Radiation Therapy With or Without Chemotherapy in Treating Patients With Advanced Cancer of the Larynx

Last updated: January 23, 2014
Sponsor: Radiation Therapy Oncology Group
Overall Status: Completed

Phase

3

Condition

Head And Neck Cancer

Nasopharyngeal Cancer

Human Papilloma Virus (Hpv)

Treatment

N/A

Clinical Study ID

NCT00002496
RTOG-9111
SWOG-9201
EST-R9111
CDR0000077756
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

DISEASE CHARACTERISTICS: Biopsy-proven, previously untreated, squamous cell carcinoma of the glottic and supraglottic larynx that would normally require total laryngectomy Stage III/IV disease (excluding T1 and M1) Endoscopic tumor staging required within 4 weeks of entry Tumors must be considered resectable and potentially curable with conventional surgery and radiotherapy T4 disease limited to: Up to 1 cm invasion of the base of tongue Questionable cartilage invasion on CT (clinically T3) Measurable disease required No synchronous primary tumors No subglottic tumors

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60%-100% Hematopoietic: (obtained within 3 weeks of entry) WBC at least 3,500 Platelets at least 100,000 Hepatic: Not specified Renal: (obtained within 2 weeks of entry) Creatinine clearance at least 50 mL/min (measured or calculated) Serum calcium normal Cardiovascular: Status adequate to tolerate all protocol therapy Pulmonary: Status adequate to tolerate all protocol therapy Other: Nutritional status adequate to tolerate all protocol therapy Mental status adequate to follow instructions and keep appointments No second malignancy except nonmelanomatous skin cancer (Patients who have been disease-free for at least 3 years following treatment for a prior cancer may be eligible at the discretion of the protocol chairman) Negative pregnancy test required of fertile women Effective contraception required of fertile women

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior therapy Chemotherapy: No prior therapy Endocrine therapy: No prior therapy Radiotherapy: No prior radiotherapy to the head and neck Surgery: No prior therapy

Study Design

Study Start date:
August 01, 1992
Estimated Completion Date:
November 30, 2013

Study Description

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.

Connect with a study center

  • Pretoria Academic Hospital

    Pretoria, 0001
    South Africa

    Site Not Available

  • CCOP - Colorado Cancer Research Program, Inc.

    Denver, Colorado 80209-5031
    United States

    Site Not Available

  • H. Lee Moffitt Cancer Center and Research Institute

    Tampa, Florida 33612
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Atlanta (Decatur)

    Decatur, Georgia 30033
    United States

    Site Not Available

  • CCOP - Illinois Oncology Research Association

    Peoria, Illinois 61602
    United States

    Site Not Available

  • CCOP - Carle Cancer Center

    Urbana, Illinois 61801
    United States

    Site Not Available

  • Indiana University Cancer Center

    Indianapolis, Indiana 46202-5265
    United States

    Site Not Available

  • Veterans Affairs Medical Center - Indianapolis (Roudebush)

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • CCOP - Iowa Oncology Research Association

    Des Moines, Iowa 50309-1016
    United States

    Site Not Available

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts 02215
    United States

    Site Not Available

  • New England Medical Center Hospital

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • CCOP - Kalamazoo

    Kalamazoo, Michigan 49007-3731
    United States

    Site Not Available

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota 55416
    United States

    Site Not Available

  • Veterans Affairs Medical Center - East Orange

    East Orange, New Jersey 07018-1095
    United States

    Site Not Available

  • CCOP - Northern New Jersey

    Hackensack, New Jersey 07601
    United States

    Site Not Available

  • Ireland Cancer Center

    Cleveland, Ohio 44106-5065
    United States

    Site Not Available

  • Hahnemann University Hospital

    Philadelphia, Pennsylvania 19102-1192
    United States

    Site Not Available

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

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