Role of Adjuvant Chemotherapy in Distal Cholangiocarcinoma | NCT06671431

Studies
Role of Adjuvant Chemotherapy in Distal Cholangiocarcinoma

NCT06671431

Sponsor

Seoul National University Hospital

Status

Completed

Last Update Posted

Nov 4, 2024Actual

Enrollment

578Actual

Phase

Not provided

Conditions

Distal Cholangiocarcinoma
Adjuvant Chemotherapy

Interventions

Adjuvant chemotherapy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2000Actual

Primary Completion Date

Dec 31, 2021Actual

Completion Date

Oct 1, 2024Actual

First Submitted Date

Oct 31, 2024

First Submission Date that Met QC Criteria

Oct 31, 2024

First Posted Date

Nov 4, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 31, 2024

Last Update Posted Date

Nov 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Recent studies addressing the role of adjuvant chemotherapy in cholangiocarcinoma (CCA) have been published; however, there are challenges in generalizing the findings due to different prognostic characteristics depending on tumor location and resectability. Therefore, the aim of this study was to investigate the role of AC in distal cholangiocarcinoma, a common tumor subtype of CCA.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

578Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Adjuvant chemotherapy	Drug	Adjuvant chemotherapy with or without radiotherapy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Role of Adjuvant Chemotherapy in Distal Cholangiocarcinoma		From January 2000 to December 2021

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with distal cholangiocarcinoma who underwent surgery

Exclusion Criteria:

Who underwent neoadjuvant treatment
Who underwent R2 resection
Non-adenocarcinoma patients in final pathology report
Insufficient data
Death within 90days of surgery

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patient with distal cholangiocarcinoma who underwent curative surgery

Sampling Method

Non-Probability Sample

Intervention Browse Module

MeSH Terms

ID	Term
D017024	Chemotherapy, Adjuvant

Ancestor Terms

ID	Term
D003131	Combined Modality Therapy
D013812	Therapeutics
D004358	Drug Therapy

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Browse Branches

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