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Clinical Trials in Germany / NCT02170090
Active, not recruiting Phase 3

Adjuvant Chemotherapy With Gemcitabine and Cisplatin Compared to Standard of Care After Curative Intent Resection of Biliary Tract Cancer

NCT02170090 · tracked via the Priya Life Science Germany tracker
Phase
Phase 3
Started
2014-04
Last updated
2025-03-30

Condition(s) studied

CholangiocarcinomaGall Bladder Carcinoma

Investigational drug(s) / intervention(s)

Gemcitabine →Cisplatin →Capecitabine →

Gemcitabine: Gemcitabine 1000mg/m2

Cisplatin: Cisplatin 25mg/m2

Capecitabine: Capecitabine 1250mg/m2

Study summary

This is a multicenter, prospective, randomized, controlled phase III trial designed to assess the clinical performance of gemcitabine with cisplatin and observation vs. standard of care (observation alone in stage 1 and capecitabine and observation in stage 2) in patients after curative intent resection of BTC.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
All enrolled patients will postoperatively be assessed for eligibility for the treatment phase. Additionally patients not previously enrolled into the trial for whatever reason (e.g. incidental finding during surgery) will be evaluated for eligibility. * 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) * Macroscopically complete resection (R0/1) within 6 (-16) weeks before scheduled start of chemotherapy * ECOG 0-1 * Age ≥18 years * Adequate hematologic function * Adequate liver function * Adequate renal function * No active uncontrolled infection, except chronic viral hepatitis under antiviral therapy * No concurrent treatment with other experimental drugs or other anti-cancer therapy, treatment in a clinical trial within 30 days prior to randomization * 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) Criteria for initial study enrolment * Written informed consent * No prior chemotherapy for cholangiocarcinoma * No previous malignancy within 3 years or concomitant malignancy, except: non-melanomatous skin cancer or adequately treated in situ cervical cancer * 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) * Absence of psychiatric disorder precluding understanding of information of trial related topics and giving informed consent * No serious underlying medical conditions (judged by the investigator), that could impair the ability of the patient to participate in the trial * 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) * No pregnancy or lactation

Primary outcome measure(s)

Trial sites (67)

FacilityCityRegionStatus
Bankstown Hospital Bankstown New South Wales
Nepean Hospital Cancer Care Kingswood New South Wales
St. George Hospital Kogarah New South Wales
Prince of Wales Hospital Randwick New South Wales
Calvary Mater Newcastle Waratah New South Wales
Townsville Hospital Douglas Queensland
Royal Brisbane and Women's Hospital Herston Queensland
Princess Alexandra Hospital Woolloongabba Queensland
Flinders Medical Centre Bedford Park South Australia
Fiona Stanley Hospital Perth Murdoch Western Australia
Sir Charles Gairdner Hospital Nedlands Western Australia
St. John of God Subiaco Western Australia
Kaiser-Franz-Josef Hospital Vienna Austria
Vejle Hospital Vejle Denmark
University Medical Center Hamburg-Eppendorf Hamburg Free and Hanseatic City of Hamburg
University Medical Center Aachen Aachen Germany
Charite Berlin Berlin Germany
University Medical Center Carl Gustav Carus Dresden Germany
University Medical Center Essen Essen Germany
Klinikum Esslingen Esslingen am Neckar Germany
University of Frankfurt Frankfurt Germany
University Medical Center Freiburg Freiburg im Breisgau Germany
University of Hannover Hanover Germany
University of Heidelberg Heidelberg Germany
University of Saarland Homburg Germany
University Medical Center Jena Jena Germany
Johannes Gutenberg University of Mainz Mainz Germany
University of Mannheim Mannheim Germany
University of Munich Grosshadern Munich Germany
University of Regensburg Regensburg Germany
University Medical Center Tuebingen Tübingen Germany
University of Ulm Ulm Germany
University Medical Center Würzburg Germany
Istituto Oncologico Veneto IRCCS Padova Padova
Azienda Ospedaliero Medica 2 Universitaria Pisa Pisa
Fondazione Policlinico Gemelli, Roma Rome Rome
Istituto Nazionale dei Tumori Milan Italy
Ospedale San Raffaele Milan Italy
Academic Medical Center Amsterdam Netherlands
University Medical Center Maastricht Netherlands

+ 27 more sites — see the full list on the official registry below.

More Universitätsklinikum Hamburg-Eppendorf trials in Germany

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02170090 on ClinicalTrials.gov ↗ ← All trials in Germany