survival (PFS) at 3 years in patients with advanced HPV related oropharynx cancer, nasopharynx cancer or unknown primary treated with reduced or standard dose radiation.
at 3 years
Marshall Posner, M.D.
Icahn School of Medicine at Mount Sinai
United States: Institutional Review Board
|John Theurer Cancer Center at Hackensack University Medical Center||Hackensack, New Jersey 07601|
|Icahn School of Medicine at Mount Sinai||New York, New York 10029|