Radiation Therapy in Treating Patients With Head and Neck Cancer

United Kingdom Research and Innovation (UKRI)

Status and phase: Completed; Phase 3

Conditions: Head and Neck Cancer; Non-melanomatous Skin Cancer

Treatments: Procedure: adjuvant therapy; Radiation: radiation therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00021125

CDR0000068750 (Registry Identifier)

MRC-CH03

EU-20121

ISRCTN62576956

Details and patient eligibility

About

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.

Full 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.

Enrollment: 460 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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