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

Alternate Title

Radiation Therapy in Treating Patients With Head and Neck Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase III Treatment Completed Not specified Other MRC-CH03 EU-20121, ISRCTN62576956, NCT00021125

Objectives

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

Entry 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

Prior/Concurrent Therapy:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics

Surgery

• See Disease Characteristics

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

Expected Enrollment

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

Outcomes

Time to local recurrence

Length of survival
Morbidity and toxicity
Quality of life as assessed by EORTC Quality of life Questionnaire for Head and Neck Cancer

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.

Trial Contact Information

Trial Lead Organizations

Medical Research Council Clinical Trials Unit

M. I. Saunders, MD, Protocol chair		Ph: 44-1923-844-533 Email: michele_saunders@hotmail.com

Registry Information
Official Title		A Randomized Controlled Trial Of CHARTWEL (a continuous Hyperfractionated Accelerated Radiotherapy Schedule) Versus Conventional Radiotherapy In Post-Operative Head And Neck Cancer Patients
Trial Start Date		2000-07-01
Registered in ClinicalTrials.gov		NCT00021125
Date Submitted to PDQ		2001-05-16
Information Last Verified		2002-12-04

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