Preoperative Chemo-radiation With IG-IMRT Dose Escalation for Locally Advanced Rectal Cancers: Phase 2 Study (RADICAL)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Complete histological response rate
研究概览
简要总结
Hypothesis : Therapeutic intensification by increasing the dose delivered to the tumor by RCMI (conformational radiotherapy by intensity modulation) in order to reduce local relapse, often associated with poor prognosis
Primary objective: evaluate the rate of tumor sterilization and the toxicities of RTCT with concomitant boost in intensity modulation in patients with rectal cancer CT3-T4 and / or cN1-2.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adenocarcinoma of the rectum cT3 or cT4 or cN+, M0 and for which CPR recommends preoperative radiochemotherapy
- •Tumor <15 cm of the anal margin in rigid or subperitoneal rectoscopy at the MRI
- •Tumor potentially resectable from the outset, or considered to be resectable after radiochemotherapy
- •Operable Patient
- •Age between 18 and 75
- •OMS performance status 0-2
- •No co-morbidity likely to prevent the delivery of treatment
- •Adequate contraception for men, and for non-menopausal women
- •Neurotrophic neutrophils 1500 / mm3, platelets 100 000 / mm3, and hemoglobin 10 g / dL
- •Bilirubin ≤ 1.5 times the upper limit of normal (LNS), ASAT and ALAT ≤ 1.5LNS, Alkaline phosphatase ≤ 1.5 LNS
- •Creatinine clearance> 50 mL / min
- •Patient must have been informed and must have signed the specific informed consent form.
- •Patient must be affiliated to a Social Health Insurance.
排除标准
- •Remote metastasis
- •Cancer not resectable
- •Contraindication to capecitabine and its excipients
- •Previous history of pelvic radiotherapy or previous chemotherapy
- •History of inflammatory bowel or rectum disease
- •History of angina pectoris monitored or myocardial infarction or heart failure
- •Active active infection or other serious underlying condition that may prevent the patient from receiving treatment
- •Other concomitant cancer, or history of cancer other than in situ cancer of the treated cervix or basal cell carcinoma or squamous cell carcinoma
- •Patient already included in another therapeutic trial with an experimental molecule
- •Pregnant woman, likely to be pregnant or nursing
- •Persons deprived of their liberty or under guardianship
- •Patient unable to comply with the required medical follow-up for geographic, social or psychological reasons
研究组 & 干预措施
Treatment
-
- Treatment : concomitant preoperative radio-chemotherapy (during 5 weeks)
Chimiotherapy: Capecitabine 1600 mg/m2/j ; 5/7 days during the 5 weeks of radiotherapy
Radiotherapy RT + SIB-IMRT (5 weeks ; 5 sessions/week ; 25 sessions): Pelvic prophylactic dose of 45 Gy (1,8 Gy/session); "boost" with a dose of 60 Gy on the tumor PTV (2,4 Gy/session) - Total dose: 60 Gy in 25 sessions during 5 weeks. 2. - TME surgery (8 weeks after the end of treatment)
干预措施: Preoperative chemo-radiation with IG-IMRT dose escalation (Radiation)
结局指标
主要结局
Complete histological response rate
时间窗: at 8 weeks after inclusion
Absence of residual cancer cells on the final analysis of the tumor and lymph node
次要结局
- Tolerance(at 1, 2, 3, 4, 5 and 13 weeks after inclusion and at 2, 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33 and 36 months after surgery)