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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002932
• Other study ID #: RTOG-9615
• Secondary ID: CDR0000065366
• Status: Completed
• Phase: Phase 2
• First received: November 1, 1999
• Last updated: November 19, 2014
• Start date: May 1997
• Est. completion date: March 2005

Study information

• Verified date: November 2014
• Source: Radiation Therapy Oncology Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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. VI. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2005
• Est. primary completion date: March 2001
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

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

Intervention

Drug:
• cisplatin

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Marlene & Stewart Greenebaum Cancer Center, University of Maryland	Baltimore	Maryland
United States	Fletcher-Allen Health Care	Burlington	Vermont
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	University of California San Diego Cancer Center	La Jolla	California
United States	CCOP - Baptist Cancer Institute	Memphis	Tennessee
United States	University of Tennessee, Memphis Cancer Center	Memphis	Tennessee
United States	Vanderbilt Cancer Center	Nashville	Tennessee
United States	MBCCOP - LSU Medical Center	New Orleans	Louisiana
United States	Naval Medical Center, Portsmouth	Portsmouth	Virginia
United States	Green Mountain Oncology Group	Rutland	Vermont
United States	UCSF Cancer Center and Cancer Research Institute	San Francisco	California
United States	University Cancer Center	Seattle	Washington
United States	University of Washington Neutron Facility and Cancer Center	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
Radiation Therapy Oncology Group	National Cancer Institute (NCI), NRG Oncology

Country where clinical trial is conducted

United States, 

References & Publications (6)

Kumar P, Harris J, Garden AS, et al.: Outcome comparisons of four Radiation Therapy Oncology Group (RTOG) trials in patients with stage IV-T4 head and neck (H/N) cancer: encouraging results using intra-arterial (IA) cisplatin (P) and concurrent radiation therapy (RT). [Abstract] J Clin Oncol 22 (Suppl 14): A-5527, 494s, 2004.

Kumar P, Harris J, Robbins KT, et al.: The feasibility of using intra-arterial cisplatin & radiation therapy for stage IV-T4 head/neck squamous cell carcinoma in a multi-institutional setting: preliminary results of Radiation Therapy Oncology Group (RTOG)

Kumar P, Robbins KT, Harris J, et al.: Intra-arterial (IA) cisplatin (P) and radiation therapy (RT) is feasible in a multi-institutional setting for the treatment of stage IV-T4 head/neck (H/N) squamous cell carcinoma (SCCa): initial results of Radiation

Kumar P, Robbins KT, Harris J, et al.: Mature results of Radiation Therapy Oncology Group (RTOG) trial 9615 using intra-arterial cisplatin (IA-P) and concurrent radiation therapy (RT) for stage IV-T4 head/neck (H/N) squamous cell carcinoma (SCCa). [Abstra

Robbins KT, Kumar P, Harris J, McCulloch T, Cmelak A, Sofferman R, Levine P, Weisman R, Wilson W, Weymuller E, Fu K. Supradose intra-arterial cisplatin and concurrent radiation therapy for the treatment of stage IV head and neck squamous cell carcinoma is — View Citation

Targeted chemoradiation (RTOG 96-15) (RADPLAT) for T4 carcinoma of the upper aerodigestive tract: interim analysis of a multi-institutional trial. [Abstract] Proceedings of the International Conference on Head and Neck Cancer A046, 78, 2000.