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Sponsored by: |
NCC Head and Neck Clinic |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00003637 |
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 radiation therapy alone is more effective than radiation therapy plus chemotherapy in treating cancer of the nasopharynx.
PURPOSE: This randomized phase III trial is studying how well radiation therapy and chemotherapy works compared to radiation therapy alone in treating patients with previously untreated cancer of the nasopharynx.
Condition | Intervention | Phase |
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Head and Neck Cancer |
Drug: cisplatin Drug: fluorouracil Radiation: radiation therapy |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Active Control |
Official Title: | Standard Radiotherapy Versus Concurrent Chemo-Radiotherapy Followed by Adjuvant Chemotherapy for Locally Advanced (Non-Metastatic) Nasopharyngeal Cancer |
Estimated Enrollment: | 200 |
Study Start Date: | September 1998 |
OBJECTIVES:
OUTLINE: This is a randomized study.
Patients are randomized to receive radiotherapy alone (arm I) or concurrent chemoradiotherapy followed by adjuvant chemotherapy (arm II).
Concurrent radiotherapy is given once daily 5 times a week over the 7 week treatment period. This chemoradiotherapy is followed 3 weeks later by adjuvant chemotherapy. Patients receive cisplatin IV and fluorouracil IV over 6-8 hours for 4 consecutive days every 4 weeks for 3 courses.
Patients are followed every 4 months for the first year, every 6 months for the next 2 years, and then annually thereafter until death.
PROJECTED ACCRUAL: A minimum of 200 patients will be accrued for this study.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Study ID Numbers: | CDR0000066722, NMRC-SQNP01, EU-98047 |
Study First Received: | November 1, 1999 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00003637 History of Changes |
Health Authority: | United States: Federal Government |
stage III lymphoepithelioma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx stage III squamous cell carcinoma of the nasopharynx stage IV lymphoepithelioma of the nasopharynx |
Antimetabolites Otorhinolaryngologic Neoplasms Otorhinolaryngologic Diseases Nasopharyngeal Carcinoma Immunologic Factors Adjuvants, Immunologic Pharyngeal Neoplasms Squamous Cell Carcinoma Immunosuppressive Agents |
Pharyngeal Diseases Nasopharyngeal Neoplasms Carcinoma Cisplatin Head and Neck Neoplasms Fluorouracil Epidermoid Carcinoma Stomatognathic Diseases Carcinoma, Squamous Cell |
Antimetabolites Otorhinolaryngologic Neoplasms Otorhinolaryngologic Diseases Antimetabolites, Antineoplastic Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Pharyngeal Neoplasms Immunosuppressive Agents |
Pharyngeal Diseases Pharmacologic Actions Nasopharyngeal Neoplasms Neoplasms Neoplasms by Site Therapeutic Uses Head and Neck Neoplasms Fluorouracil Nasopharyngeal Diseases Stomatognathic Diseases |