DRKS00020770已完成3 期
Short-term radiotherapy versus chemoradiotherapy followed by consolidating chemotherapy and selective organ preservation for Patients with MRI-defined intermediate and high risk - ACO/ARO/AIO-18.1
Klinik für Strahlentherapie Universitätsklinikum Frankfurt/M0 个研究点目标入组 702 人开始时间: 2020年2月7日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 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
- 分配方式
- Randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 one（—）
- 性别
- All
入选标准
- •Male and female patients with histologically confirmed diagnosis of rectal adenocarcinoma, localized 0 - 12 cm from the anocutaneous line, measured by rigid rectoscopy (i.e. lower and
- •middle third of the rectum)
- •Staging requirements: The high-resolution, Thin-slice (i.e. 3mm) magnetic resonance imaging (MRI) of the pelvis is the mandatory local staging procedure.
- •MRI-Defined Inclusion Criteria: Presence at least one of the following high risk conditions:
- •- each cT3 if the distal extent of the tumor <6 cm from the anocutaneous line, or
- •- cT3c / d in the middle third of the rectum (= 6-12 cm) with MRI evidence of extramural spread Tumor in the mesorectal fat of more than 5 mm (> cT3b), or
- •- cT3 with clear cN + based on strict MRI criteria (see appendix)
- •cT4 tumors, or
- •- each T middle / low third of the rectum with clear MRI criteria for N +
- •- mrCRM + (= 1mm), or
- •- Extramural venous invasion (EMVI +)
- •Transrectal Endoscopic Ultrasound (EUS) is used additionally used if the MRI is not definitive, early cT1 / T2 disease in the lower third of the Rectum or early cT3a / b tumors in the middle third of the rectum to exclude Spiral CT of abdomen and chest to reveal distant metastases to exclude.
- •At least 18 years old. No age limit.
- •WHO / ECOG life status =1
- •Adequate hematological, hepatic, renal and metabolic function parameters:
- •- leukocytes = 3,000 / mm ^ 3, ANC = 1,500 / mm ^ 3, Platelets = 100,000 / mm ^ 3, Hb> 9 g / dl
- •- Serum creatinine = 1.5 x upper limit of normal value
- •- Bilirubin = 2.0 mg / dl, SGOT-SGPT and AP = 3 x Upper limit of normal value
- •Declaration of consent from the patient
排除标准
- •The lower edge of the tumor is more than 12 cm from the anocutaneous line, measured through rigid rectoscopy
- •Distant metastases (to be excluded by CT scan of Thorax and abdomen)
- •Previous antineoplastic therapy for rectal cancer
- •Prior radiotherapy to the pelvic region
- •Major surgery within the last 4 weeks before the recording
- •Pregnant or breastfeeding women or women who plan during the study or within up to 6 Getting pregnant months after completing your studies
- •Men or women who are not too consistent Contraceptive measures with a reliable method during the study and up to 6 months after the end willing or able to study
- •Simultaneous participation in a clinical study within 30 days of inclusion in the study
- •Previous or current drug abuse
- •Other concomitant antineoplastic therapy
- •Serious concurrent illnesses, including neurological or psychiatric disorders (including dementia and uncontrolled seizures) more active, uncontrolled infections, more active, more disseminated Coagulation disorder
- •Clinically significant cardiovascular disease (incl. Myocardial infarction, unstable angina pectoris, symptomatic heart failure, severe uncontrolled Cardiac arrhythmia) = 6 months prior to admission
- •Previous or concurrent malignancy = 3 years ago Inclusion in the study (exception: non-melanoma skin cancer or cervical cancer FIGO stage 0-1), if the patient is continuously disease free Known allergic reactions to Study drugs
- •Known deficiency in dihydropyrimidine dehydrogenase
- •Psychological, familial, or sociological geographic conditions that may affect the Compliance with the study protocol and the Affect aftercare plan (these conditions should be used with the Patients are discussed).
研究者
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