Randomized Control Trial Comparing the Impact of a Lengthening of the Interval Between the Radiochemotherapy and Surgery (7 Weeks vs. 11 Weeks) on Complete Pathological Response in Rectal Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 265
- 试验地点
- 2
- 主要终点
- Percentage of pathological complete response after pathological examination of surgical specimen defined by the absence of persistent tumor cell invasion and lymph node (ypT0N0) in group 7 weeks versus 11 weeks in the group
研究概览
简要总结
At the end of the neoadjuvant radiochemotherapy, patients are seen by their surgeon to planify the surgery. During this visit, the study will be explained them and their consent obtained. They will then be randomized between the two groups 7 weeks vs. 11 weeks. Patients were reviewed 15 days before surgery and at 1 and 3 months after surgery. Participation in this study does not change treatment, investigations and consultations usually necessary for management of rectal cancer. The objective is to improve the pathological complete response rate of the rectal cancer.
详细描述
D0: Visit of inclusion and randomization After the end of chemoradiotherapy, the patient is seen in consultation by her / him a surgeon who propose him to participate in the study. At the end of the visit if the patient agrees to participate in it, the investigator at each center will conduct the collection of written consent to the inclusion of the patient. Inclusion will be recorded in the electronic Case Report Form (e-CRF) by the investigator at each center. Randomization (7 or 11 weeks of delay) is performed by the surgeon via the software module CleanWeb randomization.
M1- 1.5 or M2.5 depending of the group randomisation A consultation with the surgeon is held within 15 days (+/- 5 days) of intervention to check the clinical response (tumor regression in rectal tumor distance from the dentate line) and planify surgery. During this visit, the surgeon noted in the e-CRF, clinical findings of the lesion and the results of further investigations.
Not specific exam is requested in the study.
M2 or M3
Surgical procedure:
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age over 18 years, no age limit higher
- •Performance status evaluated by the Eastern CooperativeOncology Group (ECOG) score: 0-1,
- •Patients with cancer of the middle or lower rectum (lesion located within 10 cm from the dentate line or 12 cm from the anal margin) proved by pathology,
- •T3-T4N0, TxN+ on ultrasound-endoscopy and MRI, without secondary localization (M0) on the thoracoabdominal (or chest radiography and abdominal ultrasound)
- •Patient who received a protocol between 45-51 Gy of radiotherapy and chemotherapy based on 5-fluorouracil for an average duration of 5 weeks for the management of rectal cancer,
- •Curative surgical treatment planned following radiochemotherapy with total mesorectal excision,
- •Free and informed consent signed by the patient,
- •Patient affiliated to a social security scheme or beneficiary of such plan(except AME)
- •Patient able, according to the investigator, to comply with the requirements of the study.
- •The cessation of chemotherapy during radiotherapy does not exclude the patient from the study.
排除标准
- •Patient with metastasis,
- •T1 or T2N0 tumor classified by echo-endoscopy and MRI,
- •rectal tumor with lower pole is more than 12 cm from the anal margin or 10 cm from the dentate line,
- •Patient did not complete the full protocol of radiotherapy,
- •History of tumors (other than basal cell carcinoma and / or carcinoma in situ of the cervix) old less than 10 years
- •A patient with impaired or incompetent investigator by not allowing him a good understanding of the requirements of the study,
- •Person under guardianship, persons under guardianship, persons deprived of their liberty by judicial or administrative body, adult subject to legal protection or unable to consent,
- •Patient did not complete the full protocole of chemotherapy,
- •Pregnant or lactating women.
结局指标
主要结局
Percentage of pathological complete response after pathological examination of surgical specimen defined by the absence of persistent tumor cell invasion and lymph node (ypT0N0) in group 7 weeks versus 11 weeks in the group
时间窗: 6 month
次要结局
- Local and distant recurrence rates, comparison between the two groups (7 versus 11 weeks)(5 years)
- Quality of mesorectum resection, comparison between the two groups (7 versus 11 weeks)(6 month)
- Rates of clinical response to radio-chemotherapy before surgery, comparison between the two groups (7 versus 11 weeks)(6 month)
- Functional results (LARS score)(24 months and 36 months)
- Rate of tumor regression, comparison between the two groups (7 versus 11 weeks)(6 month)
- Rates of operative mortality and morbidity at 90 days, comparison between the two groups (7 versus 11 weeks)(6 month)
- Rate of sphincter preservation, comparison between the two groups (7 versus 11 weeks)(6 month)
- Overall survival and disease-free survival rates, comparison between the two groups (7 versus 11 weeks)(5 years)