Head and Neck Cancer Clinical Trial
Official title:
Surgery and Adjuvant Radiotherapy Versus Concurrent Chemo-Radiotherapy for Resectable (Non-Metastatic) Stage III/IV Head and Neck Squamous Cell Cancer
Verified date | April 2007 |
Source | National Cancer Institute (NCI) |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Interventional |
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in
chemotherapy use different ways to stop tumor cells from dividing so they stop growing or
die. It is not yet known whether surgery plus radiation therapy is more effective than
chemotherapy plus radiation therapy for head and neck cancer.
PURPOSE: This randomized phase III trial is studying surgery and radiation therapy to see
how well they work compared to chemotherapy and radiation therapy in treating patients with
stage III or stage IV head and neck cancer that can be removed during surgery.
Status | Completed |
Enrollment | 200 |
Est. completion date | August 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
DISEASE CHARACTERISTICS: - Histologically confirmed head and neck squamous cell cancer (excluding nasopharynx and salivary glands) on biopsy of the primary lesion or the neck mass - Stage III or IV disease - No evidence of distant or systemic metastases - Resectable disease PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - WBC greater than 3000/mm^3 - Platelet count greater than 100,000/mm^3 Hepatic: - SGOT less than 2 times upper limit of normal - Bilirubin less than 1.4 mg/dL Renal: - Creatinine less than 1.6 mg/dL Other: - No prior or concurrent primary malignancies - Not pregnant - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - No prior chemotherapy Endocrine therapy: - Not specified Radiotherapy: - No prior radiotherapy to the head and neck Surgery: - See Disease Characteristics - No prior surgery (other than biopsy) |
Allocation: Randomized, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Singapore | National Cancer Centre - Singapore | Singapore |
Lead Sponsor | Collaborator |
---|---|
National Cancer Centre, Singapore |
Singapore,
Soo KC, Tan EH, Wee J, Lim D, Tai BC, Khoo ML, Goh C, Leong SS, Tan T, Fong KW, Lu P, See A, Machin D. Surgery and adjuvant radiotherapy vs concurrent chemoradiotherapy in stage III/IV nonmetastatic squamous cell head and neck cancer: a randomised compari — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Response at 6 weeks after completion of study treatment | No | ||
Primary | Disease-free survival | No | ||
Primary | Overall survival | No |
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