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Combination Chemotherapy Concurrent With Postoperative Radiotherapy Epidermoid Carcinoma of the Head and Neck at High Risk of Recurrence - Study of Feasibility


Phase 2
18 Years
70 Years
Open (Enrolling)
Both
Head and Neck Cancer

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Trial Information

Combination Chemotherapy Concurrent With Postoperative Radiotherapy Epidermoid Carcinoma of the Head and Neck at High Risk of Recurrence - Study of Feasibility


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Lionnel Geoffrois, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Centre Alexis Vautrin

Authority:

United States: Federal Government

Study ID:

CDR0000068073

NCT ID:

NCT00006051

Start Date:

February 1999

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

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