Cisplatin and Radiation Therapy in Treating Patients With Stage IV Cancer of the Head and Neck

Sponsor

Radiation Therapy Oncology Group (Other)

Overall Status

Completed

CT.gov ID

NCT00002932

Collaborator

National Cancer Institute (NCI) (NIH), NRG Oncology (Other)

Enrollment

Locations

Duration (Months)

4.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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. Combining radiation therapy with chemotherapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of cisplatin and radiation therapy in treating patients with stage IV cancer of the head and neck.

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer	Drug: cisplatin Radiation: radiation therapy	Phase 2

Detailed Description

OBJECTIVES: I. Determine the percentage of patients for whom a complete course of therapy can be administered using targeted supradose cisplatin chemoradiation in patients with squamous cell carcinoma of the head and neck. II. Determine the partial and complete response rate of cisplatin chemoradiation. III. Determine the incidence of adverse events using cisplatin chemoradiation therapy. IV. Determine the rate of disease-free survival and overall survival in these patients. V. Determine the incidence and pattern of recurrence in these patients.

Document quality of life measured by disease-specific instruments in these patients.

OUTLINE: All patients receive four courses of cisplatin on days 1, 8, 15, and 22 concurrent with radiotherapy. One course of chemotherapy consists of intra-arterial cisplatin given over 3-5 minutes. Radiotherapy is given 5 days a week for 7 weeks. This weekly cisplatin chemoradiation course will be repeated 4 times, providing recovery from toxicity is present. Dexamethasone is started the evening prior to cisplatin treatment, and continues until the morning following the procedure.

PROJECTED ACCRUAL: 60 patients will be enrolled.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Primary Purpose:

Treatment

Official Title:

Phase II Multi-Institutional Trial of Targeted Supradose Cisplatin Chemoradiation for Stage IV Squamous Cell Carcinoma of the Head and Neck

Study Start Date :

May 1, 1997

Actual Primary Completion Date :

Mar 1, 2001

Actual Study Completion Date :

Mar 1, 2005

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS: Histologically proven squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or larynx No distant metastatic disease No previous or concurrent head and neck primaries No lip, nasopharynx, or salivary gland lesions No recurrent tumors Stage IV disease comprised of T4 NO-3 lesions

PATIENT CHARACTERISTICS: Age: 18 and over Performance Status: Karnofsky greater than 60 Life Expectancy: Not specified Hematopoietic: ANC greater than 2,000 Platelet count greater than 100,000 Hepatic: Not specified Renal: Creatinine clearance greater than 50 mL/min Cardiovascular: Not specified Other: Not pregnant or nursing No adverse medical illnesses No imaging studies performed greater than one month preregistration No laboratory studies greater than 2 weeks preregistration No other malignancies, except for basal or squamous cell of the skin, within the past 5 years

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the head and neck Surgery: No prior surgery to study site other than a biopsy Other: Protocol treatment must begin within 8 weeks of biopsy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California San Diego Cancer Center	La Jolla	California	United States	92093-0658
2	UCSF Cancer Center and Cancer Research Institute	San Francisco	California	United States	94115-0128
3	University of Iowa Hospitals and Clinics	Iowa City	Iowa	United States	52242
4	MBCCOP - LSU Medical Center	New Orleans	Louisiana	United States	70112
5	Marlene & Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland	United States	21201
6	CCOP - Baptist Cancer Institute	Memphis	Tennessee	United States	38117
7	University of Tennessee, Memphis Cancer Center	Memphis	Tennessee	United States	38163
8	Vanderbilt Cancer Center	Nashville	Tennessee	United States	37232-6838
9	Fletcher-Allen Health Care	Burlington	Vermont	United States	05401
10	Green Mountain Oncology Group	Rutland	Vermont	United States	05701
11	Naval Medical Center, Portsmouth	Portsmouth	Virginia	United States	23708-2197
12	University Cancer Center	Seattle	Washington	United States	98195
13	University of Washington Neutron Facility and Cancer Center	Seattle	Washington	United States	98195