Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer
|ClinicalTrials.gov Identifier: NCT00006051|
Recruitment Status : Unknown
Verified November 2001 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : March 25, 2004
Last Update Posted : February 9, 2009
RATIONALE: Drugs used in chemotherapy use 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. Combining more than one chemotherapy drug with radiation therapy may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation therapy in treating patients who have head and neck cancer.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: cisplatin Drug: fluorouracil Radiation: radiation therapy||Phase 2|
OBJECTIVES: I. Determine the toxicity of fluorouracil and cisplatin with concurrent radiotherapy in patients with stage I-IVB squamous cell cancer of the head and neck at high risk of recurrence following curative resection. II. Determine the efficacy of this regimen in these patients. III. Determine the survival of these patients treated with this regimen.
OUTLINE: This is a multicenter study. Patients receive fluorouracil IV continuously on days 1-5 and 43-47 and cisplatin IV over 1 hour on days 2, 23, and 44. Concurrent radiotherapy is administered 5 days a week for 6.5 weeks. Patients are followed every 3 months for 2 years, then every 6 months for 3 years.
PROJECTED ACCRUAL: A total of 44-68 patients will be accrued for this study within 18 months.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Combination Chemotherapy Concurrent With Postoperative Radiotherapy Epidermoid Carcinoma of the Head and Neck at High Risk of Recurrence - Study of Feasibility|
|Study Start Date :||February 1999|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00006051
|Centre Jean Perrin|
|Clermont-Ferrand, France, 63011|
|Hopital Jean Monnet|
|Epinal, France, 88021|
|CRLCC Nantes - Atlantique|
|Nantes-Saint Herblain, France, 44805|
|Centre Hospitalier Universitaire Bretonneau de Tours|
|Tours, France, 37044|
|Centre Alexis Vautrin|
|Vandoeuvre-les-Nancy, France, 54511|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Study Chair:||Lionnel Geoffrois, MD||Centre Alexis Vautrin|