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 if radiation therapy plus chemotherapy 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 high-dose radiation therapy alone with high-dose radiation therapy plus cisplatin in treating patients with head and neck cancer who have undergone surgery to remove the cancer.

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

Further Study Details: 

OBJECTIVES: I. Determine whether the addition of cisplatin to high-dose postoperative radiotherapy increases the disease-free survival rate of patients with locally advanced head and neck carcinomas at high risk of recurrence following radical surgery.

PROTOCOL OUTLINE: Randomized study. Patients are registered and randomized to treatment within 25 days of surgery. Arm I: Radiotherapy. Irradiation of the preoperative primary tumor site with a boost to areas at high risk for recurrence using Co60 equipment, 4-6 MV linear accelerators, or 6-12 MeV electrons. Arm II: Radiotherapy plus Single-Agent Chemotherapy. Irradiation as in Arm I; plus Cisplatin, CDDP, NSC-119875.

PROJECTED ACCRUAL: A total of 338 evaluable patients will be studied.

Ages Eligible for Study:  18 Years   -   70 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Histologically confirmed squamous cell carcinoma of the head and neck of the following sites: Oral cavity; Oropharynx; Hypopharynx (only if ineligible for protocol EORTC-24891); Larynx
• T3-4, any N, M0 or any T, N2-3, M0 disease (UICC staging) resected with curative intent T3, N0 carcinoma of the larynx with suitable microscopically clear margins is ineligible
• At least one of the following high-risk characteristics required: Histopathologically positive surgical margins; No gross residual disease; Perineural involvement; Extranodal spread of disease; Oral cavity or oropharyngeal lesions with metastatic nodes at level 4 or 5; Vascular embolisms in the neck
• No metastases at diagnosis
• No known CNS disease

--Prior/Concurrent Therapy--

• Biologic therapy: Not specified
• Chemotherapy: No prior chemotherapy
• Endocrine therapy: Not specified
• Radiotherapy: No prior locoregional radiotherapy to the head and neck
• Surgery: Excision with curative intent required

--Patient Characteristics--

• Age: 18 to 70
• Performance status: WHO 0-2
• Hematopoietic: WBC at least 4,000; Platelets at least 100,000; Hemoglobin normal (at least 6.8 mmoles/liter)
• Hepatic: Bilirubin no greater than 2 times normal; Other liver function tests no greater than 2 times normal
• Renal: Creatinine no greater than 1.3 mg/dL (120 micromoles/liter); Creatinine clearance greater than 60 mL/min
• Other: No active, uncontrolled infection; No requirement for antibiotics that might interfere with platinum excretion; No requirement for drugs affecting bone marrow function (e.g., lithium, corticosteroids); No medical condition precluding postoperative chemotherapy; No prior or concurrent malignancy other than nonmelanomatous skin cancer

Belgium
      Institut Jules Bordet, Brussels,  1000,  Belgium
France
      Centre de Lute Contre le Cancer,Georges-Francois Leclerc, Dijon,  21079,  France
      Centre Oscar Lambret, Lille,  59020,  France
      CHR de Grenoble - La Tronche, Grenoble,  38043,  France
      CRLCC Nantes - Atlantique, Nantes-Saint Herblain,  44805,  France
      Hopital Jean Bernard, Poitiers,  86021,  France
      Institut Gustave Roussy, Villejuif,  F-94805,  France
Italy
      Istituti Fisioterapici Ospitalieri - Roma, Rome,  00161,  Italy
      Istituto Nazionale per lo Studio e la Cura dei Tumori, Milan,  20133,  Italy
Netherlands
      University Medical Center Nijmegen, Nijmegen,  NL-6252 HB,  Netherlands
Poland
      Medical University of Gdansk, Gdansk,  80-211,  Poland
Slovenia
      Institute of Oncology, Ljubljana, LJUBLJANA,  Sl-1000,  Slovenia
Spain
      Ciudad Sanitaria Vall D'Hebron, Barcelona,  08035,  Spain
Switzerland
      Centre Hospitalier Universitaire Vaudois, Lausanne,  CH-1011,  Switzerland
      Inselspital, Bern, Bern,  CH-3010,  Switzerland
      Ospedale San Giovanni, Bellinzona,  CH-6500,  Switzerland
      Universitaetsspital, Zurich,  CH-8091,  Switzerland
Turkey
      Dokuz Eylul University School of Medicine, Izmir,  35340,  Turkey
United Kingdom, England
      Nottingham City Hospital NHS Trust, Nottingham,  England,  NG5 1PB,  United Kingdom

Study chairs or principal investigators

Jacques Bernier,  Study Chair,  EORTC Radiotherapy Cooperative Group   

Study ID Numbers:  CDR0000063431; EORTC-22931
Record last reviewed:  May 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00002555
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08