Clinical trial · Observational
Adjuvant Chemotherapy Regimens in Resected Biliary Tract Cancers (TOG/GI-SAFRADJU-2501)
NCT06975917CI-TRIAL-00089807TOG-SAFRADJUactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biliary Tract Cancer | Malignant Biliary Tract Neoplasm | ALIAS | 0.90 |
| Biliary Tract Cancers (BTC) | Malignant Biliary Tract Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Chemotherapy | Drug | Chemotherapy | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Patient with biliary tract cancer
- description
- Patients with biliary tract cancer, who underwent resection and received adjuvant chemotherapy
- interventionNames
- Drug: Chemotherapy
Primary outcomes (2)
- measure
- Recurrence-free survival
- timeFrame
- 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
- description
- The length of time from the start of adjuvant chemotherapy to the date of the first loco-regional or systemic recurrence or death
- measure
- Overall survival
- timeFrame
- From the date of adjuvant chemotherapy initiation until the date of death from any cause, assessed up to 180 months
- description
- The length of time from the start of adjuvant chemotherapy to the date of death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDAkkus E, Kayaalp M, Ergozoglu MA, Koc Kus I, Bayram D, Kilictas B, Ayvaz Guneyin E, Kalem A, Temizyurek H, Catli MM, Akarca MS, Mildanoglu MM, Turhan G, Kara M, Arak H, Arslan Tan F, Pacaci B, Yesilyurt B, Akdogan O, Cetin EB, Celik S, Keskin Uzundere F, Sahin E, Sadak Ocal Z, Seker Can L, Koylu B, Fidan MC, Kaplan Tuzun E, Sakalar T, Sertesen Camoz E, Yuksel HC, Balcik OY, Peker P, Yilmaz M, Ala Enli S, Kolemen E, Oyucu Orhan S, Duzkopru Y, Ersoy M, Akin Telli T, Yilmaz M, Ilhan Y, Yildirim A, Cosar R, Urun M, Onder AH, Araz M, Bayram E, Yesil Cinkir H, Alkan A, Gurbuz M, Avci N, Paksoy Turkoz F, Kara IO, Kose F, Unek IT, Bilici A, Bal O, Yalcin S, Yasar HA. Resectable Stage Early-Onset Biliary Tract Cancer: Survival and Prognostic Scoring (EOB-RS and EOB-OS) in Turkish Patients (TOG/GI-SAFRADJU-2502-EO). JCO Glob Oncol. 2026 Mar;12(3):e2500655. doi: 10.1200/GO-25-00655. Epub 2026 Mar 26. PMID 41886718