Prophylactic combined chemotherapy for patients with cholangiocarcinoma after curative intent of carcinoma resection and muscle invasive gallbladder carcinoma.
- Conditions
- Cholangiocarcinoma and gallbladder carcinomaMedDRA version: 20.0 Level: LLT Classification code 10017620 Term: Gallbladder carcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0 Level: PT Classification code 10008593 Term: Cholangiocarcinoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-005078-70-DK
- Lead Sponsor
- niversity Medical Center Hamburg-Eppendorf
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 60
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 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)
11. Written informed consent
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 280
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160
1. Prior chemotherapy for biliary tract cancer
2.Previous malignancy within 3 years or concomitant malignancy, except: non-melanomatous skin cancer or adequately treated in situ cervical cancer
3. 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)
4. Psychiatric disorder precluding understanding of information of trial related topics and giving informed consent
5. Serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial
6. Fertile women (< 1 year after last menstruation) and procreative men not willing or unable to use effective means of contraception (oral contraceptives, intrauterine contraceptive device, barrier method of contraception in conjunction with spermicidal jelly or surgically sterile)
7. Pregnant or lactating women
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <br> Main Objective: The primary objective of this study is to evaluate the efficacy of gemcitabine and cisplatin compared with observation treatment in patients with BTC after complete resection in terms of DFS.<br> ;Secondary Objective: Secondary objectives are safety and tolerability of the treatment as well as OS, quality of life, function of biliodigestive anastomoses, and evaluation of the quantity and quality of information patients have gained after the informed consent as well as of the involvement of patients in the decision-making process (shared decision making).;Primary end point(s): Disease free survival (DFS);Timepoint(s) of evaluation of this end point: Every three months up to 24 month
- Secondary Outcome Measures
Name Time Method <br> Secondary end point(s): • Disease free survival rate at 24 months (DFSR@24)<br> • Overall survival (OS)<br> • Safety and tolerability of adjuvant chemotherapy<br> • Quality of life (QoL)<br> • Function of biliodigestive anastomosis (in terms of surgical revision, requirement for PTCD)<br> • Rate and severity of biliary tract infections<br> • Patterns of disease recurrence<br> • Locoregional control <br> ;Timepoint(s) of evaluation of this end point: Every three months for two years after randomization followed by 6 monthly for 3 years