Adjuvant Treatment of Resectable Cholangiocellular Carcinoma (CCC) With Cisplatin Plus Gemcitabine. A Prospective Single Center Phase Ib-II Study.
1. Histologically or cytologically confirmed adenocarcinoma of biliary tract
(intrahepatic and hilar tumors). Carcinomas involving the gall bladder are allowed.
2. Macroscopically complete resection within 8 weeks before start of chemotherapy.
3. Written informed consent.
4. Health status: WHO performance status (PS) 0-1
5. Age >18 years
6. Adequate renal function (creatinine clearance ≥ 60 ml/min, calculated according to
the formula of Cockcroft-Gault)
7. Adequate hepatic function (bilirubin ≤ 3 x LUN, AP ≤ 5 x LUN, ASAT ≤ 5 x LUN)
8. Adequate hematologic function: neutrophils ≥ 1.5 x 109/l, platelets ≥ 100 x 109/l, Hb
≥ 9,5 mg/dl
9. Patient compliance and geographic proximity allowing proper staging, treatment and
10. Women who are not breastfeeding and are using effective contraception if sexually
active, who are not pregnant and agree not to become pregnant during participation in
the trial or during the 12 months thereafter. A negative pregnancy test before
inclusion into the trial is required for women < 50 years. Men who agree not to
father a child during participation in the trial or during the 12 months thereafter.
1. Pregnancy or breastfeeding women
2. Previous malignancy within 5 years or concomitant malignancy, except:
non-melanomatous skin cancer or adequately treated in situ cervical cancer
3. neutrophils < 1.5 x 109/l, platelets < 100 x 109/l, Hb < 9,5 mg/dl
4. bilirubin > 3 x LUN, ALAT > 5 x LUN, ASAT > 5 x LUN
5. Creatinine clearance < 60 ml/min, calculated according to the formula of
6. Prior chemotherapy with gemcitabine
7. Severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or
IV, unstable angina pectoris, history of myocardial infarction in the last 3 months,
8. Psychiatric disorder precluding understanding of information of trial related topics
and giving informed consent
9. Active uncontrolled infection
10. Preexisting peripheral neuropathy (> grade 1)
11. Serious underlying medical condition (judged by the investigator) which could impair
the ability of the patient to participate in the trial (e.g. uncontrolled diabetes
mellitus, active autoimmune disease)
12. Concurrent treatment with other experimental drugs or other anti-cancer therapy;
treatment in a clinical trial within 30 days prior to trial entry
13. Known hypersensitivity to the study drugs