NCT02254278

Reduced-Dose Intensity-Modulated Radiation Therapy With or Without Cisplatin in Treating Patients With Advanced Oropharyngeal Cancer

A Randomized Phase II Trial for Patients With p16 Positive, Non-Smoking Associated, Locoregionally Advanced Oropharyngeal Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 316 (actual)
• Sponsor: NRG Oncology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial studies the side effects and how well modestly reduced-dose intensity-modulated radiation therapy (IMRT) with or without cisplatin works in treating patients with oropharyngeal cancer that has spread to other places in the body (advanced). Radiation therapy uses high energy x rays to kill tumor cells. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether IMRT is more effective with or without cisplatin in treating patients with oropharyngeal cancer.

Detailed description

PRIMARY OBJECTIVES: -To select the arm(s) achieving a 2-year progression-free survival rate of \>= 85% without unacceptable swallowing toxicity at 1 year. SECONDARY OBJECTIVES: * To determine patterns of failure (locoregional relapse versus distant) and survival -(overall and progression-free) at 6 months and 2 years. * To determine acute toxicity profiles at the end of radiation therapy and at 1 and 6 months. * To determine late toxicity profiles at 1 and 2 years. * To determine patient-reported swallowing outcomes at 6 months and 1 and 2 years. * To determine the predictive value of 12-14 week, post-treatment fludeoxyglucose F 18 (FDG)-positron emission tomography (PET)/computed tomography (CT) for locoregional control and progression free survival (PFS) at 2 years. * To determine the predictive value of blood and tissue biomarkers for disease outcomes at 2 years. * To determine swallowing recovery per videofluoroscopy imaging at 2 years. After completion of study treatment, patients are followed at 1 and 3 months then every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Conditions

• Stage III Oropharyngeal Squamous Cell Carcinoma
• Stage IVA Oropharyngeal Squamous Cell Carcinoma
• Stage IVB Oropharyngeal Squamous Cell Carcinoma
• Stage IVC Oropharyngeal Squamous Cell Carcinoma
• Tongue Carcinoma

Interventions

Type	Name	Description
DRUG	Cisplatin	40 mg/m2 IV (intravenously) weekly for 6 weeks
RADIATION	IMRT 6 weeks	Intensity-modulated radiation therapy (IMRT), 30 fractions over 6 weeks, 5 fractions per week, 2 Gray per fraction to total dose of 60 Gy
RADIATION	IMRT 5 weeks	Intensity-modulated radiation therapy (IMRT), 30 fractions over 5 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 60 Gy

Timeline

• Start date: 2014-10-01
• Primary completion: 2019-06-10
• Completion: 2025-09-04
• First posted: 2014-10-01
• Last updated: 2025-10-09
• Results posted: 2020-08-12

Locations

222 sites across 4 countries: United States, Canada, Ireland, Saudi Arabia