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| Name | Class |
|---|---|
| Turkish Oncology Group | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient with biliary tract cancer | Patients with biliary tract cancer, who underwent resection and received adjuvant chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Chemotherapy | Drug | Any chemotherapy regimen that is used in the adjuvant setting |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From start of adjuvant chemotherapy to the date of recurrence or death in the first 2 years |
| 2-year overall survival |
| Measure | Description | Time Frame |
|---|---|---|
| Recurrence-free survival analyses in subgroups | 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
|
Inclusion Criteria:
Exclusion Criteria:
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Patients treated in any hospital (public, private, university/academic) across Türkiye
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ankara University Faculty of Medicine Department of Medical Oncology | Ankara | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41886718 | Derived | Akkus 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D001661 | Biliary Tract Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001660 | Biliary Tract Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D000069287 | Capecitabine |
| D000093542 | Gemcitabine |
| C508870 | gemcitabine-oxaliplatin regimen |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D003841 | Deoxycytidine |
| D003562 | Cytidine |
| D011741 | Pyrimidine Nucleosides |
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The length of time from the start of adjuvant chemotherapy to the date of death in the first 2 years |
| 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. | From the date of initiation of the first cycle of adjuvant chemotherapy until 1 month after the last cycle of adjuvant chemotherapy |
| 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 | 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
| From the date of adjuvant chemotherapy initiation until the date of death from any cause, assessed up to 180 months |
| D004066 |
| Digestive System Diseases |
| D011743 |
| Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D005472 | Fluorouracil |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |