CompletedPhase 3

Neoadjuvant Chemotherapy With Gemcitabine Plus Cisplatin Followed by Radical Liver Resection Versus Immediate Radical Liver Resection Alone With or Without Adjuvant Chemotherapy in Incidentally Detected Gallbladder Carcinoma After Simple Cholecystectomy or in Front of Radical Resection of BTC

Germany68 participantsStarted 2019-07-01

Plain-language summary

Neoadjuvant chemotherapy with gemcitabine plus cisplatin followed by radical liver resection versus immediate radical liver resection alone with or without adjuvant chemotherapy in incidentally detected gallbladder carcinoma after simple cholecystectomy or in front of radical resection of BTC (ICC/ECC)

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Incidental gallbladder carcinoma (IGBC), gallbladder carcinoma (GBC) () or Biliary tract cancer (BTC) (intrahepatic, hilar or distal Cholangiocarcinoma (CCA)) scheduled for complete resection (mixed tumor entities with hepatocellular carcinoma are excluded).
✓. No prior partial or complete tumor resection for BTC (intrahepatic, hilar or distal CCA), and for IGBC/GBC prior Cholecystectomy is allowed.

Exclusion criteria

✕. ECOG performance status of 0, 1, or 2.
✕. Estimated life expectancy \> 3 months.
✕. Female and male patients1 ≥18 years.
✕. Patient able and willing to provide written informed consent and to comply with the study protocol and with the planned surgical procedures
✕. No previous or preceding cytotoxic or targeted therapy for BTC or IGBC/GBC.
✕. No previous malignancy within two years or concomitant malignancy, except for curatively treated basal cell carcinoma of the skin, in situ carcinoma of the cervix, and prostate cancer
✕0. No severe or uncontrolled cardiovascular disease (congestive heart failure NYHA III or IV, unstable angina pectoris, history of myocardial infarction in the last three months, significant arrhythmia).
✕1. Absence of psychiatric disorder precluding understanding of information of trial related topics and giving informed consent.

What they're measuring

Primary efficacy endpoint is overall survival (OS)

Timeframe: up to 6 years follow-up

Trial details

NCT IDNCT03673072

SponsorKrankenhaus Nordwest

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-10-10

View on ClinicalTrials.gov More Incidental Gallbladder Carcinoma trials