2024-510580-28-00招募中3 期
NORAD01 - Non inferiority multicenter phase III randomized trial comparing preoperative chemotherapy only to chemotherapy followed by chemoradiotherapy for locally advanced resectable rectal cancer (intergroup FRENCH-GRECCAR- PRODIGE).
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 540
- 试验地点
- 37
- 主要终点
- The main endpoint of this phase III study is 3-year progression-free survival from the time to randomization.
研究概览
简要总结
To demonstrate the non-inferiority of preoperative chemotherapy only compared to chemotherapy followed by chemoradiotherapy on oncologic outcomes in locally advanced resectable low or middle rectal cancer (cT3N0 and/or cT1-T3N+)
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically proven middle or low rectal carcinoma, ≤ 12 cm from the anal verge on MRI (sagittal slide)
- •cT3N0 and/or cT1-T3N+ on pretreatment imaging work up (pelvic contrast enhanced MRI and/or endorectal ultrasound)
- •Pretreatment predictive circumferential margin > 2mm on pretreatment imaging work up (pelvic contrast enhanced MRI)
- •Patients must be 18 years old or older
- •A World Health Organization (WHO/ECOG) performance status of 0 or 1
- •Informed consent signed
- •Patients of childbearing / reproductive potential should use adequate birth control measures during the study treatment period and for at least 6 months after the last study treatment
排除标准
- •Rectal tumor > 12 cm from the anal verge on MRI (sagittal slide)
- •Contraindication to irinotecan : inflammatory bowel disease, bilirubin serum level > 3 times the upper limit of the normal rate, severe bone marrow insufficiency, WHO/ECOG performence status > 2
- •Concomitant treatment with millepertuis
- •Contraindication to oxaliplatin : bone marrow insufficiency before treatment initiation (neutrophil count <2x109/L and/or platelet count <100x109/L), peripheral neuropathy with permanent invalidity before treatment initiation
- •Contraindications to folinic acid : Biermer anemia and other anemia related to B12 vitamin insufficiency
- •Contraindications to capecitabine : severe renal insufficiency (Creatinin clearance <30 ml/min), complete and permanent insufficiency in dihydropyrimidine dehydrogenase
- •Live attenuated vaccine should not be used during and 6 months after preoperative treatment
- •Previous colorectal cancer
- •Other concomitant or previous malignancy, except: i/ adequately treated in-situ carcinoma of the uterine cervix, ii/ basal or squamous cell carcinoma of the skin, iii/ cancer in complete remission for >5 years
- •Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •Protected adults
- •cT4 tumor on pretreatment imaging work up (pelvic contrast enhanced MRI and/or endorectal ultrasound) or involvement of external sphincter
- •Pregnancy or breastfeeding
- •Patient with no national health or universal plan affiliation coverage
- •Circumferential margin ≤ 2 mm on pretreatment imaging work up (pelvic contrast enhanced MRI)
- •Metastatic disease
- •Prior pelvic irradiation or any contraindication to pelvic irradiation
- •Contraindication to oxaliplatin or irinotecan or 5FU based chemotherapy
- •Concomitant treatment with warfarin is contraindicated and warafarin must be replaced whenever possible to allow for inclusion
- •Recent or concomitant treatment with brivudine is contraindicated
- •Contraindications to 5-FU: complete and permanent insufficiency in dihydropyrimidine dehydrogenase, bone marrow insufficiency, chronic and severe infection
结局指标
主要结局
The main endpoint of this phase III study is 3-year progression-free survival from the time to randomization.
The main endpoint of this phase III study is 3-year progression-free survival from the time to randomization.
次要结局
未报告次要终点
研究者
Project Manager
Scientific
Assistance Publique Hopitaux De Paris
研究点 (37)
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