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)

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 172

Inclusion Criteria

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
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
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 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
exceeded)

Exclusion Criteria

n.a.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Disease free survival (DFS)</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Disease free survival rate at 24 months<br /><br>- Recurrence free survival<br /><br>- Overall survival (OS)<br /><br>- Safety and tolerability of adjuvant chemotherapy<br /><br>- Quality of life (QoL)<br /><br>- Function of biliodigestive anastomosis<br /><br>- Rate and severity of biliary tract infections<br /><br>- Patterns of disease recurrence<br /><br>- Locoregional control</p><br>