External Beam Radiotherapy for Pelvic Recurrences in Rectal Cancer Patients Previously Treated With Radiotherapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Resection rate
研究概览
简要总结
This study investigates the potential benefit of re-irradiation of patients with locally advanced rectal recurrences, by a prospective phase II clinical, imaging and translational research study.
详细描述
The overall purpose of this trial is to evaluate the efficacy of re-irradiation of patients with locally advanced rectal cancer (LRRC) recurrences who previously received pelvic irradiation. Patients with potentially resectable LRRC will be treated with hyperfractionated Intensity-Modulated Radiotherapy consisting of 40.8 Gy in 1.2 fractions twice daily with concomitant oral capecitabine followed by surgery, when feasible.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Locally recurrent rectal cancer
- •Previous pelvic RT for rectal cancer and surgery
- •Potentially resectable by MRI and palpation by MDT evaluation
- •Absence of non-resectable distant metastases by PET-CT
- •Adequate organ function
- •Acceptable bowel and bladder function
- •Acceptance for TR sampling
排除标准
- •Central small recurrences deemed immediate resectable
- •Previous radiotherapy <12 month prior to recurrence
- •Non-resectable systemic or regional disease
- •Unable to undergo MRI or PET-CT
- •Medical comorbidities precluding radical surgery
结局指标
主要结局
Resection rate
时间窗: At surgery
Rate of complete pathological resection R0
次要结局
- Physician reported Toxicity(Acute and late toxicity evaluations during and at 6,12 and 36 months post surgery)
- QoL assessment according to QLQ-CR29(Pre-treatment and 12 months post surgery)
- Comparative dose planning study(The VMAT plans generated before treatment start (baseline) is compared to IMPT plans.)
- QoL assessment according to EORTC QLQ-C30(Pre-treatment and 12 months post surgery)
- Recurrence rate(Rate of re-recurrence at 6, 12 and 36 months post surgery.)
研究者
Karen-Lise Garm Spindler
Associate Professor
Aarhus University Hospital