DRKS00003659已完成未知
Translational validation study to examine KFO179-1 biomarker scores for the prediction and prognosis of advanced primary resectable rectal cancer stages UICC II-IV, with a 5-FU-based standard radiochemotherapy followed by total mesorectal excision. - TransValid-KFO179/GRCSG-A
niversitätsmedizin GöttingenGeorg-August-Universität0 个研究点目标入组 200 人开始时间: 2012年10月24日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 200
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 85 Years（—）
- 性别
- All
入选标准
- •Aged 18 to 85 years, inclusive
- •- Histologically confirmed advanced primary rectal cancer localized up to 12 cm above the anocutaneous line (determined with a rigid rectoscope), classified as T3/T4 or N+ carcinomas or with evidence for synchronous, but resectable distant metastases (liver or lung metastases)
- •- No specific tumor treatment except colostomy due to tumor stenosis with ileus
- •- WHO/ECOG status =2
- •- Adequate bone marrow function (WBC >3.0x10^9/L, neutrophils >1.5x10^9/L, thrombocytes >100x10^9/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
- •- serum creatinine < 1.5 mg/dl
- •- Written and signed informed consent indicating the understanding of the investigational nature and the study protocol.
排除标准
- •- Pregnant or lactating women
- •- 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
- •- Prolonged drug, medication or alcohol abuse
- •- Previous chemotherapy (up to 2 years before diagnosis of rectal cancer)
- •- Previous radiotherapy to the pelvic area
- •- Simultaneous therapy with other anti-cancer drugs
- •- Participation in a clinical trial in the period 30 days prior to inclusion
- •- Patients (man and woman) who are not able or willing to accept treatment and follow-up care according to trial protocol
- •- 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
- •+ neurological or psychiatric dysfunction including dementia or seizure disorder
- •+ Disseminated infection or sepsis
- •+ Disseminated intravascular coagulopathy
- •+ Symptomatic neuropathia (NCI CTC =2)
- •- Patients with secondary malignancies except basal cell carcinoma of the skin or carcinoma in situ of the cervix, which have been successfully treated. (The inclusion of patients with other tumors that were successfully treated and no recurrence within the last 3-5 years should be discussed before registration in the trial)
- •- Chronic diarrhea (>grade 1 according NCI CTCAE)
- •- Allergic reaction to platin-derivates or study medication
- •- Simultaneous treatment with sorivudin and analogous
- •- Known Dihydropyrimidine dehydrogenase deficiency
研究者
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