NCT00021125已完成3 期
A Randomized Controlled Trial Of CHARTWEL (a Continuous Hyperfractionated Accelerated Radiotherapy Schedule) Versus Conventional Radiotherapy In Post-Operative Head And Neck Cancer Patients
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 460
- 试验地点
- 2
- 主要终点
- Time to local recurrence
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Histologically confirmed squamous cell carcinoma of the head and neck including, but not limited to, the following:
- •Oral cavity
- •Oropharynx
- •Hypopharynx
- •Nasal sinuses
- •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:
- •Not specified
- •Performance status:
- •Not specified
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Not specified
- •Not specified
- •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
- •See Disease Characteristics
排除标准
- 未提供
结局指标
主要结局
Time to local recurrence
次要结局
- Length of survival
- Morbidity and toxicity
- Quality of life as assessed by EORTC Quality of life Questionnaire for Head and Neck Cancer
研究者
研究点 (2)
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