EUCTR2011-004228-37-DE进行中（未招募）1 期
Translational Validation Trial-B (add-on phase I/II study to the ClinicalResearch Unit (Klinische Forschergruppe) KFO179-2 - TransValid-KFO179/GRCSG-B
niversitätsmedizin Goettingen0 个研究点目标入组 50 人开始时间: 2012年4月19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
- 50
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
- •-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, cM+)
- •Staging requirements:
- •--Transrectal endoscopic ultrasound is the mandatory local staging
- •--Additional high-resolution, thin-sliced (i.e. 3 mm) magnetic resonance
- •imaging (MRI) of the pelvis to classify infiltration depth and/or cN+
- •status or extramural venous cancer invasion (based on MRI-criteria)
- •--abdominal sonography and chest x-ray /or contrast-enhanced
- •computed tomography scan of the thorax and abdomen (and pelvis, if
- •EUS and/or MRI are not available) to complete UICC staging
- •classification
- •-Aged 18 to 80 years, inclusive
- •-WHO/ECOG status =2
- •-Life expectancy =weeks
- •-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 < threefold of upper level of normal range
- •-Creatinine clearance > 50ml/min, serum creatinine =1.5 mg/dl
- •-Written and signed informed consent of competent 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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 50
排除标准
- •- Prior or concurrent malignancy (=3 years prior to enrolment in study)
- •except non-melanoma skin cancer or cervical carcinoma FIGO stage 0 1
- •if the patient is continuously disease-free patients with other tumors
- •that have been successfully treated and have not reappeared during the
- •last 3 years, may be included at the principal investigator's discretion
- •- Simultaneous therapy with other anti-cancer drugs
- •- Major surgery at the pelvic region 2-3 weeks prior to inclusion
- •- Previous multimodal treatment of rectal cancer
- •- Chronic colonic diseases
- •- Chronic diarrhea (>grade 1 according NCI CTCAE)
- •- Allergic reaction to platin-derivates or study medication
- •- Symptomatic neuropathia (NCI CTC =2)
- •- Simultaneous treatment with sorivudin and analogous
- •- Known Dihydropyrimidine dehydrogenase deficiency
- •- Cardiac infarction/failure within 3 months before start of multimodal
- •- Disseminated infection or sepsis
- •- Activated disseminated intravasal coagulopathia
- •- Subject pregnant or breast feeding, or planning to become pregnant
- •within 6 months after the end of treatment
- •- 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 (adequate: oral contraceptives, intrauterine device or barrier method in conjunction with
- •spermicidal jelly)
- •- Participation in an AMG-clinical trial in the period 30 days prior to
- •- Current drug abuse
- •- 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)
- •- Insufficient compliance of the patient
研究者
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