HDR Brachytherapy Combined With Interstitial Hyperthermia 500 kHz in Locally Advanced Cervical Cancer Patients. A Prospective Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- LC
研究概览
简要总结
The aim of this randomised trial was to investigate whether hyperthermia (HT) combined with interstitial brachytherapy (ISBT) has any influence on local control (LC), disease-free survival (DFS), or acute and late side effects in patients with advanced cervical cancer. Vaginal symptoms were assessed by SOMA score, bladder and rectum symptoms by EORTC/RTOG score. Following the completion of radiochemotherapy, consecutive patients with cervical cancer (FIGO stage II - III) were randomly assigned to two treatment groups, either ISBT alone or ISBT combined with interstitial hyperthermia (ISHT). A total of 205 patients were included in the statistical analysis. Once a week, HT, at a temperature above 42.5°C, was administered for 45 minutes before and during the HDR BT. Follow-up examinations were scheduled at 6 weeks after the completion of BT, every 3 months during the first 2 years, and every 6 months throughout the next 3 years. If relapse was suspected, biopsies were obtained from these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients with locally advanced cervical cancer FIGO stage II - III
- •signed informed consent for participation in the study
排除标准
- •patients with FIGO stage I and IV
- •patients with poor performance status with contraindications for radical treatments
研究组 & 干预措施
BT (brachytherapy)
Cervical cancer patients after the treatment with external beam radiotherapy combined with chemotherapy. In this group of patients, interstitial brachytherapy only was performed.
干预措施: hyperthermia (Other)
BTHT (brachytherapy and hyperthermia)
Cervical cancer patients after the treatment with external beam radiotherapy combined with chemotherapy. In this group of patients, interstitial brachytherapy with interstitial hyperthermia was performed.
干预措施: hyperthermia (Other)
结局指标
主要结局
LC
时间窗: Follow up was scheduled every 3 months. Preliminary results after 3 years.
When local relapse was suspected, biopsy was obtained.
次要结局
- Late side effects(Follow up was scheduled every 3 months. Preliminary results after 3 years.)
- Early complications of BT procedure(24 hours after BT procedure)
- DFS(Follow up was scheduled every 3 months. Preliminary results after 3 years.)