Radiation Therapy in Treating Patients With Head and Neck Cancer
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|ClinicalTrials.gov Identifier: NCT00021125|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 26, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer Non-melanomatous Skin Cancer||Procedure: adjuvant therapy Radiation: radiation therapy||Phase 3|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||460 participants|
|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|
|Study Start Date :||July 2000|
|Study Completion Date :||June 2007|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00021125
|Mount Vernon Cancer Centre at Mount Vernon Hospital|
|Northwood, England, United Kingdom, HA6 2RN|
|Study Chair:||M. I. Saunders, MD||Mount Vernon Cancer Centre at Mount Vernon Hospital|