Combination Chemotherapy Plus Radiation Therapy in Treating Patients With Head and Neck Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2001 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006051
First received: July 5, 2000
Last updated: February 6, 2009
Last verified: November 2001
  Purpose

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 Intervention Phase
Head and Neck Cancer
Drug: cisplatin
Drug: fluorouracil
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Combination Chemotherapy Concurrent With Postoperative Radiotherapy Epidermoid Carcinoma of the Head and Neck at High Risk of Recurrence - Study of Feasibility

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: February 1999
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: Histologically proven stage I-IVB squamous cell cancer of the oral cavity, oropharynx, hypopharynx, or larynx Positive lymph nodes allowed, either bilateral or contralateral Curatively resected within past 6 weeks No distant metastases

PATIENT CHARACTERISTICS: Age: Over 18 to 70 Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 2,000/mm3 Platelet count at least 150,000/mm3 Hepatic: Bilirubin less than 1.5 times upper limit of normal (ULN) SGOT and SGPT less than 2 times ULN Alkaline phosphatase less than 2 times ULN Renal: Creatinine no greater than 1.5 mg/dL OR Creatinine clearance greater than 70 mL/min Cardiovascular: No contraindication to fluorouracil IV No coronary artery disease greater than grade 2 No unstable heart disease Other: No other malignancy except basal cell skin cancer or carcinoma in situ of the cervix 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 Surgery: See Disease Characteristics Other: No other concurrent adjuvant therapy No concurrent preventive treatment (e.g., retinoids) No other concurrent experimental treatment

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006051

Locations
France
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
Sponsors and Collaborators
UNICANCER
Investigators
Study Chair: Lionnel Geoffrois, MD Centre Alexis Vautrin
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00006051     History of Changes
Other Study ID Numbers: CDR0000068073, FRE-FNCLCC-GORTEC98-01/98007, EU-20015
Study First Received: July 5, 2000
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I squamous cell carcinoma of the lip and oral cavity
stage II squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage I squamous cell carcinoma of the oropharynx
stage II squamous cell carcinoma of the oropharynx
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
stage I squamous cell carcinoma of the hypopharynx
stage II squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
stage I squamous cell carcinoma of the larynx
stage II squamous cell carcinoma of the larynx
stage III squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Head and Neck Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Neoplasms by Site
Cisplatin
Fluorouracil
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014