2024-514705-62-00招募中3 期
A phase III randomized trial evaluating chemotherapy followed by pelvic reirradiation versus chemotherapy alone as pre-operative treatment for locally recurrent rectal cancer (GRECCAR – PRODIGE – FRENCH) - GRECCAR 15
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 186
- 试验地点
- 18
- 主要终点
- Proportion of curative surgery (R0 resection)
研究概览
简要总结
To assess the efficacy of neoadjuvant chemotherapy followed by pelvic reirradiation versus neoadjuvant chemotherapy alone on the rate of curative surgery (R0) in previously irradiated patients with LRRC
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Arm B (Control): Chemotherapy alone
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Signed and dated informed consent
- •ECOG performance status < 2
- •Women not sterilized by the first treatment (ovarian transposition) and males (and their female partners) patients agree to use two methods of effective contraception (one of them being a barrier method) during the study, for at least 6 months for men and for women after the last administration of study treatment
- •Patient affiliated to a social security system or beneficiary of the same
- •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- •Age ≥ 18 years
- •First or second LRRC (histologically proven) ≤ 15 cm from the anal verge
- •Previous pelvic irradiation for the primary rectal cancer or primary recurrence (25-50.4Gy)
- •No distant metastasis
- •Resectable locally recurrent rectal cancer (according to the International consensus, absolute contraindications for resectabililty are bilateral sciatic nerve involvement, circumferential bone involvement, high sacral involvement requiring total sacrectomy; relative contraindications for resectabilty are sciatic notch involvement and encasement external iliac vessels)
- •Adequate hematologic function : Hemoglobin ≥ 9 g/dL, neutrophil count ≥ 1500/mm3, blood platelets ≥ 100 000/mm3
- •Adequate hepatic function : total bilirubin ≤ 1,5 x ULN, ASAT et ALAT ≤ 3 x ULN, alkalin phosphatases ≤ 3 x ULN
- •Adequate renal function : creatinine clearance ≥ 30 ml/min
排除标准
- •Recurrent rectal cancer after local excision
- •Complete or partial Dihydropyrimidine deshydrogenase (DPD) deficiency (uracilemia ≥ 16 ng/mL)
- •If contraindication to FOLFIRINOX, possibility to administred FOLFOX or FOLFIRI +/-EGFR (Contraindication to oxaliplatin: peripheral neuropathy > grade 1 (CTCAE grading system v5.0))
- •Concomitant treatment with millepertuis, yellow fever vaccine, live attenuated vaccine, phenytoin, warfarin or sorivudine (or chemically equivalent)
- •Pregnant or breast-feeding woman
- •Persons deprived of liberty or under guardianship or incapable of giving consent
- •Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol or follow-up schedule, as assessed by investigator
- •Concomitant cancer or medical history of cancer (other than that of rectal disease) within 5 years other than cancers treated in situ (cervical carcinoma or basocellular carcinoma or spinocellular carcinoma)
- •Contraindication for chemotherapy (refer to Summary of characteristics of the products of the study drugs available at http://base-donnees-publique.medicaments.gouv.fr) or radiotherapy or surgery
- •Symptomatic cardiac or coronary insufficiency
- •Personal or family history of long QT syndrome congenital
- •ECG at screening or baseline (predose) with QT/QTc > 450 msec (male) or QT/QTc > 470 msec (female)
- •Chronic inflammatory bowel disease and/or bowel obstruction, digestive abscess or fistula
- •Patients with hypocalcemia, hypokalemia, hypomagnesemia
- •Progressive active infection (HIV or chronic hepatitis B or C) or any other severe medical condition that may preclude the delivery of treatment
结局指标
主要结局
Proportion of curative surgery (R0 resection)
Proportion of curative surgery (R0 resection)
次要结局
- 3-year Disease Free and 3-year Overall Survival
- Surgical morbidity and mortality (Dindo classification) during first 30 days after the surgery
- Compliance to treatment: proportion of patients receiving full allocated neoadjuvant treatment
- Proportion of good tumor response: LRRC with a decreasing size of 50% after preoperative treatment (defined as good MRI radiological responders according to previous data in the literature)
- Proportion of treatment related toxicity using International Common Terminology Criteria for Adverse Events (CTCAE) grading system v5.0
- Quality of life (QLQ-C30 and QLQ-CR29) before neoadjuvant treatment, before surgery, 6 months, one year and two years after surgery
研究者
Coordinating Investigator
Scientific
Centre Hospitalier Universitaire De Bordeaux
研究点 (18)
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