Case Series Study of Biliary Tract Cancer Patients in Japan | NCT01294085

Studies
Case Series Study of Biliary Tract Cancer Patients in Japan

NCT01294085

Sponsor

Kansai Hepatobiliary Oncology Group

Status

Completed

Last Update Posted

Nov 28, 2011Estimated

Enrollment

300Actual

Phase

Not provided

Conditions

Biliary Tract Cancer

Interventions

Not provided

Countries

Japan

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
UMIN000004530	Registry Identifier	UMIN

Status Module

Record Verification Date

Nov 2011

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

Nov 2010

Primary Completion Date

Feb 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Jan 3, 2011

First Submission Date that Met QC Criteria

Feb 9, 2011

First Posted Date

Feb 11, 2011Estimated

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

Nov 24, 2011

Last Update Posted Date

Nov 28, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To assess the difference of prognosis between unresectable and recurrent biliary tract cancer and evaluate prognostic factors.

Detailed Description

Most patients of biliary tract cancer have advanced disease at diagnosis and often relapse despite surgery. Combination therapy of gemcitabine and cisplatin could be a standard therapy for this kind of cancer with the evidence of phase III study compared with gemcitabine alone. However the prognosis and the tolerability of chemotherapy in the patients with recurrent biliary tract cancer after radical resection might differ from those of unresectable biliary tract cancer, because the dose intensity of chemotherapy can be influenced by adjuvant chemotherapy and/or hepatic resection.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

300Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
One year survival rate		1 year

Secondary Outcomes

Measure	Description	Time Frame
Overall survival time		3 years
Number of participants with adverse events		3 years
Progression free survival

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Unresectable or recurrent biliary tract cancer

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

300

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Tatsuya Ioka, MD	Osaka Medical Center for Cancer and CVD	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Osaka Medical Center for Cancer and Cardiovascular Diseases		Osaka			Japan

Type	Date	Date Unknown
Release	Apr 1, 2015
Reset	Apr 14, 2015
Release	May 7, 2015
Unrelease		Yes
Release	May 11, 2015
Unrelease		Yes
Release	May 12, 2015
Unrelease		Yes
Release	May 14, 2015
Reset	May 29, 2015

Submission Tracking

Estimated Results First Submitted Date

Apr 1, 2015

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Apr 1, 2015			Apr 14, 2015
May 7, 2015

Condition Browse Module

MeSH Terms

ID	Term
D001661	Biliary Tract Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D001660	Biliary Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided