EUCTR2018-000876-14-DE进行中（未招募）1 期
ACO/ARO/AIO-18.1: Short-course radiotherapy versus chemoradiotherapy, followed by consolidation chemotherapy, and selective organ preservation for MRI-defined intermediate and high-risk rectal cancer patientsA randomized phase III trial of the German Rectal Cancer Study Group - ACO/ARO/AIO-18.1
niversity Hospital Frankfurt, Goethe University0 个研究点目标入组 702 人开始时间: 2019年10月8日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 702
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
- •Male and female patients with histologically confirmed diagnosis of rectal adenocarcinoma localised 0 – 12 cm from the anocutaneous line as measured by rigid rectoscopy (i.e. lower and middle third of the rectum).
- •Staging requirements: High-resolution, thin-sliced (i.e. 3mm) magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure.
- •MRI-defined inclusion criteria: presence of at least one of the following high-risk conditions:
- •oany cT3 if the distal extent of the tumor is < 6 cm from the anocutaneous line, or
- •ocT3c/d in the middle third of the rectum (= 6-12 cm) with MRI evidence of extramural tumor spread into the mesorectal fat of more than 5 mm (>cT3b), or
- •ocT3 with clear cN+ based on strict MRI-criteria (see appendix)
- •ocT4 tumors, or
- •oTany middle/low third of rectum with clear MRI criteria for N+
- •omrCRM+ (= 1mm), or
- •oExtramural venous invasion (EMVI+).
- •Transrectal endoscopic ultrasound (EUS) is additionally used when MRI is not definitive to exclude early cT1/T2 disease in the lower third of the rectum or early cT3a/b tumors in the middle third of the rectum.
- •Spiral-CT of the abdomen and chest to exclude distant metastases.
- •Aged at least 18 years. No upper age limit.
- •WHO/ECOG Performance Status =1.
- •Adequate haematological, hepatic, renal and metabolic function parameters:
- •oLeukocytes = 3.000/mm3, ANC = 1.500/mm3, platelets = 100.000/mm3, Hb > 9 g/dl
- •oSerum creatinine = 1.5 x upper limit of normal
- •oBilirubin = 2.0 mg/dl, SGOT-SGPT, and AP = 3 x upper limit of normal.
- •Informed consent of the patient
- •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 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 102
排除标准
- •Lower border of the tumor localised more than 12 cm from the anocutaneous line as measured by rigid rectoscopy.
- •Distant metastases (to be excluded by CT scan of the thorax and abdomen).
- •Prior antineoplastic therapy for rectal cancer.
- •Prior radiotherapy of the pelvic region.
- •Major surgery within the last 4 weeks prior to inclusion.
- •Subject pregnant or breast feeding, or planning to become pregnant within 6 months after the end of treatment.
- •Subject (male or female) is not willing to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with spermicidal jelly).
- •On-treatment participation in a clinical study in the period 30 days prior to inclusion.
- •Previous or current drug abuse.
- •Other concomitant antineoplastic therapy.
- •Serious concurrent diseases, including neurologic or psychiatric disorders (incl. dementia and uncontrolled seizures), active, uncontrolled infections, active, disseminated coagulation disorder.
- •Clinically significant cardiovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) = 6 months before enrolment.
- •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.
- •Known allergic reactions on study medication.
- •Known dihydropyrimidine dehydrogenase deficiency.
- •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).
研究者
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