UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055335 |
|---|---|
| Receipt number | R000063237 |
| Scientific Title | A Prospective Observational Study on Surgical Resection after Systemic Chemotherapy for Advanced Biliary Tract Cancer |
| Date of disclosure of the study information | 2024/08/26 |
| Last modified on | 2024/08/26 10:32:06 |
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Basic information
Public title
A Prospective Observational Study on Surgical Resection after Systemic Chemotherapy for Advanced Biliary Tract Cancer
Acronym
A Prospective Observational Study on Surgical Resection after Systemic Chemotherapy for Advanced Biliary Tract Cancer
Scientific Title
A Prospective Observational Study on Surgical Resection after Systemic Chemotherapy for Advanced Biliary Tract Cancer
Scientific Title:Acronym
A Prospective Observational Study on Surgical Resection after Systemic Chemotherapy for Advanced Biliary Tract Cancer
Region
| Japan |
Condition
Condition
Advanced Biliary Tract Cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively evaluate the frequency of cases in which surgical resection becomes possible following GCS therapy in routine clinical practice for advanced biliary tract cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of surgical resection
Key secondary outcomes
Overall response rate, curative resection rate (R0), operative time, blood loss, postoperative complications (presence, type, and severity based on the Clavien-Dindo classification), overall survival, recurrence-free survival (for surgical cases only)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
No restriction on gender
Patients aged 18 years or older at the time of consent
Patients with lymph node metastasis or distant metastasis, or those strongly suspected to have such conditions
Patients who have given written informed consent to participate in this study
Key exclusion criteria
Patients deemed inappropriate by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Nagano |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
7558505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL
0836222264
hnagano@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | Yukio |
| Middle name | |
| Last name | Tokumitsu |
Organization
Yamaguchi University Graduate School of Medicine
Division name
Department of Gastroenterological, Breast and Endocrine Surgery
Zip code
7558505
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
TEL
0836222264
Homepage URL
yt790604@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Center For Clinical Research, Yamaguchi University Hospital
Address
1-1-1 Minami-Kogushi, Ube, Yamaguchi
Tel
0836-22-2428
me223@yamaguchi-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
| 2024 | Year | 08 | Month | 26 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 10 | Month | 16 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 16 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 16 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Biliary tract cancer has a high incidence among Japanese people, and systemic chemotherapy is typically indicated for advanced cases. The addition of S-1 to gemcitabine plus cisplatin therapy (GCS therapy) has shown efficacy. This study aims to investigate the feasibility of surgical resection following GCS therapy.
Management information
Registered date
| 2024 | Year | 08 | Month | 26 | Day |
Last modified on
| 2024 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063237
