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

NCT06975917 | Active Not Recruiting

• 1 other identifier: i09-714-24
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Biliary Tract Cancer; Biliary Tract Cancers (BTC)

Outcome Measures

Primary Outcomes (2)

• Recurrence-free survival

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

  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

• Overall survival

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

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

Secondary Outcomes (3)

• 2-year recurrence-free survival

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

• 2-year overall survival

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

• The number of patients experienced toxicities

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

Other Outcomes (2)

• Recurrence-free survival analyses in subgroups

  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

• Overall survival analyses in subgroups

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

Study Arms (1)

Patient with biliary tract cancer

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

Drug: Chemotherapy

Interventions

Chemotherapy DRUG

Any chemotherapy regimen that is used in the adjuvant setting

Also known as: capecitabine, gemcitabine, gemcitabine-cisplatin, gemcitabine-capecitabine, gemcitabine-oxaliplatin

Patient with biliary tract cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated in any hospital (public, private, university/academic) across Türkiye

You may qualify if:

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

You may not qualify if:

• Patients with a disease without histological confirmation
• Ampullary cancers

Sponsors & Collaborators

• Ankara University: lead
• Turkish Oncology Group: collaborator

Study Sites (1)

Ankara University Faculty of Medicine Department of Medical Oncology

Ankara, Turkey (Türkiye)

Location

Related Links

• Related Info

MeSH Terms

Conditions

Biliary Tract Neoplasms

Interventions

Drug Therapy; Capecitabine; Gemcitabine; gemcitabine-oxaliplatin regimen

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 16, 2025
• Study Start: November 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)