EUCTR2018-001356-35-DE进行中（未招募）1 期
ACO/ARO/AIO-18.2Preoperative FOLFOX versus postoperative risk-adapted chemotherapy in patients with locally advanced rectal cancer and low risk for local failure: A randomized phase III trial of the German Rectal Cancer Study Group
niversity of Heidelberg0 个研究点目标入组 550 人开始时间: 2020年5月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 550
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Male and female patients* with histologically confirmed diagnosis of rectal adenocarcinoma localized 0 – 16 cm from the anal verge as measured by rigid rectoscopy (i.e. lower, middle and upper third of the rectum), depending on MRI-defined inclusion criteria (see below).
- •2.Staging requirements: High-resolution, thin-sliced (i.e. 3mm) magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure.
- •3.Transrectal endoscopic ultrasound (EUS) is mandatory and used to help discriminate between T1/2 and early T3 tumors.
- •4.MRI-defined inclusion criteria:
- •i)Lower third (0-6 cm): cT1/2 with clear cN+ based on defined MRI criteria, provided CRM- and EMVI-**
- •ii)Middle third (= 6-12 cm): cT1/2 with clear cN+ provided CRM- and EMVI-**; cT3 with maximum infiltration of 10mm in the perirectal fat, provided no evidence that tumor is adjacent to (defined as within 2 mm of) the mesorectal fascia on MRI (i.e. CRM > 2 mm), N0 or N1, EMVI-**
- •iii)Upper third (= 12-16 cm): cT1/2 with clear cN+, irrespective of CRM and EMVI; any cT3-4 irrespective of nodal status, CRM and EMVI.
- •5.Spiral-CT of the abdomen and chest to exclude distant metastases.
- •6.Aged at least 18 years. No upper age limit.
- •7.WHO/ECOG Performance Status =1.
- •8.Adequate hematological, hepatic, renal and metabolic function parameters:
- •9.Leukocytes = 3.000/mm³, ANC = 2.000/mm³, platelets = 100.000/mm³, Hb > 9 g/dl
- •10.Serum creatinine = 1.5 x upper limit of normal
- •11.Bilirubin = 2.0 mg/dl, SGOT-SGPT, and AP = 3 x upper limit of normal.
- •12.QTc interval (Bazett***) = 440 ms
- •13.Informed consent of the patient.
- •* Thera are no data that indicate special gender distribution. Therefore, patients will be enrolled in the study gender-independently.
- •** defined as MRI-EMVI score 0-3; see SOP in chapter 12 of the appendix
- •*** Formula for QTc interval calculation (Bazett):
- •QTc= ((QT) ¯ (ms) )/v(RR (sec))= ((QT) ¯ (ms) )/v(60/(Frequenz (1/min)))
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 275
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 275
排除标准
- •1.Distant metastases (to be excluded by CT scan of the thorax and abdomen).
- •2.Prior antineoplastic therapy for rectal cancer.
- •3.Prior radiotherapy of the pelvic region.
- •4.Major surgery within the last 4 weeks prior to inclusion.
- •5.Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
- •6.Subject (male or female) is not willing to use highly effective**** methods of contraception during treatment and for 6 months (male or female) after the end of treatment. Male patients treated with Oxaliplatin should take legal advice concerning sperm conservation before start of therapy and should additionally use a condom during treatment period. Their female partner of childbearing potential should also use an appropriate contraceptive measure.
- •7.On-treatment participation in a clinical study in the period 30 days prior to inclusion.
- •8.Previous or current drug abuse.
- •9.Other concomitant antineoplastic therapy.
- •10.Serious concurrent diseases, including neurologic or psychiatric disorders (incl. dementia and uncontrolled seizures), active, uncontrolled infections, active, disseminated coagulation disorder.
- •11.Clinically significant cardiovascular disease (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 6 months before enrolment.
- •12.Chronic diarrhea (> grade 1 according NCI CTCAE).
- •13.Prior or concurrent malignancy = 3 years prior to enrolment in study (Exception: non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1), if the patient is continuously disease-free.
- •14.Known allergic reactions or hypersensitivity on study medication or to any of the other excipients.
- •15.Evidence of peripheral sensory neuropathy > grade 1 according to CTCAE version 5.0 (see appendix).
- •16.Severe kidney dysfunction (creatinine clearance < 30 ml/min).
- •17.Recent or concurrent treatment with brivudine.
- •18.Pernicious or other megaloblastic anaemia caused by vitamin B12 deficiency.
- •19.Known dihydropyrimidine dehydrogenase deficiency (activity score < 1,5 after genetic testing of DPYD variants).
- •20.Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule (these conditions should be discussed with the patient before registration in the trial).
- •****highly effective (i.e. failure rate of <1% per year when used consistently and correctly) methods: intravaginal and transdermal combined (estrogen and progestogen containing) hormonal contraception; injectable and implantable progestogen-only hormonal contraception; intrauterine device (IUD); intrauterine hormone-releasing system (IUS); bilateral tubal occlusion; vasectomized partner; sexual abstinence (complete abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments).
研究者
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