Radiation Therapy and Cisplatin in Treating Patients With Advanced Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00005088|
Recruitment Status : Completed
First Posted : May 26, 2004
Last Update Posted : November 19, 2013
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 or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: cisplatin Radiation: radiation therapy||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II Trial of Concomitant Boost Radiation and Concurrent Cisplatin for Advanced Head and Neck Carcinomas|
|Study Start Date :||April 2000|
|Actual Primary Completion Date :||January 2002|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00005088
Show 258 Study Locations
|Study Chair:||K. Kian Ang, MD, PhD||M.D. Anderson Cancer Center|