High-Dose Radiation Therapy With or Without Chemotherapy in Treating Patients With Head and Neck Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Head and Neck Cancer Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institut Jules Bordet, Brussels, Belgium

About this study

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.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

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

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

Treatment and study plan

Cisplatin

Drug

low-LET cobalt-60 gamma ray therapy

Radiation

low-LET electron therapy

Radiation

low-LET photon therapy

Radiation

Sponsors and collaborators

Lead sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Network

Registry information

Official study title

A PHASE III RANDOMIZED STUDY ON POSTOPERATIVE RADIO- AND CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED HEAD AND NECK CARCINOMAS

Important dates

Study start: 1994
Primary completion: 2000
First posted: May 26, 2004
Registry last updated: Jul 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed