Adjuvant Chemotherapy Regimens in Resected Biliary Tract Cancers (TOG/GI-SAFRADJU-2501)

NCT ID: NCT06975917

Last Updated: 2025-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-01

Study Completion Date

2025-05-30

Brief Summary

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The goal of this observational study is to compare chemotherapy types that are given after surgery for biliary tract cancers. The main question it aims to answer is:

Are any of the chemotherapy regimens more effective in preventing recurrence, providing longer survival, or having less toxicity?

Nationwide multicenter retrospective data will be collected.

Detailed Description

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Conditions

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Biliary Tract Cancer Biliary Tract Cancers (BTC)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patient with biliary tract cancer

Patients with biliary tract cancer, who underwent resection and received adjuvant chemotherapy

Chemotherapy

Intervention Type DRUG

Any chemotherapy regimen that is used in the adjuvant setting

Interventions

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Chemotherapy

Any chemotherapy regimen that is used in the adjuvant setting

Intervention Type DRUG

Other Intervention Names

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capecitabine gemcitabine gemcitabine-cisplatin gemcitabine-capecitabine gemcitabine-oxaliplatin

Eligibility Criteria

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Inclusion Criteria

* Histologically confirmed biliary tract cancer (intrahepatic, perihilar, distal, gallbladder)
* Underwent curative-intent resection

Exclusion Criteria

* Patients with a disease without histological confirmation
* Ampullary cancers
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Turkish Oncology Group

NETWORK

Sponsor Role collaborator

Ankara University

OTHER

Sponsor Role lead

Responsible Party

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Erman Akkus

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ankara University Faculty of Medicine Department of Medical Oncology

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Related Links

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Other Identifiers

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i09-714-24

Identifier Type: -

Identifier Source: org_study_id

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