A Randomized Controlled Trial Of CHARTWEL (a Continuous Hyperfractionated Accelerated Radiotherapy Schedule) Versus Conventional Radiotherapy In Post-Operative Head And Neck Cancer Patients
N/A
N/A
Both
Head and Neck Cancer, Non-melanomatous Skin Cancer
Trial Information
A Randomized Controlled Trial Of CHARTWEL (a Continuous Hyperfractionated Accelerated Radiotherapy Schedule) Versus Conventional Radiotherapy In Post-Operative Head And Neck Cancer Patients
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.
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Outcome Measure:
Time to local recurrence
Safety Issue:
No
Principal Investigator
M. I. Saunders, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Mount Vernon Cancer Centre at Mount Vernon Hospital
Authority:
United States: Federal Government
Study ID:
MRC-CH03
NCT ID:
NCT00021125
Start Date:
July 2000
Completion Date:
June 2007
Related Keywords:
- Head and Neck Cancer
- Non-melanomatous Skin Cancer
- squamous cell carcinoma of the skin
- stage I squamous cell carcinoma of the lip and oral cavity
- stage II squamous cell carcinoma of the lip and oral cavity
- stage III squamous cell carcinoma of the lip and oral cavity
- stage IV squamous cell carcinoma of the lip and oral cavity
- stage I squamous cell carcinoma of the oropharynx
- stage II squamous cell carcinoma of the oropharynx
- stage III squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- stage I squamous cell carcinoma of the hypopharynx
- stage II squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- stage I squamous cell carcinoma of the larynx
- stage II squamous cell carcinoma of the larynx
- stage III squamous cell carcinoma of the larynx
- stage IV squamous cell carcinoma of the larynx
- stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage III squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
- salivary gland squamous cell carcinoma
- stage I salivary gland cancer
- stage II salivary gland cancer
- stage III salivary gland cancer
- stage IV salivary gland cancer
- Skin Neoplasms
- Head and Neck Neoplasms
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