ACTRN12615001283561进行中（未招募）3 期
Efficacy and safety of adjuvant chemotherapy with gemcitabine and cisplatin compared to capecitabine after curative intent resection of cholangiocarcinoma and muscle invasive gallbladder carcinoma (ACTICCA-1)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 32
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •Eligibility criteria for treatment phase:
- •1. Histologically confirmed non-metastatic 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) (according to
- •appendix H)
- •2. Macroscopically complete resection (R0/1) within 6 (-16) weeks before scheduled
- •start of chemotherapy
- •3. ECOG 0-1
- •4. Age greater than or equal to 18 years
- •5. Adequate hematologic function: ANC larger than or equal to 1.5 x 10^9/L, platelets larger than or equal to 100 x10^9/L, hemoglobin larger than or equal to 9 g/dl or larger than or equal to 5.59 mmol/L
- •6. Adequate liver function as measured by serum transaminases (AST and ALT) less than or equal to 5 x ULN and bilirubin less than or equal to 3 x ULN
- •7. Adequate renal function, i.e. serum creatinine less than or equal to 1.5 x ULN, glomerular filtration rate greater than or equal to 50 ml/min (determination of GFR according to local institutional standards, e.g. MDRD, (Appendix E))
- •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 less than 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
- •Criteria for initial study enrolment:
- •11.Written informed consent
- •12.No prior chemotherapy for biliary tract cancer
- •13.No previous malignancy within 3 years or concomitant malignancy, except those
- •with a 5 year overall survival rate of more than 90%, e.g. non-melanomatous skin
- •cancer or adequately treated in situ cervical cancer
- •14.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)
- •15.Absence of psychiatric disorder precluding understanding of information of trial
- •related topics and giving informed consent
- •16.No serious underlying medical conditions (judged by the investigator), that could
- •impair the ability of the patient to participate in the trial
- •17.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)
- •18.No pregnancy or lactation
- •Additional eligibility criteria for patients to be included in the radiotherapy substudy:
- •19.R1 (microscopic positive margin)
- •20.No previous radiotherapy to abdomen
排除标准
- •* Prior chemotherapy for biliary tract cancer
- •* Previous malignancy within 3 years or concomitant malignancy, except: those with a 5 year overall survival rate of more than 90% e.g non-melanomatous skin cancer or adequately treated in-situ cervical cancer
- •* 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
- •* Presence of psychiatric disorder precluding understanding of information of trial related topics and giving informed consent
- •* Serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial
- •* Fertile women (less than 1 year after last menstruation) and procreative men unwilling and unable to use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)
- •* Pregnancy or lactation
研究者
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