Radio(Chemo)Therapy Dose Escalation in Non-operative Management for Rectal Cancer: A Prospective NOM-3 Observational Study
试验速览
- 阶段
- 2 期
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Rate of patients with clinical complete response.
研究概览
简要总结
The investigators propose to conduct an observational study on consecutive patients with low-lying or mid rectal cancers smaller than 5 cm in length and less than 50% of rectal circumferential extent. The aim of this study is to test a hypothesis that escalation of either radiation or chemotherapy dose of the routine preoperative radio(chemo)therapy leads to an increase of clinical complete response rate. The planned sample size of 23 patients was calculated based on the assumption that clinical complete response rate after routine preoperative radio(chemo)therapy is 34% [1] and expected rate after radio(chemo)therapy dose escalation is 75% [2-4]. An endorectal high dose rate iridium brachytherapy boost (2 fractions of 10 Gy) will be added after the routine preoperative treatment consisted of external beam radiotherapy (5 × 5 Gy) combined with sequential 3 cycles of consolidation FOLFOX4. However, for patients with involvement of the anal canal, additional 3 cycles of consolidation FOLFOX4 (6 cycles in total) will be added instead of brachytherapy boost to avoid severe post-radiation toxicity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adenocarcinoma of the rectum classified clinically as T2, T3a-c or T4b but only with superficial infiltration of the vagina or prostate; tumour accessible by digital rectal examination; tumour ≤5 cm in length and ≤50% of rectal circumferential extent; N0-N2, but mesorectal node <7 mm and no lateral nodes enlargement); extramural vascular invasion but not larger than 7 mm in the largest dimension; M
- •Operable patient
- •Patient having read the information note and having signed the informed consent
- •Follow-up possible
排除标准
- •Inoperable patient
- •cT1, cT3d, large T4, tumour ≥5cm or ≥50 of rectal circumferential extent
- •Enlargement of lateral nodes or any node ≥8 mm in diameter
- •Patient presenting metastasis at diagnosis
- •Previous pelvic irradiation
- •Simultaneous progressive another cancer
- •Close follow-up uncertain.
研究组 & 干预措施
radiotherapy dose escalation
Additional two fractions of endorectal high dose rate iridium brachytherapy boost, 10 Gy each.
干预措施: Radiotherapy boost (Radiation)
chemotherapy dose escalation
Additional three cycles of consolidation chemotherapy consisted of 5-fluorouracil, leucovorin and oxaliplatin (FOLFOX4).
干预措施: Additional consolidation chemotherapy (Drug)
结局指标
主要结局
Rate of patients with clinical complete response.
时间窗: 15 weeks from the radiation start
Clinical complete response will be assessed by digital rectal examination, endoscopy and MRI. The analysis will take place 6 months after the start of treatment of a last enrolled patient.
次要结局
- Regrowth rate.(From 12 months to 26 months from the radiation start.)
- Anorectal function.(One year after the radiation start.)
- Acute and late toxicity assessed by Common Terminology Criteria for Adverse Events (CTCAE), version 5.(From 12 months to 26 months from the radiation start.)
研究者
Krzysztof Bujko
Clinical Professor
Maria Sklodowska-Curie National Research Institute of Oncology