De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal SCC: Follow-up Study

PHASE2CompletedINTERVENTIONAL
Enrollment

115

Participants

Timeline

Start Date

August 31, 2014

Primary Completion Date

November 30, 2019

Study Completion Date

November 24, 2024

Conditions
Carcinoma, Squamous CellHead and Neck NeoplasmsOropharyngeal Neoplasms
Interventions
RADIATION

Intensity Modulated Radiotherapy (IMRT)

All patients will receive Intensity Modulated Radiotherapy Treatments (IMRT). Dose painting IMRT will be used and all doses will be specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) will be treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR will be 2 Gy per day and 1.8 Gy per day respectively. The PTV-HR will include the gross tumor and the PTV-SR will include areas at risk for harboring subclinical microscopic disease.

DRUG

Cisplatin (or alternative)

Cisplatin is the preferred mandated first choice chemotherapy, however alternative weekly regimens are permissible. Justification for not using cisplatin must be documented. Chemotherapy will be given intravenously weekly during IMRT. 6 total doses will be given. It is preferred that the doses be administered on days 1, 8, 15, 22, 29, and 36; however, this is not mandatory. Chemotherapy will not be given to patients with T0-2 N0-1 disease, ≤ 10 pack years smoking history.

PROCEDURE

Assessment for surgical evaluation

Decisions for surgical evaluation will be based on the results of the PET/CT 10 to 16 weeks after CRT and clinical exam (including fiberoptic laryngoscopy) at that time. Other optional imaging studies may be performed. Patients with a positive PET/CT scan will undergo surgical evaluation at the discretion of the surgeon, with the goal being to remove any suspected residual tumor with a negative resection margin while maintaining organ preservation. This may include biopsies and/or oncological resections of the primary tumor and lymph node metastases. Patients with a negative PET/CT scan will be observed.

Trial Locations (5)

27262

High Point Regional Health, High Point

27599

University of North Carolina at Chapel Hill, Department of Radiation Oncology, Chapel Hill

27607

Rex Healthcare, Raleigh

28791

Pardee Memorial Hospital, Hendersonville

32610

University of Florida, Gainesville

All Listed Sponsors
lead

UNC Lineberger Comprehensive Cancer Center

OTHER

NCT02281955 - De-intensification of Radiation and Chemotherapy for Low-Risk HPV-related Oropharyngeal SCC: Follow-up Study | Biotech Hunter | Biotech Hunter