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Adjuvant Chemoradiotherapy Using Cisplatin and Docetaxel After Complete Resection in Treating Patients With Stage III or Stage IV Squamous Cell Carcinoma of the Head and Neck
This study is not yet open for patient recruitment.
Sponsored by: | Southwest Oncology Group |
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Information provided by: | National Cancer Institute (NCI) |
Purpose
RATIONALE: Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Cisplatin and docetaxel may make the tumor cells more sensitive to radiation therapy. Giving chemoradiotherapy after surgery may kill any remaining tumor cells.
PURPOSE: Phase II trial to study the effectiveness of adjuvant chemoradiotherapy using cisplatin and docetaxel in treating patients who have completely resected stage III or stage IV squamous cell carcinoma (cancer) of the head and neck.
Condition | Treatment or Intervention | Phase |
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Hypopharyngeal Cancer Laryngeal Cancer lip and oral cavity cancer Oropharyngeal Cancer paranasal sinus and nasal cavity cancer Salivary Gland Cancer |
Drug: cisplatin Drug: docetaxel Procedure: chemotherapy Procedure: radiation therapy Procedure: radiosensitization |
Phase II |
MedlinePlus related topics: Head and Neck Cancer; Nasal Cancer; Oral Cancer; Salivary Gland Disorders
Study Type: Interventional
Study Design: Treatment
Official Title: Phase II Study of Adjuvant Chemoradiotherapy Comprising Cisplatin and Docetaxel After Complete Resection in Patients With Stage III or IV Squamous Cell Carcinoma of the Head and Neck
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36 and cisplatin IV over 1.5 hours on days 1, 22, and 43. Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-45. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months for up to 3 years from registration.
PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study within 17.5-23.5 months.
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
Location Information
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
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