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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

NCT03673072 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2024-11-12

No results posted yet for this study

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)

Conditions

  • Incidental Gallbladder Carcinoma
  • Biliary Tract Cancer

Interventions

DRUG

Gemcitabine

Gemcitabine (1000 mg/m2) in 250-500 ml 0.9% saline every three weeks on days 1 and 8 intravenously

DRUG

Cisplatin

Cisplatin (25 mg/m2) every three weeks on days 1 and 8 intravenously, in 1000 ml 0.9% saline with KCl 20 mmol and MgSO4 8 mmol during the one hour cisplatin infusion followed by 500 ml 0.9% saline over 30 minutes prior to gemcitabine; with adequate pre- and posthydration

PROCEDURE

Oncologically radical margin-free (R0) resection

Oncologically radical margin-free (R0) resection

DRUG

Adjuvant chemotherapy

Can be selected by Investigator's Choice

Sponsors & Collaborators

  • German Research Foundation

    collaborator OTHER

  • Krankenhaus Nordwest

    lead OTHER

Principal Investigators

  • Thorsten O Goetze, PD Dr. · Krankenhaus Nordwest

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-01
Primary Completion
2024-10-10
Completion
2024-10-10

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03673072 on ClinicalTrials.gov