NCT01706939

The Quarterback Trial: Reduced Dose Radiotherapy for HPV+ Oropharynx Cancer

The Quarterback Trial: A Randomized Phase III Clinical Trial Comparing Reduced and Standard Radiation Therapy Doses for Locally Advanced HPV Positive Oropharynx Cancer

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial aims to directly compare a reduced radiation dose to the standard of care in HPVOPC for non-inferiority, thus allowing for direct comparison of outcomes between the two groups. The study hypothesis is that LRC and PFS at 3 years for reduced dose CRT are non-inferior to standard dose CRT.

Detailed description

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. 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.

Conditions

• Squamous Cell Carcinomas

Interventions

Type	Name	Description
RADIATION	Reduced Dose Radiation	Reduced Dose Radiation (5600 cGy) dose radiotherapy
RADIATION	Standard Dose Radiation	Standard Dose Radiation (7000 cGy) dose radiotherapy
DRUG	Carboplatin	Day 1, every 7 days ( + 2 days)

Timeline

• Start date: 2012-09-01
• Primary completion: 2020-04-01
• Completion: 2035-05-01
• First posted: 2012-10-15
• Last updated: 2026-04-09
• Results posted: 2022-09-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study