Radiation Therapy in Treating Patients With Head and Neck Cancer

NCT ID: NCT00021125

Last Updated: 2013-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 460 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-07-31
• Study Completion Date: 2007-06-30

Brief Summary

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet known which regimen of radiation therapy is more effective for head and neck cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of radiation therapy in treating patients who have head and neck cancer.

Detailed Description

OBJECTIVES:

• Compare adjuvant continuous hyperfractionated accelerated radiotherapy vs conventional radiotherapy, in terms of preventing disease recurrence, in patients with head and neck cancer.
• Compare the early and late toxic effects of these treatments in this patient population.
• Compare disease-free and overall survival of patients receiving these treatments.
• Assess quality of life in patients receiving these treatments.

OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms.

• Arm I: Patients undergo radiotherapy 3 times daily, with an interval of at least 6 hours between any 2 treatments, 5 days a week, for just over 2 weeks, for a total of 13-14 treatment days.
• Arm II: Patients undergo radiotherapy daily, 5 days a week, for 6-6.5 weeks. Quality of life is assessed at baseline and then annually for 5 years.

Patients are followed every 3 months for 3 years, every 6 months for 2 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 460 patients (230 per arm) will be accrued for this study within 2-3 years.

Conditions

Head and Neck Cancer; Non-melanomatous Skin Cancer

Study Design

• Primary Study Purpose: TREATMENT

Interventions

adjuvant therapy

Intervention Type: PROCEDURE

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed squamous cell carcinoma of the head and neck including, but not limited to, the following:

• Oral cavity
• Oropharynx
• Hypopharynx
• Larynx
• Nasal sinuses
• Skin
• Undergone curative surgery within the past 70 days

• All macroscopic disease removed
• At high or intermediate risk of recurrence

• No low risk of recurrence
• No evidence of distant metastases
• Considered treatable by radiotherapy

PATIENT CHARACTERISTICS:

Age:

• Not specified

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Not specified

Other:

• No other prior or concurrent malignancy that would preclude study participation
• No other uncontrolled medical illness that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

Surgery

• See Disease Characteristics

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical Research Council

OTHER_GOV

Sponsor Role: lead

Principal Investigators

M. I. Saunders, MD

Role: STUDY_CHAIR

Mount Vernon Cancer Centre at Mount Vernon Hospital

Locations

Mount Vernon Cancer Centre at Mount Vernon Hospital

Northwood, England, United Kingdom

Countries

United Kingdom

Other Identifiers

CDR0000068750

Identifier Type: REGISTRY

Identifier Source: secondary_id

EU-20121

Identifier Type: -

Identifier Source: secondary_id

ISRCTN62576956

Identifier Type: -

Identifier Source: secondary_id

MRC-CH03

Identifier Type: -

Identifier Source: org_study_id