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	Treatment or Intervention	Phase
stage IV squamous cell carcinoma of the lip and oral cavity stage II squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the hypopharynx stage II squamous cell carcinoma of the oropharynx stage III squamous cell carcinoma of the larynx stage IV squamous cell carcinoma of the larynx stage II squamous cell carcinoma of the larynx stage III squamous cell carcinoma of the lip and oral cavity stage III squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the hypopharynx stage II squamous cell carcinoma of the hypopharynx	Drug: cisplatin	Phase III

Further Study Details: 

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.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Biopsy-proven squamous cell carcinoma of one of the following sites: Hypopharynx; Larynx; Oral cavity; Oropharynx
• At least 1 of the following high-risk factors required: Histologic extracapsular nodal extension; Histologic involvement of 2 or more regional lymph nodes; Microscopically positive mucosal margins
• Complete resection of all visible and palpable disease; Therapy must begin within 8 weeks of tumor-related surgery; Bilateral resections may or may not be performed simultaneously; Eligibility window begins with first definitive surgery; Neck dissection not required for T4 N0, truly midline supraglottic tumors
• No tumors of the lip, nasopharynx, or sinuses
• No synchronous or concurrent head and neck tumors
• No evidence of distant metastasis
• Concurrent registration on Fixed Tumor Repository Study allowed

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior chemotherapy
• Endocrine therapy: Not specified
• Radiotherapy: No prior radiotherapy to head and neck region
• Surgery: See Disease Characteristics

--Patient Characteristics--

• Age: 18 and over

Performance status: Karnofsky 60%-100%

• Hematopoietic: WBC at least 3,500; Platelets at least 100,000
• Hepatic: Not specified
• Renal: Creatinine clearance greater than 50 mL/min
• Other: No medical contraindication to protocol therapy; No second malignancy within 5 years; No pregnant or nursing women

Florida
      H. Lee Moffitt Cancer Center and Research Institute, Tampa,  Florida,  33612,  United States
Georgia
      Emory University Hospital - Atlanta, Atlanta,  Georgia,  30322,  United States
      Veterans Affairs Medical Center - Atlanta (Decatur), Decatur,  Georgia,  30033,  United States
Illinois
      CCOP - Carle Cancer Center, Urbana,  Illinois,  61801,  United States
      CCOP - Evanston, Evanston,  Illinois,  60201,  United States
      CCOP - Illinois Oncology Research Association, Peoria,  Illinois,  61602,  United States
Indiana
      Indiana University Cancer Center, Indianapolis,  Indiana,  46202-5265,  United States
Iowa
      CCOP - Cedar Rapids Oncology Project, Cedar Rapids,  Iowa,  52403-1206,  United States
      CCOP - Iowa Oncology Research Association, Des Moines,  Iowa,  50309-1016,  United States
Michigan
      CCOP - Kalamazoo, Kalamazoo,  Michigan,  49007-3731,  United States
Minnesota
      CCOP - Duluth, Duluth,  Minnesota,  55805,  United States
      CCOP - Metro-Minnesota, Saint Louis Park,  Minnesota,  55416,  United States
      University of Minnesota Cancer Center, Minneapolis,  Minnesota,  55455,  United States
Nebraska
      CCOP - Missouri Valley Cancer Consortium, Omaha,  Nebraska,  68131,  United States
New Jersey
      CCOP - Northern New Jersey, Hackensack,  New Jersey,  07601,  United States
Ohio
      CCOP - Toledo Community Hospital Oncology Program, Toledo,  Ohio,  43623-3456,  United States
      Ireland Cancer Center, Cleveland,  Ohio,  44106-5065,  United States
Oklahoma
      CCOP - Sooner State, Tulsa,  Oklahoma,  74136,  United States
Tennessee
      Vanderbilt Cancer Center, Nashville,  Tennessee,  37232-6838,  United States
      Veterans Affairs Medical Center - Nashville, Nashville,  Tennessee,  37212,  United States
Wisconsin
      Medical College of Wisconsin, Milwaukee,  Wisconsin,  53226,  United States
      Veterans Affairs Medical Center - Milwaukee (Zablocki), Milwaukee,  Wisconsin,  53295,  United States
South Africa
      Pretoria Academic Hospital, Pretoria,  0001,  South Africa

Study chairs or principal investigators

Walter John Curran, Jr.,  Study Chair,  Radiation Therapy Oncology Group   
James N. Endicott,  Study Chair
Charles A. Coltman, Jr.,  Study Chair

Study ID Numbers:  CDR0000064279; RTOG-9501; E-R9501; SWOG-9515
Record last reviewed:  June 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002670
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08