Phase III Randomized Trial of Image Guided Intensity Modulated Radiotherapy (IG-IMRT) and Conventional Radiotherapy for Late Toxicity Reduction After Postoperative Radiotherapy in Ca Cervix.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Late bowel toxicity ≥ Grade II
研究概览
简要总结
The study tests Tomtherapy based Image Guided Radiation against conventional radiation techniques for it's ability to reduce long term small bowel toxicity.
详细描述
Postoperative pelvic radiotherapy (+/- chemotherapy) leads to reduction in the risk of local recurrence and improves progression free survival (PFS) in patients with post-operative intermediate and high risk factors following Wertheim's hysterectomy. However, adjuvant external beam radiotherapy and vaginal cuff brachytherapy increase the risk of small bowel toxicity such that patients undergoing external beam pelvic radiotherapy and vaginal cuff brachytherapy may have 15-18% incidence of late RTOG ≥ grade II small bowel toxicity. Phase II studies using new techniques like Intensity Modulated Radiotherapy (IMRT) have reported up to 50% reduction in small bowel doses with up to 30% reduction in ≥ grade II acute toxicity. However, there is no randomized data demonstrating the benefit of highly specific and conformal techniques like image guided (IG)-IMRT in reducing radiation induced small bowel toxicity in patients with cervical cancers. The present study is being proposed to test if use of IG-IMRT with Tomotherapy is associated with reduced small bowel late toxicity
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
盲法说明
No masking. This is a open-label study.
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
- •Histopathological diagnosis of carcinoma cervix with postoperative intermediate or high risk features.
- •Age >18 years.
- •Planned for Wertheim's hysterectomy or has already undergone Wertheim's hysterectomy OR has undergone Simple Hysterectomy with no evidence of residual nodes on MRI/PET imaging+/- confirmatory nodal biopsy.
- •No evidence of paraaortic nodal metastasis.
排除标准
- •History of multiple previous abdominal surgeries placing patient at baseline high risk of bowel toxicity or any other medical condition with baseline bowel movement disorder.
- •Rectal Polyps or extensive hemorrhoids.
研究组 & 干预措施
Conventional RT
Patients in this arm will receive conventional radiation with or without chemotherapy
干预措施: Conventional Radiation (Radiation)
Tomotherapy based IGRT
Patients in this arm will receive Tomotherapy based IGRT with or without chemotherapy
干预措施: Tomotherapy based IGRT (Radiation)
结局指标
主要结局
Late bowel toxicity ≥ Grade II
时间窗: Median follow up of 3 years
Time to event and severity of late bowel toxicity are assessed
次要结局
- To identify small bowel dose volume characteristics that predict for ≥ Grade II late toxicity(Median follow up of 3 years)
- To compare quality of life between Tomotherapy vs conventional radiotherapy arm using EORTC QLQ CX24(3 years from completion of accrual)
- To evaluate acute toxicity difference in two study arms using CTCAE version 3.0(Within 90 days)
- Preoperative functional imaging features that predict for local and distant recurrence will be identified(3 years after completion of accrual)
- To compare quality of life between Tomotherapy vs conventional radiotherapy arm using EORTC QLQ C30(3 years from completion of accrual)
研究者
Supriya Sastri (chopra)
Associate Professor
Tata Memorial Hospital