Radiation Therapy With or Without Chemotherapy in Treating Patients With Advanced Cancer of the Larynx
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|ClinicalTrials.gov Identifier: NCT00002496|
Recruitment Status : Completed
First Posted : June 9, 2004
Last Update Posted : January 24, 2014
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. It is not yet known if chemotherapy plus radiation therapy is more effective than radiation therapy alone in treating patients with advanced cancer of the larynx.
PURPOSE: Randomized phase III trial to compare the effectiveness of radiation therapy with or without chemotherapy in treating patients with advanced cancer of the larynx.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Drug: chemotherapy Drug: cisplatin Drug: fluorouracil Procedure: conventional surgery Radiation: low-LET cobalt-60 gamma ray therapy Radiation: low-LET electron therapy Radiation: low-LET photon therapy||Phase 3|
OBJECTIVES: I. Compare, in a phase III setting, overall and disease-free survival with preservation of laryngeal function in patients with stage III/IV squamous cell carcinoma of the glottic and supraglottic larynx treated with cisplatin/fluorouracil (CDDP/5-FU) followed by radiotherapy vs. concomitant radiotherapy plus CDDP vs. radiotherapy alone. II. Compare the tumor response after completion of chemotherapy but prior to initiation of radiotherapy with that following completion of radiotherapy and concurrent chemotherapy. III. Compare the patterns of relapse (local and regional recurrence and distant metastasis) with these treatments. IV. Compare the incidence of second primary tumors in patients treated on these three regimens. V. Compare the acute and chronic adverse effects of these three regimens. VI. Compare the morbidity experienced with neck dissection and/or laryngeal salvage surgery following treatment with these regimens. VII. Compare quality of life of patients with laryngeal preservation vs. patients requiring salvage laryngectomies. VIII. Compare the quality of life of patients receiving radiotherapy alone vs. those receiving chemotherapy as well.
OUTLINE: Randomized study. Patients on any arm, clinically staged N+ undergo neck dissection following completion of radiotherapy. Arm I: 2-Drug Combination Chemotherapy followed by Radiotherapy. Cisplatin, CDDP, NSC-119875; Fluorouracil, 5-FU, NSC-19893; followed by regional irradiation using linear accelerators with photon energies of 1.25-6 MV, electron energies of 8-17 MeV, or Co60. Arm II: Radiotherapy plus Single-Agent Chemotherapy/Radiosensitization. Regional irradiation using equipment as in Arm I; plus CDDP. Arm III: Radiotherapy. Regional irradiation using equipment as in Arm I.
PROJECTED ACCRUAL: 546 patients (182/arm) will be entered over approximately 3 years. If any arm is clearly inferior in laryngectomy-free survival after 137 patients have completed 2 years of follow-up study, that arm will be closed to further accrual. A second interim analysis will be conducted after 410 patients have completed 2 years of follow-up.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||PHASE III TRIAL TO PRESERVE THE LARYNX: INDUCTION CHEMOTHERAPY AND RADIATION THERAPY VERSUS CONCOMITANT CHEMOTHERAPY AND RADIATION THERAPY VERSUS RADIATION THERAPY|
|Study Start Date :||August 1992|
|Actual Primary Completion Date :||August 2002|
|Actual Study Completion Date :||November 2013|
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): NCT00002496
|Study Chair:||Helmuth Goepfert, MD||M.D. Anderson Cancer Center|
|Study Chair:||George L. Adams, MD||Masonic Cancer Center, University of Minnesota|
|Study Chair:||David E. Schuller, MD||Ohio State University Comprehensive Cancer Center|