Adjuvant chemotherapy with gemcitabine and cisplatin compared to observation after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma (ACTICCA-1 trial)A randomized, multidisciplinary, multinational AIO/DGAV/DGVS phase III trial.

niversity Medical Center Hamburg-Eppendorf0 个研究点目标入组 440 人开始时间: 2016年9月15日最近更新: 2018年6月11日

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: 440

研究概览入排标准研究者记录与标识符相似试验

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

•Eligibility criteria for enrolment phase
•1. Suspicion of or histologically/cytologically confirmed adenocarcinoma of biliary tract (intrahepatic, hilar or extrahepatic cholangiocarcinoma or muscle invasive gallbladder carcinoma) scheduled for radical surgical therapy
•2. Written informed consent
•3. No prior chemotherapy for biliary tract cancer
•4. No previous malignancy within 3 years or concomitant malignancy, except: non-melanomatous skin cancer or adequately treated in situ cervical cancer
•5. No severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction in the last 3 months, significant arrhythmia)
•6. Absence of psychiatric disorder precluding understanding of information of trial related topics and giving informed consent
•7. No serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial
•8. Fertile women (< 1 year after last menstruation) and procreative men willing and able to use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)
•9. No pregnancy or lactation
•Assessments enrolment phase (for details refer to section 5.3)Preoperatively
•Obtaining signed written informed consent
•Medical and medication history, performance status (ECOG)
•Demographics
•Laboratory tests: hematology and chemistry panel, tumor markers
•Acquisition of blood for translational research
•Quality of life assessments
•Intraoperatively
•Acquisition of tissue for translational research
•Postoperatively
•Acquisition of blood for translational research (during second postoperative week)
•Evaluation of feasibility for treatment phase
•Eligibility criteria for treatment phase (before randomization)
•All enrolled patients will postoperatively be assessed for eligibility for the treatment phase. Additionally patients not previously enrolled into the trial for whatever reason (e.g. incidental finding during surgery) will be evaluated for eligibility.
•1. Histologically confirmed adenocarcinoma of biliary tract (intrahepatic, hilar or extrahepatic cholangiocarcinoma or muscle invasive gallbladder carcinoma) after radical surgical therapy with macroscopically complete resection (mixed tumor entities (HCC/CCA) are excluded)
•2. Macroscopically complete resection (R0/1) within 6 (-16) weeks before scheduled start of chemotherapy
•3. ECOG 0-1
•4. Age =18 years
•5. Adequate hematologic function: ANC = 1.5 x 10^9/L, platelets = 100 x10^9/L, hemoglobin = 9 g/dl or = 5.59 mmol/L
•6. Adequate liver function as measured by serum transaminases (AST and ALT) <= 5 x ULN and bilirubin <= 3 x ULN
•7. Adequate renal function, i.e. serum creatinine <= 1.5 x ULN, glomerular filtration rate = 60 mL/min
•8. No active uncontrolled infection, except chronic viral hepatitis under antiviral therapy
•9. No concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to randomization
•10. Negative serum pregnancy test within 7 days of starting study treatment in pre-menopausal women and women <1 year after the onset of menopause (Note: a negative test has to be reconfirmed by a urine test, should the 7-day window be exceeded)
•Criteria for initial study enrolment
•11. Written informed consent
•12. No prior chemotherapy for bilia

排除标准

•Eligibility criteria for enrolment phase
•1. Suspicion of or histologically/cytologically confirmed adenocarcinoma of biliary tract (intrahepatic, hilar or extrahepatic cholangiocarcinoma or muscle invasive gallbladder carcinoma) scheduled for radical surgical therapy
•2. Written informed consent
•3. No prior chemotherapy for biliary tract cancer
•4. No previous malignancy within 3 years or concomitant malignancy, except: non-melanomatous skin cancer or adequately treated in situ cervical cancer
•5. No severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction in the last 3 months, significant arrhythmia)
•6. Absence of psychiatric disorder precluding understanding of information of trial related topics and giving informed consent
•7. No serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial
•8. Fertile women (< 1 year after last menstruation) and procreative men willing and able to use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)
•9. No pregnancy or lactation
•Assessments enrolment phase (for details refer to section 5.3)Preoperatively
•Obtaining signed written informed consent
•Medical and medication history, performance status (ECOG)
•Demographics
•Laboratory tests: hematology and chemistry panel, tumor markers
•Acquisition of blood for translational research
•Quality of life assessments
•Intraoperatively
•Acquisition of tissue for translational research
•Postoperatively
•Acquisition of blood for translational research (during second postoperative week)
•Evaluation of feasibility for treatment phase
•Eligibility criteria for treatment phase (before randomization)
•All enrolled patients will postoperatively be assessed for eligibility for the treatment phase. Additionally patients not previously enrolled into the trial for whatever reason (e.g. incidental finding during surgery) will be evaluated for eligibility.
•1. Histologically confirmed adenocarcinoma of biliary tract (intrahepatic, hilar or extrahepatic cholangiocarcinoma or muscle invasive gallbladder carcinoma) after radical surgical therapy with macroscopically complete resection (mixed tumor entities (HCC/CCA) are excluded)
•2. Macroscopically complete resection (R0/1) within 6 (-16) weeks before scheduled start of chemotherapy
•3. ECOG 0-1
•4. Age >18 years
•5. Adequate hematologic function: ANC = 1.5 x 10^9/L, platelets = 100 x10^9/L, hemoglobin = 9 g/dl or = 5.59 mmol/L
•6. Adequate liver function as measured by serum transaminases (AST and ALT) <= 5 x ULN and bilirubin <= 3 x ULN
•7. Adequate renal function, i.e. serum creatinine <= 1.5 x ULN, glomerular filtration rate = 60 mL/min (MDRD)
•8. No active uncontrolled infection, except chronic viral hepatitis under antiviral therapy
•9. No concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to randomization
•10. Negative serum pregnancy test within 7 days of starting study treatment in pre-menopausal women and women <1 year after the onset of menopause (Note: a negative test has to be reconfirmed by a urine test, should the 7-day window be exceeded)
•Criteria for initial study enrolment
•11. Written informed consent
•12. No prior chemotherapy fo

研究者

发起方

niversity Medical Center Hamburg-Eppendorf

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