Adjuvant chemotherapy with gemcitabine and cisplatin compared to standard of care after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma (ACTICCA-1 trial) - ACTICCA-1

Amsterdam UMC0 个研究点目标入组 172 人开始时间: 待定最近更新: 2024年4月23日

适应症

试验速览

阶段: 3 期
状态: 招募中
发起方
入组人数: 172

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

入排标准

年龄范围: 18 至 99（—）

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:
•nonmelanomatous
•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
•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
•Eligibility criteria for treatment phase (before randomization)
•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
•start of chemotherapy
•3. ECOG 0-1
•4. Age >18 years
•5. Adequate hematologic function: ANC >= 1.5 x 109/L, platelets >= 100
•x109/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
•premenopausal
•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

排除标准

未提供

研究者

发起方

Amsterdam UMC

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