DRKS00004186已完成1 期
Translational Validation Trial-B (add-on phase I/II study to the Clinical Research Unit (Klinische Forschergruppe) KFO179-2: Preoperative radiochemotherapy (RCT) combined with 5-fluorouracil (5-FU) and oxaliplatin followed by 3 cycles of FOLFOX chemotherapy (5-FU+folinic acid+oxaliplatin) and total mesorectal excision (TME-surgery) in advanced rectal cancer (clinically staged as UICC stages II, III or IV) accompanied by molecular and cell biological (translational) analysis. - TransValid-KFO179/GRCSG-B-Trial
niversitätsmedizin GöttingenGeorg-August-Universität0 个研究点目标入组 50 人开始时间: 2012年10月26日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
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
- N/a: Single Arm Study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •Males and females with histologically confirmed resectable advanced primary rectal cancer of the lower thirds of the rectum (localized within 0 to 12 cm above the anocutaneous verge as measured by rigid rectoscopy), clinically (c) classified as cT3/cT4 or cN+ carcinomas or with evidence for synchronous, but resectable distant metastases (liver metastases, pulmonary metastases)
- •- Aged 18 to 80 years, inclusive
- •- WHO/ECOG status =2
- •- Life expectancy >12weeks
- •- Adequate bone marrow function: WBC >3.0x109/L, neutrophils >1.5x109/L, thrombocytes >100x109/L, hemoglobin =10 g/dl
- •- Adequate liver function: bilirubin =2.0 mg/dl, SGOT, SGPT, AP, gamma-GT < three point five fold of upper level of normal range
- •- Creatinine clearance > 50ml/min, serum creatinine <1.5 mg/dl
- •- Written and signed informed consent of competent patient
排除标准
- •1.Prior or concurrent malignancy except non-melanoma skin cancer or cervical carcinoma FIGO stage 0-1 if the patient is successfully treated. Patients with other tumors that have been successfully treated and have not reappeared during the last 3-5 years, may be included at the principal investigator’s discretion
- •2.Simultaneous therapy with other anti-cancer drugs
- •3.Major surgery at the pelvic region 2-3 weeks prior to inclusion
- •4.Previous chemotherapy (last 2 years before diagnosis of rectal cancer)
- •5.Chronic colonic diseases
- •6.Chronic diarrhea (>grade 1 according NCI CTCAE)
- •7.Allergic reaction to platin derivates or study medication
- •8.Known Dehydropyrimidindehydrogenase (DPD) deficiency
- •9.Symptomatic neuropathia (NCI CTC >1)
- •10. Concomitant treatment with sorivudin and analogous
- •11.Disseminated infection or sepsis
- •12.Disseminated intravascular coagulopathy
- •13.Patients (man and woman) with uncontrolled, serious physical or mental diseases, e.g.: instable cardiac disease in spite of medical treatment, myocardial infarction during the last 3 months prior to start of trial participation
- •14.Men and women unwilling or unable to use highly effective methods of contraception (per institutional standard) during treatment and for 6 months (male or female) after the end of treatment.
- •15.Patients (man and woman) who are not able or willing to accept treatment and follow-up care according to trial protocol.
- •16.Participation in an AMG-clinical trial in the period 30 days prior to inclusion
- •17.Current drug abuse
- •18.neurological or psychiatric dysfunction including dementia or seizure disorder
研究者
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