Randomized Trial of Preoperative Radiotherapy With an Integrated Simultaneous Boost Compared to Chemoradiotherapy for T3-4 Rectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- reduction in metabolic tumor activity
研究概览
简要总结
The investigators propose a randomized non-inferiority trial that compares preoperative Fluoro Uracil (FU)-based chemoradiotherapy to radiotherapy with a simultaneous integrated boost. In patients with T3-4 rectal cancer, the latter approach is considered preferential with regard to toxicity and cost. The metabolic response of the tumor, as assessed by 18F-2-Fluoro-2-Deoxyglucose-Positron Emission tomography (18F-FDG PET) or PET-CT, will be used as a surrogate marker of cause specific outcome
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 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histopathologically confirmed rectal adenocarcinoma with an inferior border within 15 cm of the anal verge
- •the tumor has to have evidence of T3 or T4 disease on Magnetic Resonance Imaging (MRI) or endoluminal ultrasound
排除标准
- •unresectable metastatic disease
- •Eastern Cooperative Oncology Group (ECOG) performance status > 3
- •patients not deemed fit for radiotherapy, capecitabine or surgery
- •pregnant or lactating patients
- •women with child bearing potential who lack effective contraception
- •patients below 18 years old
研究组 & 干预措施
Concomitant chemoradiotherapy
Radiotherapy (23 x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily, excluding weekends
干预措施: Chemoradiotherapy (Other)
Radiotherapy with boost
Radiotherapy (23 x 2 Gy), with a simultaneous integrated boost up to 55.2 Gy on the primary tumor
干预措施: Radiotherapy with boost (Radiation)
结局指标
主要结局
reduction in metabolic tumor activity
时间窗: at baseline and at 5 to 6 weeks after neo-adjuvant therapy
次要结局
- histological downgrading (Dworak classification)(after the rectum surgery)
- acute and late toxicity, according to the National Cancer Institute (NCI) - Common Terminology Criteria for Adverse Events v3.0 (CTCAE)(at baseline, every 6 months after completion of radiotherapy and then yearly until 3 years)
- survival(every 6 months in the first year after completion of radiotherapy and then yearly until 3 years)
- progression free survival(every 6 months in the first year after completion of radiotherapy and then yearly until 3 years)
- number of R0, R1 and R2 resections(after the rectum surgery)
- local control(every 6 months in the first year after completion of radiotherapy and then yearly until 3 years)
- cost evaluation(during the treatment and follow-ups)
- quality of life(at baseline, every 6 months in the first year after completion of radiotherapy and then yearly until 3 years)
研究者
Mark De Ridder
Head of Radiotherapy Department
Universitair Ziekenhuis Brussel