Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information
Radiation Therapy in Treating Patients With Head and Neck Cancer
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Treatment | Completed | Not specified | Other | MRC-CH03 EU-20121, ISRCTN62576956, NCT00021125 |
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.
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
460A total of 460 patients (230 per arm) will be accrued for this study within 2-3 years.
Outcomes
Primary Outcome(s)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 Lead Organizations
Medical Research Council Clinical Trials Unit
 | | | ||
| M. I. Saunders, MD, Protocol chair | |
| ||
| ||||
| 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 | |
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| Trial Start Date | 2000-07-01 | |
| ||
| Registered in ClinicalTrials.gov | NCT00021125 | |
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| Date Submitted to PDQ | 2001-05-16 | |
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| Information Last Verified | 2002-12-04 | |
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.
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