EUCTR2011-002002-70-IT进行中（未招募）1 期
A RANDOMISED PHASE II TRIAL OF SECOND LINE THERAPY IN ADVANCED BILIARY TRACT CANCER: CAPECITABINE OR CAPECITABINE PLUS MITOMYCIN C (BIT-2)
FONDAZIONE CENTRO S. RAFFAELE DEL MONTE TABOR0 个研究点目标入组 57 人开始时间: 2012年1月23日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 57
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
- •1. Signed and dated IRB/IEC-approved Informed Consent. 2. Diagnosis of locally advanced or metastatic adenocarcinoma of the biliary tract (Ampulla of Vater, gallbladder, intra or extra-hepatic biliary ducts). 3. Disease progressing after first-line chemotherapy with gemcitabine and platinum analogs (only one prior systemic therapy allowed). 4. Age 18-75 years and Karnofsky Performance Status > 50%. 5. Adequate bone marrow, liver and kidney function.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 33
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 19
排除标准
- •1. Previous or concurrent malignancies at other sites with the exception of surgically cured carcinoma in-site of the cervix and basal or squamous cell carcinoma of the skin and of other neoplasm without evidence of disease at least from 5 years. 2. Known brain metastases. 3. Clinically significant cardiovascular disease
研究者
相似试验
进行中（未招募）
1 期
Randomised study for second line treatment with nal-IRI and S1 in pancreatic cancer.pancreatic cancerEUCTR2017-004675-31-NLAcademic Medical Center120
进行中（未招募）
2 期
A randomized phase II study of second line treatment with liposomal irinotecan and S1 versus liposomal irinotecan and 5-fluorouracil in patients with metastatic pancreatic cancer who failed on first line gemcitabine-based chemotherapy2023-509463-24-01Amsterdam UMC146
进行中（未招募）
1 期
Randomised study for second line treatment with nal-IRI and S1 in pancreatic cancer.pancreatic cancerEUCTR2017-004675-31-ATAcademic Medical Center120
进行中（未招募）
1 期
Phase II study of treatment with liposomal and S1 irinotecan versus liposomal and 5-fluorouracil irinotecan in patients with metastatic pancreatic cancer who did not achieve results with gemcitabine first-line chemotherapyMedDRA version: 21.0Level: LLTClassification code 10033599Term: Pancreatic adenocarcinoma metastaticSystem Organ Class: 100000004864pancreatic cancerEUCTR2017-004675-31-ITACADEMIC MEDICAL CENTRE AMSTERDAM90
招募中
2 期
A randomized Phase II study of second line treatment with liposomal irinotecan and S1 versus liposomal irinotecan and 5-fluorouracil in patients with metastatic pancreatic cancer who failed on first line gemcitabine-based chemotherapypancreatic cancer10017991NL-OMON55645Academisch Medisch Centrum25