Radiation Therapy With or Without Cetuximab in Treating Patients Who Have Undergone Surgery for Locally Advanced Head and Neck Cancer
RATIONALE: Giving radiation therapy that uses a 3-dimensional (3-D) image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. 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 when given alone or together with cetuximab in treating patients with head and neck cancer that has been removed by surgery.
PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared with radiation therapy given together with cetuximab in treating patients who have undergone surgery for locally advanced head and neck cancer.
|Head and Neck Cancer||Biological: cetuximab Radiation: intensity-modulated radiation therapy||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
|Official Title:||A Phase III Study of Postoperative Radiation Therapy (IMRT) +/- Cetuximab for Locally-Advanced Resected Head and Neck Cancer|
- Overall survival [ Time Frame: From randomization to date of death or last follow-up. Analysis occurs after 372 events have been reported. ]
- Adverse events (dysphagia, xerostomia, and skin toxicity) according to CTCAE, v. 4 and their relationships with patient-reported outcomes at 3, 12, and 24 months [ Time Frame: From start of treatment to 2 years after end of treatment. ]
- Other acute adverse events (≤ 90 days from start of radiotherapy [RT]) according to CTCAE, v. 4 [ Time Frame: From start of treatment to 90 days. ]
- Other late adverse events (> 90 days from start of RT) according to CTCAE, v. 4 [ Time Frame: From 90 days after start of treatment to last follow-up. ]
- Disease-free survival [ Time Frame: From randomization to date of failure (local, regional or distant progression or death) or last follow-up. Analysis occurs at the same time as the primary outcome. ]
- Loco-regional control [ Time Frame: From randomization to date of failure (local or regional progression or distant progression or death) or last follow-up. Analysis occurs at the same time as the primary outcome. ]
- Quality of life as measured by Functional Assessment of Cancer Therapy-Head & Neck (FACT-HN) and EuroQol (EQ-5D) at baseline and at 3, 12, and 24 months [ Time Frame: From randomization to 2 years. ]
- Xerostomia as measured by University of Michigan Xerostomia-Related Quality of Life Scale (XeQOLS) at baseline and at 3, 12, and 24 months [ Time Frame: From randomization to 2 years. ]
- Swallowing as measured by the normalcy of diet subscale of the Performance Status Scale for Head and Neck Cancer (PSS-HN) at baseline and at 3, 12, and 24 months [ Time Frame: From randomization to 2 years. ]
- Skin toxicity as measured by the Dermatology Life Quality Index (DLQI) at baseline and at 3, 12, and 24 months [ Time Frame: From randomization to 2 years. ]
|Actual Study Start Date:||November 2009|
|Estimated Primary Completion Date:||August 2021 (Final data collection date for primary outcome measure)|
Active Comparator: Arm I: Intensity-Modulated Radiotherapy
Patients undergo intensity-modulated radiotherapy (IMRT) once daily 5 days a week for 6 weeks in the absence of disease progression or unacceptable toxicity.
Radiation: intensity-modulated radiation therapy
Patients undergo radiotherapy.
Experimental: Arm II: IMRT plus cetuximab
Patients undergo IMRT as in arm I. Patients also receive cetuximab IV over 1-2 hours once weekly beginning at least 5 days prior to the start of IMRT and continuing for 4 weeks after the completion of IMRT (for a total of 11 doses) in the absence of disease progression or unacceptable toxicity.
Given IVRadiation: intensity-modulated radiation therapy
Patients undergo radiotherapy.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00956007
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|Study Chair:||Mitchell Machtay, MD||University Hospitals Seidman Cancer Center|