NCT00820248

Radiation + Cisplatin or Panitumumab in Locally Advanced Stage III or Stage IV Head and Neck Cancer

A Phase III Study of Standard Fractionation Radiotherapy With Concurrent High-Dose Cisplatin Versus Accelerated Fractionation Radiotherapy With Panitumumab in Patients With Locally Advanced Stage III and IV Squamous Cell Carcinoma of the Head and Neck

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: NCIC Clinical Trials Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy in higher doses over a shorter period of time may kill more tumor cells and have fewer side effects. 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 panitumumab, 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 giving standard radiation therapy together with high-dose cisplatin is more effective than giving higher-dose radiation therapy together with panitumumab in treating patients with locally advanced head and neck cancer. PURPOSE: This randomized phase III trial is comparing two radiation therapy regimens to see how well they work when given together with cisplatin or panitumumab in treating patients with locally advanced stage III or stage IV head and neck cancer.

Detailed description

OBJECTIVES: Primary * To compare the progression-free survival (PFS) of patients with locally advanced squamous cell carcinoma of the head and neck treated with standard fractionation radiotherapy and high-dose cisplatin vs accelerated fractionation radiotherapy and panitumumab. Secondary * To compare overall survival of patients treated with these regimens. * To compare local and regional PFS of patients treated with these regimens. * To compare distant metastasis in patients treated with these regimens. * To compare adverse events, including late radiotherapy-related adverse events in patients treated with these regimens. * To compare quality of life (QOL) of patients treated with these regimens. * To compare swallowing-related QOL of patients treated with these regimens. * To compare economic evaluation (cost effectiveness analysis and cost utility), including both healthcare utilization and indirect costs. OUTLINE: This is a multicenter study. Patients are stratified according to T category (T1-3 vs T4), nodal status (N0-1 vs N2 vs N3), radiotherapy delivery modality (intensity-modulated \[IMRT\] vs 3-D conformal \[3D CRT\]), anatomic location (hypopharynx vs oral cavity vs oropharynx vs larynx), and participation in the optional swallowing impairment substudy (yes vs no). Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients undergo standard fractionation radiotherapy (IMRT or 3D CRT) once daily, 5 days a week, for 7 weeks. Patients receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy. * Arm II: Patients undergo accelerated fractionation radiotherapy (IMRT or 3D CRT) once or twice daily, 5 days a week, for 6 weeks. Patients receive panitumumab IV over 30-90 minutes 1 week prior to and on days 15 and 36 of radiotherapy. Treatment in both arms continues in the absence of disease progression or unacceptable toxicity. Quality of life (QOL) (FACT-H\&N), swallowing-related QOL (MDADI, SWAL-QOL), swallowing function (FOIS), and economic evaluations (Lost Productivity questionnaire) are assessed periodically during the study. After completion of study treatment, patients are followed periodically for at least 5 years.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
BIOLOGICAL	panitumumab	Given IV
DRUG	cisplatin	Given IV
RADIATION	3-dimensional conformal radiation therapy	Patients undergo radiotherapy
RADIATION	accelerated radiation therapy	Patients undergo accelerated fractionation radiotherapy
RADIATION	intensity-modulated radiation therapy	Patients undergo radiotherapy

Timeline

• Start date: 2008-12-30
• Primary completion: 2015-05-16
• Completion: 2017-02-17
• First posted: 2009-01-12
• Last updated: 2023-08-22
• Results posted: 2017-06-20

Locations

19 sites across 1 country: Canada