CTIS2024-511609-44-00进行中（未招募）1 期
Multicentric Phase II-III study evaluating the tailored management of locally-advanced rectal carcinoma after a favorable response to Induction chemotherapy - PROICM 2021-01 GRE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 430
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Patient with tumoral regression = 60% and CRM = 1mm,, No unequivocal evidence on CT-Scan of established metastatic disease, General condition considered suitable for radical pelvic surgery and a systemic therapy with Capecitabine, Adequate hematologic, hepatic, renal and ionogram function assessed within 7 days prior to study treatment
排除标准
- •Patient with a history of pelvic radiotherapy,, Contraindication to chemotherapy and/or radiotherapy,, Complete or partial Dihydropyrimidine deshydrogenase (DPD) deficiency (uracilemia = 16 ng/mL),, Known hypersensitivity to Capecitabine drug, study drug classes, or any constituent of the products,, Pregnant or breastfeeding woman. If a patient is of childbearing age, she must have a negative pregnancy test (serum ß-hCG) documented 72 hours prior to inclusion,, Patient treated with an investigational drug within the last 30 days,
研究者
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