Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

Surgery and Radiation Therapy Compared With Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Head and Neck Cancer That Can Be Removed During Surgery

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Closed Not specified Other NMRC-SHN01 EU-97015, NCT00003576

Objectives

1. Compare the complete response rate, disease-free survival, and overall survival of patients with resectable (nonmetastatic) stage III or IV squamous cell cancer of the head and neck treated with surgery and adjuvant radiotherapy versus concurrent chemo-radiotherapy.

Entry Criteria

Disease Characteristics:

• Histologically confirmed head and neck squamous cell cancer (excluding nasopharynx and salivary glands) on biopsy of the primary lesion or the neck mass



• Stage III or IV disease
  • No evidence of distant or systemic metastases



• Resectable disease

Prior/Concurrent Therapy:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• No prior radiotherapy to the head and neck

Surgery:

• See Disease Characteristics
• No prior surgery (other than biopsy)

Patient Characteristics:

Age:

• Not specified

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 3000/mm³
• Platelet count greater than 100,000/mm³

Hepatic:

• SGOT less than 2 times upper limit of normal
• Bilirubin less than 1.4 mg/dL

Renal:

• Creatinine less than 1.6 mg/dL

Other:

• No prior or concurrent primary malignancies
• Not pregnant
• Fertile patients must use effective contraception

Expected Enrollment

Approximately 200 patients will be accrued over a 4-5 year period.

Outcomes

Response at 6 weeks after completion of study treatment
Disease-free survival
Overall survival

Outline

This is a randomized study. Patients are stratified according to primary site of disease (oral cavity/oropharynx vs larynx/hypopharynx vs others) and nodal status (node negative vs positive).

• Arm I: Patients undergo resection of the tumor, followed no more than 6 weeks later by radiotherapy to the primary tumor and upper neck once a day, 5 days a week, for 6 weeks.



• Arm II: Patients undergo radiotherapy in addition to chemotherapy with fluorouracil and cisplatin. Radiotherapy is given once a day, 5 days a week, for 6.5 weeks to the primary tumor and upper neck. Fluorouracil and cisplatin are administered by continuous infusion for 4 days beginning on day 1 of the first week of radiotherapy. A second course of fluorouracil and cisplatin is given on day 28.

Patients who have failed or are suspected to have failed chemo-radiotherapy should be considered for salvage surgery.

Patients are followed once a month for the first year, every 2 months for the second year, every 3 months for the third year, and every 6 months thereafter.

Soo KC, Tan EH, Wee J, et al.: Surgery and adjuvant radiotherapy vs concurrent chemoradiotherapy in stage III/IV nonmetastatic squamous cell head and neck cancer: a randomised comparison. Br J Cancer 93 (3): 279-86, 2005.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

NCC Head and Neck Clinic

Soo Khee Chee, MD, Protocol chair		Ph: 65-436-8205 Email: admskc@nccs.com.sg

Registry Information
Official Title		Surgery and Adjuvant Radiotherapy Versus Concurrent Chemo-Radiotherapy for Resectable (Non-Metastatic) Stage III/IV Head and Neck Squamous Cell Cancer
Trial Start Date		1997-01-01
Registered in ClinicalTrials.gov		NCT00003576
Date Submitted to PDQ		1998-09-14
Information Last Verified		2007-04-11

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