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Radiation Therapy and Cisplatin in Treating Patients With Advanced Head and Neck Cancer

This study has been completed.
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00005088
First received: April 6, 2000
Last updated: February 6, 2009
Last verified: July 2008
History of Changes
  Purpose

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of radiation therapy and cisplatin in treating patients who have advanced head and neck cancer.


Condition Intervention Phase
Head and Neck Cancer
 Drug: cisplatin
Radiation: radiation therapy
 Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Trial of Concomitant Boost Radiation and Concurrent Cisplatin for Advanced Head and Neck Carcinomas

Resource links provided by NLM:

Drug Information available for: Cisplatin
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: April 2000
Detailed Description:

OBJECTIVES: I. Determine the rate of local regional recurrence at one year in patients with advanced head and neck cancer treated with boost radiotherapy and cisplatin. II. Determine the feasibility of treatment delivery, patient tolerance, and acute and late toxicities in these patients on this regimen. III. Determine the overall survival, disease free survival, and distant relapse rates of these patients on this regimen.

OUTLINE: Patients receive fractionated radiotherapy 1-2 times daily over 5 consecutive days for 6 weeks, and cisplatin IV over 1-2 hours on days 1 and 22. Patients may undergo salvage surgery if biopsy proven cancer remains more than 3 months after treatment. Patients are followed every 3 months for 2 years, every 6 months for 3 years, then annually until death.

PROJECTED ACCRUAL: A total of 50-56 patients will be accrued for this study within 7 months.

  Eligibility

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 Stage III or IV No distant metastases

PATIENT CHARACTERISTICS: Age: Not specified Performance status: Zubrod 0-1 Life expectancy: At least 6 months Hematopoietic: Absolute granulocyte count at least 2,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 mg/dL SGOT or SGPT no greater than 2 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Creatinine clearance at least 50 mL/min Calcium normal Cardiovascular: No symptomatic coronary artery disease No angina No myocardial infarction within the past 6 months Other: Not pregnant or nursing Fertile patients must use effective contraception No other malignancy within the past 3 years except nonmelanomatous skin cancer

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 initial surgery (except diagnostic biopsy of the primary site or neck)

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005088

  Show 258 Study Locations
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Investigators
Study Chair: K. Kian Ang, MD, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

Publications:
Garden AS, Harris J, Jones CU, et al.: Concomitant boost radiation and concurrent cisplatin for advanced head and neck carcinomas: update of a phase II trial of the RTOG (99-14). [Abstract] Int J Radiat Oncol Biol Phys 63 (2 Suppl 1): A-117, S71, 2005.
Ang KK, Harris J, Garden AS, et al.: Concomitant boost radiation and concurrent cisplatin for advanced head and neck carcinomas: preliminary results of a phase II trial of the RTOG (99-14). [Abstract] Int J Radiat Oncol Biol Phys 54(2 suppl 1): A-123, 71, 2002.
O'Meara EA, Machtay M, Moughan J, et al.: Associations between radiation doses to pharyngeal regions and severe late toxicity in head and neck cancer patients treated with concurrent chemoradiotherapy: an RTOG analysis. [Abstract] Int J Radiat Oncol Biol Phys 69 (3): A-96, S54-5, 2007.
Machtay M, Moughan J, Trotti A, et al.: Pre-treatment and treatment related risk factors for severe late toxicity after chemo-RT for head and neck cancer: an RTOG analysis. [Abstract] J Clin Oncol 24 (Suppl 18): A-5500, 280s, 2006.

ClinicalTrials.gov Identifier: NCT00005088     History of Changes
Other Study ID Numbers: CDR0000067706, RTOG-9914, RTOG-DEV-1022
Study First Received: April 6, 2000
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage III squamous cell carcinoma of the lip and oral cavity
stage IV squamous cell carcinoma of the lip and oral cavity
stage III squamous cell carcinoma of the oropharynx
stage IV squamous cell carcinoma of the oropharynx
 stage III squamous cell carcinoma of the hypopharynx
stage IV squamous cell carcinoma of the hypopharynx
stage III squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Cisplatin
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Radiation-Sensitizing Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013