Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsored by: |
NCC Head and Neck Clinic |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003576 |
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.
Condition | Intervention | Phase |
---|---|---|
Head and Neck Cancer |
Drug: cisplatin Drug: fluorouracil Procedure: surgical procedure Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Surgery and Adjuvant Radiotherapy Versus Concurrent Chemo-Radiotherapy for Resectable (Non-Metastatic) Stage III/IV Head and Neck Squamous Cell Cancer |
Estimated Enrollment: | 200 |
Study Start Date: | January 1997 |
OBJECTIVES:
OUTLINE: This is a randomized study. Patients are stratified according to primary site of disease (oral cavity/oropharynx vs larynx/hypopharynx vs others) and nodal status (node negative vs positive).
Radiotherapy is given once a day, 5 days a week, for 6.5 weeks to the primary tumor and upper neck. Fluorouracil and cisplatin are administered by continuous infusion for 4 days beginning on day 1 of the first week of radiotherapy. A second course of fluorouracil and cisplatin is given on day 28. Patients who have failed or are suspected to have failed chemo-radiotherapy should be considered for salvage surgery.
Patients are followed once a month for the first year, every 2 months for the second year, every 3 months for the third year, and every 6 months thereafter.
PROJECTED ACCRUAL: Approximately 200 patients will be accrued over a 4-5 year period.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Stage III or IV disease
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Study ID Numbers: | CDR0000066643, NMRC-SHN01, EU-97015 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003576 History of Changes |
Health Authority: | United States: Federal Government |
stage III squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the hypopharynx |
stage IV squamous cell carcinoma of the hypopharynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity |
Antimetabolites Immunologic Factors Laryngeal Carcinoma Adjuvants, Immunologic Squamous Cell Carcinoma Immunosuppressive Agents Carcinoma |
Hypopharyngeal Cancer Cisplatin Head and Neck Neoplasms Fluorouracil Epidermoid Carcinoma Carcinoma, Squamous Cell |
Antimetabolites Antimetabolites, Antineoplastic Molecular Mechanisms of Pharmacological Action Immunologic Factors Antineoplastic Agents Physiological Effects of Drugs Immunosuppressive Agents |
Pharmacologic Actions Neoplasms Neoplasms by Site Head and Neck Neoplasms Fluorouracil Therapeutic Uses |