NCT01302834

Radiation Therapy With Cisplatin or Cetuximab in Treating Patients With Oropharyngeal Cancer

Phase III Trial of Radiotherapy Plus Cetuximab Versus Chemoradiotherapy in HPV-Associated Oropharynx Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 987 (actual)
• Sponsor: Radiation Therapy Oncology Group · Network
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells and shrink tumors. Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether radiation therapy is more effective with cisplatin or cetuximab in treating oropharyngeal cancer. PURPOSE: This phase III trial is studying radiation therapy with cisplatin or cetuximab to see how well it works in treating patients with oropharyngeal cancer.

Detailed description

OBJECTIVES: Primary * To determine whether substitution of cisplatin with cetuximab will result in comparable 5-year overall survival. Secondary * To monitor and compare progression-free survival for "safety". * To compare patterns of failure (locoregional vs distant). * To compare acute toxicity profiles (and overall toxicity burden). * To compare overall quality of life (QOL) short-term (\< 6 months) and long-term (1 year). * To compare QOL Swallowing Domains short-term and long-term. * To compare clinician-reported versus patient-reported CTCAE toxicity events. * To explore differences in the cost effectiveness of cetuximab as compared to cisplatin. * To explore differences in work status and time to return to work. * To compare patient-reported changes in hearing. * To compare CTCAE v. 4 late toxicity at 1, 2, and 5 years. * To evaluate the effect of tobacco exposure (and other exposures) as measured by standardized computer-assisted self interview (CASI) on overall survival and progression-free survival. * To pilot CASI collection of patient reported outcomes in a cooperative group setting. * To determine whether specific molecular profiles are associated with overall or progression-free survival. * To investigate associations between changes in serum biomarkers or human papilloma virus (HPV)-specific cellular immune responses measured at baseline and three months with overall or progression-free survival. OUTLINE: This is a multicenter study. Patients are stratified according to T stage (T1-2 vs T 3-4), N stage (N0-2a vs N2b-3), Zubrod performance status (0 vs 1), and smoking history (≤ 10 pack-years vs \> 10 pack-years). Patients are randomized to 1 of 2 treatment arms. Patients may complete quality-of-life questionnaires and risk factors for head and neck cancer surveys at baseline, periodically during study, and at follow-up for 1 year. After completion of study therapy, patients are followed up at 1-3 months, every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Conditions

• Head and Neck Cancer
• Precancerous Condition

Interventions

Type	Name	Description
BIOLOGICAL	cetuximab	400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks
DRUG	cisplatin	100 mg/m2 IV on days 1 and 22 of IMRT
RADIATION	IMRT	35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.

Timeline

• Start date: 2011-06-01
• Primary completion: 2018-07-12
• Completion: 2025-09-04
• First posted: 2011-02-24
• Last updated: 2026-01-12
• Results posted: 2020-01-09

Locations

185 sites across 2 countries: United States, Canada