UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063370 |
|---|---|
| Receipt number | R000072540 |
| Scientific Title | A Phase II Clinical Trial of Adjuvant Chemoradiotherapy (S-1 Plus Radiotherapy) for the Prevention of Postoperative Recurrence in Patients with Biliary Tract Cancer |
| Date of disclosure of the study information | 2026/10/22 |
| Last modified on | 2026/10/21 21:39:23 |
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Basic information
Public title
A Phase II Clinical Trial of Adjuvant Chemoradiotherapy (S-1 Plus Radiotherapy) for the Prevention of Postoperative Recurrence in Patients with Biliary Tract Cancer
Acronym
A Phase II Clinical Trial of Adjuvant Chemoradiotherapy (S-1 Plus Radiotherapy) for the Prevention of Postoperative Recurrence in Patients with Biliary Tract Cancer
Scientific Title
A Phase II Clinical Trial of Adjuvant Chemoradiotherapy (S-1 Plus Radiotherapy) for the Prevention of Postoperative Recurrence in Patients with Biliary Tract Cancer
Scientific Title:Acronym
A Phase II Clinical Trial of Adjuvant Chemoradiotherapy (S-1 Plus Radiotherapy) for the Prevention of Postoperative Recurrence in Patients with Biliary Tract Cancer
Region
| Japan |
Condition
Condition
Biliary tract cancer
Classification by specialty
| Surgery in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility and safety of postoperative adjuvant chemoradiotherapy (S-1 plus radiotherapy) for the prevention of recurrence in patients with biliary tract cancer who have undergone curative-intent resection with biliary reconstruction and have pathologically positive resection margins, including those who achieved negative margins following additional resection.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Treatment completion rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
chemoradiation therapy
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who have undergone curative-intent resection with biliary reconstruction (hepatectomy with bile duct resection, extrahepatic bile duct resection, pancreaticoduodenectomy, or hepatopancreatoduodenectomy) and have been histopathologically diagnosed with biliary tract cancer (perihilar cholangiocarcinoma, distal cholangiocarcinoma, gallbladder cancer, ampullary carcinoma, or intrahepatic cholangiocarcinoma).
Patients with positive resection margins at the initial resection, including those who achieved negative margins following additional resection. In this study, resection margins are defined as the proximal bile duct margin, distal bile duct margin, hepatic transection margin, and radial (dissection) margin. A positive margin is defined as the presence of invasive carcinoma, carcinoma in situ, or high-grade dysplasia within 1 mm of the resection margin.
Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
Patients with adequate major organ function.
Patients who are able to tolerate oral intake.
Patients who can initiate the study treatment within 8 weeks after surgery and meet the laboratory eligibility criteria based on blood tests performed within 14 days prior to enrollment.
Patients aged 18 years or older who have sufficient decision-making capacity to provide informed consent for participation in this study.
Key exclusion criteria
Patients with pulmonary fibrosis or interstitial pneumonia.
Patients with distant metastases at the initiation of adjuvant therapy.
Patients who are unable to tolerate chemotherapy or chemoradiotherapy.
Patients with active synchronous or metachronous malignancies.
Patients with active infections.
Patients receiving flucytosine, phenytoin, or warfarin.
Patients who are pregnant or possibly pregnant.
Patients deemed unsuitable for safe participation in this study by the treating physician.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Etsuro |
| Middle name | |
| Last name | Hatano |
Organization
Kyoto University, Faculty of Medicine
Division name
Department of Surgery
Zip code
6068507
Address
54 Shogo-in Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3242
etsu@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Katsunori |
| Middle name | |
| Last name | Sakamoto |
Organization
Kyoto University, Faculty of Medicine
Division name
Department of Surgery
Zip code
6068507
Address
54 Shogo-in Kawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3242
Homepage URL
sakamo87@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kyoto University, Faculty of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
53 Shogoin-kawahara-cho, Sakyo-ku, Kyoto 606-8507, Japan
Tel
075-366-7618
ethcom@kuhp.kyoto-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 22 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2031 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 21 | Day |
Last modified on
| 2026 | Year | 10 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072540
