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

Head and Neck Cancer Clinical Trial

Official title:

Surgery and Adjuvant Radiotherapy Versus Concurrent Chemo-Radiotherapy for Resectable (Non-Metastatic) Stage III/IV Head and Neck Squamous Cell Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00003576
• Other study ID #: CDR0000066643
• Secondary ID: NMRC-SHN01EU-970
• Status: Completed
• Phase: Phase 3
• First received: November 1, 1999
• Last updated: December 18, 2013
• Start date: January 1997
• Est. completion date: August 2005

Study information

• Verified date: April 2007
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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 surgery plus radiation therapy is more effective than chemotherapy plus radiation therapy for head and neck cancer.

PURPOSE: This randomized phase III trial is studying surgery and radiation therapy to see how well they work compared to chemotherapy and radiation therapy in treating patients with stage III or stage IV head and neck cancer that can be removed during surgery.

Description:

OBJECTIVES:

• 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.

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• ECOG 0-1

Life expectancy:

• Not specified

Hematopoietic:

• WBC greater than 3000/mm^3

• Platelet count greater than 100,000/mm^3

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

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)

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Drug:
• cisplatin

• fluorouracil

Procedure:
• surgical procedure

Radiation:
• radiation therapy

Locations

Country	Name	City	State
Singapore	National Cancer Centre - Singapore	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Centre, Singapore

Country where clinical trial is conducted

Singapore, 

References & Publications (1)

Soo KC, Tan EH, Wee J, Lim D, Tai BC, Khoo ML, Goh C, Leong SS, Tan T, Fong KW, Lu P, See A, Machin D. Surgery and adjuvant radiotherapy vs concurrent chemoradiotherapy in stage III/IV nonmetastatic squamous cell head and neck cancer: a randomised compari — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response at 6 weeks after completion of study treatment			No
Primary	Disease-free survival			No
Primary	Overall survival			No