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NCT Number: NCT06975917

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Biliary Tract Cancer Biliary Tract Cancers (BTC) Biliary Tract Diseases Biliary Tract Neoplasms Digestive System Diseases Digestive System Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara University Faculty of Medicine Department of Medical Oncology

Ankara, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemotherapy

Drug

Any chemotherapy regimen that is used in the adjuvant setting

Other names: capecitabine, gemcitabine, gemcitabine-cisplatin, gemcitabine-capecitabine, gemcitabine-oxaliplatin

Primary outcomes

  1. Recurrence-free survival

    Time frame: From the date of adjuvant chemotherapy initiation until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 180 months

    The length of time from the start of adjuvant chemotherapy to the date of the first loco-regional or systemic recurrence or death

  2. Overall survival

    Time frame: From the date of adjuvant chemotherapy initiation until the date of death from any cause, assessed up to 180 months

    The length of time from the start of adjuvant chemotherapy to the date of death

Secondary outcomes

  1. 2-year recurrence-free survival

    Time frame: From start of adjuvant chemotherapy to the date of recurrence or death in the first 2 years

    The length of time from the start of adjuvant chemotherapy to the date of recurrence or date in the first 2-years

  2. 2-year overall survival

    Time frame: From start of adjuvant chemotherapy to the date of death in the first 2 years

    The length of time from the start of adjuvant chemotherapy to the date of death in the first 2 years

  3. The number of patients experienced toxicities

    Time frame: From the date of initiation of the first cycle of adjuvant chemotherapy until 1 month after the last cycle of adjuvant chemotherapy

    The rates of grade 1-2 and grade 3-4 toxicities, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Other outcomes

  1. Recurrence-free survival analyses in subgroups

    Time frame: From the date of adjuvant chemotherapy initiation until the date of first documented recurrence or date of death from any cause, whichever came first, assessed up to 180 months

    Recurrence-free survival (The length of time from start of adjuvant chemotherapy to the date of the first loco-regional or systemic recurrence or death) will be analysed and compared in different subgroups.

    Subgroups

    • Age ( below 65 vs. 65 and above 65)
    • ECOG performance score (0 vs. 1)
    • Lymph node status (Positive vs negative)
    • Resection (R1 vs. R0)
    • Anatomical subtype (intrahepatic vs perihilar vs. distal vs gallbladder)

  2. Overall survival analyses in subgroups

    Time frame: From the date of adjuvant chemotherapy initiation until the date of death from any cause, assessed up to 180 months

    Overall survival (The length of time from the start of adjuvant chemotherapy to the date of death) will be analysed and compared in different subgroups.

    Subgroups

    • Age ( below 65 vs. 65 and above 65)
    • ECOG performance score (0 vs. 1)
    • Lymph node status (Positive vs negative)
    • Resection (R1 vs. R0)
    • Anatomical subtype (intrahepatic vs perihilar vs. distal vs gallbladder)

Sponsors and collaborators

Lead sponsor

Ankara University

Other

Collaborators

  • Turkish Oncology Group

Registry information

Acronym: TOG-SAFRADJU

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 16, 2025
Registry last updated
May 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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