TNT-RECORD:Total Neoadjuvant Treatment in Rectal Cancer With On-couch Adaptive Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Incidence of acute gastro-intestinal toxicity equal or higher than grade 2
研究概览
简要总结
Diarrhea was the most frequently reported severe adverse event in the treatment regime of pre-operative sequential short-course radiotherapy followed by chemotherapy (so called total neo-adjuvant treatment).
This study therefore investigates the benefit of on-couch adaptation for locally advanced rectal cancer patients undergoing this treatment regime.
详细描述
This is a prospective single-arm study investigating the benefit of on-couch adaptation for locally advanced rectal cancer patients prescribed with pre-operative sequential short-course radiotherapy (RT) followed by Oxaliplatin-combined chemotherapy (mFOLFOX(6) or CAPOX). On-couch adaptation, where the radiation dose is tailored to the anatomy of the patient at each radiotherapy session. Firstly, the study will investigate if on-couch adaptation result in less gastro-intestinal adverse events, secondly it will reveal if this possible reduction lead to more patients being able to fulfill all cycles of prescribed chemotherapy.
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
- •Patients with loco-regional advanced rectal adenocarcinoma with clinical indications for short-course with TNT chemotherapy i.e. having at least one of the following T4a, CRM+ (≤1 mm), N1c, N2 or extramural vascular invasion (EMVI+). Patients presenting at least one of these criteria in addition to involvement of the pelvic sidewall lymph nodes (PSW) can optionally be considered.
- •ECOG status ≤ 1
- •Being willing and able to give full written consent for participation
排除标准
- •Previous rectal cancer treatment
- •Previous irradiation to the treatment area e.g. prostate cancer
- •Hip prosthesis
- •Contraindications to MRI
- •Pregnancy
- •Abnormal DPYD genotype
- •Known contraindication to 5-FU, Capecitabine or Oxaliplatin as judged by the investigators
研究组 & 干预措施
Intervention
Intervention: daily on-couch adaptive radiotherapy
干预措施: On-couch adaptive radiotherapy (Radiation)
结局指标
主要结局
Incidence of acute gastro-intestinal toxicity equal or higher than grade 2
时间窗: Up to administration of the last course of chemotherapy or week 22, whichever comes first
Incidence of acute gastro-intestinal toxicity from therapy graded according to CTCAE ver. 5.
次要结局
- Incidence of late gastro-intestinal toxicity equal or higher than grade 2(5 years)
- Number of participants that require alteration of chemotherapy due to toxicity(From treatment week 3 up to week 20)
- Number of patients with disease related treatment failure(5 years after surgery)
- Number of patients with pathological complete response (pCR)(At surgery i.e. in treatment week 23-28)
- Tumour regression grade(Baseline to response evaluation on MR in up to week 25 of the study)
- Overall survival(Follow-up until 5 years or death)