Biliary Tract CancerTOG-SAFRADJUNCT06975917
Adjuvant Chemotherapy Regimens in Resected Biliary Tract Cancers (TOG/GI-SAFRADJU-2501)
An observational study of Biliary Tract Cancer and Biliary Tract Cancers (BTC), run by Ankara University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Cancer, Biliary Tract Cancers (BTC)
- What is being tested?
- Chemotherapy
- How many people
- 600 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 30 May 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients treated in any hospital (public, private, university/academic) across Türkiye
Who may be able to join
- Histologically confirmed biliary tract cancer (intrahepatic, perihilar, distal, gallbladder)
- Underwent curative-intent resection
Who cannot join
- Patients with a disease without histological confirmation
- Ampullary cancers
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Medicine Department of Medical Oncology
Ankara
About this study
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)
- Being tested
- Chemotherapy
- Medical subject headings
- Biliary Tract Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemotherapyDrug
Also called capecitabine, gemcitabine, gemcitabine-cisplatin, gemcitabine-capecitabine
Any chemotherapy regimen that is used in the adjuvant setting
| Study group | Role | What they receive |
|---|---|---|
| Patient with biliary tract cancer | Patients with biliary tract cancer, who underwent resection and received adjuvant chemotherapy Receives: Drug: Chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
The length of time from the start of adjuvant chemotherapy to the date of recurrence or date in the first 2-years
Measured: 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
Measured: 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.
Measured: From the date of initiation of the first cycle of adjuvant chemotherapy until 1 month after the last cycle of adjuvant chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2025
- Study start1 Nov 2024
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Biliary Tract CancerStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Collaborators
- Turkish Oncology Group
- Responsible party
- Principal investigator, Erman Akkus, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06975917
- Sponsor's protocol ID
- i09-714-24
- Acronym
- TOG-SAFRADJU
- Status last verified
- May 2025
- First submitted
- 30 Apr 2025
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41886718
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Chemotherapy Regimens in Resected Biliary Tract Cancers (TOG/GI-SAFRADJU-2501)
- ClinicalTrials.gov ID
- NCT06975917
- Acronym / sponsor ID
- TOG-SAFRADJU / i09-714-24
- Conditions
- Biliary Tract Cancer, Biliary Tract Cancers (BTC)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Collaborators
- Turkish Oncology Group
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2025 (estimated)
- First posted
- 16 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with biliary tract cancer | – | Drug: ChemotherapyPatients with biliary tract cancer, who underwent resection and received adjuvant chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients treated in any hospital (public, private, university/academic) across Türkiye
Key inclusion criteria (2 listed)
- Histologically confirmed biliary tract cancer (intrahepatic, perihilar, distal, gallbladder)
- Underwent curative-intent resection
Key exclusion criteria (2 listed)
- Patients with a disease without histological confirmation
- Ampullary cancers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemotherapyAlso: capecitabine, gemcitabine, gemcitabine-cisplatin, gemcitabine-capecitabineAny chemotherapy regimen that is used in the adjuvant setting | Drug | Patient with biliary tract cancer |
Primary outcome
Recurrence-free survival
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
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
Time frame: 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
3 secondary outcomes
2-year recurrence-free survival
Time frame: From start of adjuvant chemotherapy to the date of recurrence or death in the first 2 years
2-year overall survival
Time frame: From start of adjuvant chemotherapy to the date of death in the first 2 years
The number of patients experienced toxicities
Time frame: From the date of initiation of the first cycle of adjuvant chemotherapy until 1 month after the last cycle of adjuvant chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Derived from this study: PubMed 41886718Akkus 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.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Tract Cancer and Biliary Tract Cancers (BTC), run by Ankara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence-free survival (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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06975917, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2025.