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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00002496
Recruitment Status : Completed
First Posted : June 9, 2004
Last Update Posted : January 24, 2014
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Southwest Oncology Group
Information provided by (Responsible Party):
Radiation Therapy Oncology Group

Brief 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.

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

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Study Start Date : August 1992
Actual Primary Completion Date : August 2002
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT00002496

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United States, Colorado
CCOP - Colorado Cancer Research Program, Inc.
Denver, Colorado, United States, 80209-5031
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612
United States, Georgia
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, United States, 30033
United States, Illinois
CCOP - Illinois Oncology Research Association
Peoria, Illinois, United States, 61602
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Indiana University Cancer Center
Indianapolis, Indiana, United States, 46202-5265
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis, Indiana, United States, 46202
United States, Iowa
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, United States, 50309-1016
United States, Massachusetts
New England Medical Center Hospital
Boston, Massachusetts, United States, 02111
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
United States, Michigan
CCOP - Kalamazoo
Kalamazoo, Michigan, United States, 49007-3731
United States, Minnesota
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
United States, New Jersey
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07018-1095
CCOP - Northern New Jersey
Hackensack, New Jersey, United States, 07601
United States, Ohio
Ireland Cancer Center
Cleveland, Ohio, United States, 44106-5065
United States, Pennsylvania
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102-1192
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States, 15213
South Africa
Pretoria Academic Hospital
Pretoria, South Africa, 0001
Sponsors and Collaborators
Radiation Therapy Oncology Group
National Cancer Institute (NCI)
Eastern Cooperative Oncology Group
Southwest Oncology Group
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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

Publications of Results:
Other Publications:
Konski A, Bhargavan M, Owen J, et al.: The price of failure: economic analysis of recurrence and complications of patients treated on RTOG 91-11. [Abstract] The American Radium Society 89th Annual Meeting, May 5-29, 2007, Amsterdam, Netherlands. A-SS-6, 3, 2007.
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.
Konski AA, Bhargavan M, Owen J, et al.: The addition of chemotherapy to radiation is cost-effective in the treatment of patients with locally advanced laryngeal cancer: an economic analysis of Radiation Therapy Oncology Group (RTOG) 91-11. [Abstract] Int J Radiat Oncol Biol Phys 66 (3 Suppl 1): A-115, S66, 2006.
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.
Bourhis J, Amand C, Pignon JP, et al.: Update of MACH-NC (Meta-Analysis of Chemotherapy In Head & Neck Cancer ) database focused on concomitant chemotherapy. [Abstract] J Clin Oncol 12 (Suppl 14): A-5505, 489s, 2004.
Konski AA, Pajak T, Movsas B, et al.: Socio-demographic variables influence outcome in Radiation Therapy Oncology Group head and neck trials. [Abstract] Proceedings of the American Society of Clinical Oncology 22 (Suppl 14): A-6043, 529s, 2004.
Movsas B, Konski A, Pajak T, et al.: Quality of life (QOL) variables influence local regional control in Radiation Therapy Oncology Group (RTOG) headsneck trials (9003 and 9111). [Abstract] Int J Radiat Oncol Biol Phys 60 (1 Suppl 1): A-199, S252, 2004.

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Responsible Party: Radiation Therapy Oncology Group Identifier: NCT00002496     History of Changes
Other Study ID Numbers: RTOG-9111
First Posted: June 9, 2004    Key Record Dates
Last Update Posted: January 24, 2014
Last Verified: January 2014

Keywords provided by Radiation Therapy Oncology Group:
stage III squamous cell carcinoma of the larynx
stage IV squamous cell carcinoma of the larynx

Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms by Site
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs