Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Recurrent Head and Neck Cancer

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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. Drugs such as amifostine may prevent the side effects of radiation therapy. Combining more than one drug and combining radiation therapy and surgery with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining surgery, radiation therapy, and combination chemotherapy in treating patients who have recurrent head and neck cancer that has been treated previously with radiation therapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abramson Cancer Center of the University of Pennsylvania; University of Pennsylvania
• Treatments: Amifostine; Fluorouracil

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed recurrent or new primary squamous cell carcinoma of the head and neck occurring in a previously irradiated field

• Pathologic stage of recurrence must be rT3-4 and/or rN2-3

• The following sites are eligible:

• Oral cavity, oropharynx, or hypopharynx: Any rT2-4 and/or clinical rN+

• Larynx: Any rT4, rT3 with perineural invasion, or any rT with clinical rN+

• Any site: Positive margin(s), at least 2 nodes or ECS

• No primary tumor of the nasopharynx

• Must be eligible for or have undergone complete resection which leaves behind no gross residual disease

• Must have prior head and neck irradiation of 45-75 Gy

• Lifetime spinal cord radiotherapy dose no greater than 50 Gy

• No ongoing RTOG late morbidity of grade 3 or greater (unless correctable by surgery)

• No active acute radiation mucositis from previous radiotherapy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• Karnofsky 70-100%

Life expectancy:

• Not specified

Hematopoietic:

• WBC at least 4,000/mm^3

• Hemoglobin at least 9 g/dL (transfusion allowed)

• Platelet count at least 100,000/mm^3

Hepatic:

• SGOT or SGPT no greater than 3 times upper limit of normal

• Bilirubin no greater than 2 mg/dL

Renal:

• Creatinine no greater than 1.5 mg/dL

Cardiovascular:

• No myocardial infarction, unstable angina, coronary heart failure, or uncontrolled arrhythmias within past 6 months

• No severe cerebrovascular disease or hypotension not caused by antihypertensive medication

Other:

• Not pregnant

• Fertile patients must use effective contraception

• No allergy to cisplatin, fluorouracil, or amifostine

• No uncontrolled insulin-dependent diabetes mellitus or other medical condition interfering with wound healing

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy for tumor recurrence (except adjuvant chemotherapy)

Endocrine therapy:

• Not specified

Radiotherapy:

• See Disease Characteristics

• At least 6 months since prior radiotherapy

• Prior radiotherapy treatment records must be available

Surgery:

• No prior salvage surgery consisting of partial laryngectomy