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


Phase 3
18 Years
70 Years
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

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


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.

Inclusion 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

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Jacques Bernier, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Istituto Oncologico della Svizzera Italiana - Ospedale San Giovanni

Authority:

United States: Federal Government

Study ID:

EORTC-22931

NCT ID:

NCT00002555

Start Date:

February 1994

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • 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
  • Head and Neck Neoplasms

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