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

N/AActive Not RecruitingNCT06975917

Ankara University600 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

600

Conditions

Biliary Tract Cancer Biliary Tract Cancers (BTC)

Interventions

ChemotherapyDRUG

Any chemotherapy regimen that is used in the adjuvant setting

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Ankara University Faculty of Medicine Department of Medical Oncology

Ankara, Turkey (Türkiye)

Outcomes

Primary Outcomes

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

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

Overall survival

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

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

Secondary Outcomes

2-year recurrence-free survival

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

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

2-year overall survival

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

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

The number of patients experienced toxicities

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.

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

Data from ClinicalTrials.gov

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