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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier:
NCT00002932
First received: November 1, 1999
Last updated: November 11, 2013
Last verified: November 2013
  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 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 Intervention Phase
Head and Neck Cancer
Drug: cisplatin
Radiation: radiation therapy
Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Radiation Therapy Oncology Group:

Estimated Enrollment: 60
Study Start Date: May 1997
Primary Completion Date: March 2001 (Final data collection date for primary outcome measure)
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. 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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: NCT00002932

Locations
United States, California
University of California San Diego Cancer Center
La Jolla, California, United States, 92093-0658
UCSF Cancer Center and Cancer Research Institute
San Francisco, California, United States, 94115-0128
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Louisiana
MBCCOP - LSU Medical Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
Marlene & Stewart Greenebaum Cancer Center, University of Maryland
Baltimore, Maryland, United States, 21201
United States, Tennessee
CCOP - Baptist Cancer Institute
Memphis, Tennessee, United States, 38117
University of Tennessee, Memphis Cancer Center
Memphis, Tennessee, United States, 38163
Vanderbilt Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Vermont
Fletcher-Allen Health Care
Burlington, Vermont, United States, 05401
Green Mountain Oncology Group
Rutland, Vermont, United States, 05701
United States, Virginia
Naval Medical Center, Portsmouth
Portsmouth, Virginia, United States, 23708-2197
United States, Washington
University Cancer Center
Seattle, Washington, United States, 98195
University of Washington Neutron Facility and Cancer Center
Seattle, Washington, United States, 98195
Sponsors and Collaborators
Radiation Therapy Oncology Group
Investigators
Study Chair: K. Thomas Robbins, MD University of Florida
  More Information

Additional Information:
Publications:
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). [Abstract] J Clin Oncol 23 (Suppl 16): A-5579, 519s, 2005.
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 Therapy Oncology Group (RTOG) trial 9615. [Abstract] Proceedings of the American Society of Clinical Oncology 20: A-918, 230a, 2001.
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.
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) trial 9615. Int J Radiat Oncol Biol Phys 48(3 suppl): A-81, 152, 2000.
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.

Responsible Party: Radiation Therapy Oncology Group
ClinicalTrials.gov Identifier: NCT00002932     History of Changes
Other Study ID Numbers: RTOG-9615, CDR0000065366
Study First Received: November 1, 1999
Last Updated: November 11, 2013
Health Authority: United States: Federal Government

Keywords provided by Radiation Therapy Oncology Group:
stage IV squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the hypopharynx
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
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on July 31, 2014