Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer That Has Been Removed During Surgery
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|ClinicalTrials.gov Identifier: NCT00002670|
Recruitment Status : Completed
First Posted : June 10, 2004
Last Update Posted : January 24, 2014
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. It is not yet known whether radiation therapy plus cisplatin is more effective than radiation therapy alone in treating patients with head and neck cancer.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy plus cisplatin with radiation therapy alone in treating patients with head and neck cancer that has been removed during surgery.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: chemotherapy Drug: cisplatin Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET electron therapy Radiation: low-LET photon therapy||Phase 3|
OBJECTIVES: I. Evaluate locoregional control rates, patterns of first failure, and overall and disease-free survival in patients with advanced squamous cell carcinoma of the head and neck at high risk of locoregional recurrence who are treated postoperatively with concurrent cisplatin and radiotherapy. II. Compare the toxicity of concurrent chemoradiotherapy vs. radiotherapy alone in the postoperative setting.
OUTLINE: Randomized study. Arm I: Radiotherapy. Involved-field irradiation using Co60, 1-6 MV photons, or electrons. Arm II: Radiotherapy plus Single-Agent Chemotherapy. Irradiation as in Arm I; plus Cisplatin, CDDP, NSC-119875.
PROJECTED ACCRUAL: 438 patients will be entered over approximately 5 years.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||459 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase III Intergroup Trial of Surgery Followed by (1) Radiotherapy vs. (2) Radiochemotherapy For Resectable High Risk Squamous Cell Carcinoma of the Head and Neck|
|Study Start Date :||September 1995|
|Actual Primary Completion Date :||July 2002|
|Actual Study Completion Date :||November 2013|
U.S. FDA Resources
Active Comparator: Radiation therapy
Radiation therapy - 60 Gy in 6 weeks (2 Gy once a day, 5 x a week)
|Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET electron therapy Radiation: low-LET photon therapy|
Experimental: Radiation therapy plus cisplatin
Radiation therapy - 60 Gy in 6 weeks (2 Gy once a day, 5 x a week) plus Cisplatin-100 mg/m2 i.v. on days 1,22 and 43 with radiation therapy.
|Drug: chemotherapy Drug: cisplatin Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET electron therapy Radiation: low-LET photon therapy|
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): NCT00002670
Show 23 Study Locations
|Study Chair:||Jay S. Cooper, MD, FACR, FACRO||New York University School of Medicine|
|Study Chair:||James N. Endicott, MD, PA||H. Lee Moffitt Cancer Center and Research Institute|
|Study Chair:||Julie A. Kish, MD, FACP||Josephine Ford Cancer Center|