Biliary Tract Cancer, Biliary Tract Cancers (BTC)
Conditions
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.
Interventions
DRUGChemotherapy
Any chemotherapy regimen that is used in the adjuvant setting
Sponsors
Turkish Oncology Group
Ankara University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence-free survival | 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 |
| Overall survival | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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. |
| 2-year overall survival | 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 |
| 2-year recurrence-free survival | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) |
| 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 | 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) |
Countries
Turkey (Türkiye)
Outcome results
None listed