Preoperative Transhepatic Arterial Chemotherapy (TAC) in... | NCT00874406

Studies
Preoperative Transhepatic Arterial Chemotherapy (TAC) in the Treatment of Liver Metastasis of Resectable Colorectal Cancer

NCT00874406

Sponsor

Fudan University

Status

Unknown status

Last Update Posted

Apr 2, 2009Estimated

Enrollment

100Estimated

Phase

Phase 4

Conditions

Colorectal Cancer

Interventions

tac + folfox4
folfox4

Countries

China

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

Apr 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2008

Primary Completion Date

Dec 2009Estimated

Completion Date

Dec 2009Estimated

First Submitted Date

Apr 1, 2009

First Submission Date that Met QC Criteria

Apr 1, 2009

First Posted Date

Apr 2, 2009Estimated

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

Apr 1, 2009

Last Update Posted Date

Apr 2, 2009Estimated

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

The purpose of this study is to investigate whether preoperative TAC is able to improve progression free survival and overall survival in patients receiving liver metastasis resection of colorectal cancer.

Detailed Description

We administered TAC(oxaliplatin,FUDR and MMC) 7 days before liver metastasis resection of colorectal cancer. The study endpoints were progression free survival and overall survival as evaluated by intent-to-treat analysis.

Design Module

Study Type

Interventional

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

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	transhepatic arterial chemotherapy (TAC) were given 7 days before liver metastasis resection. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.	Drug: tac + folfox4
2	Active Comparator	Liver metastasis resection was done without TAC. Adjuvant folfox4 chemotherapy was done within 28 days after surgery.	Drug: folfox4

Interventions

Name	Type	Description	Arm Group Labels	Other Names
tac + folfox4	Drug	tac: oxaliplatin 100mg + fudr 1g + mmc 10mg 7 days later： operation within 28 days after operation: folfox4	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
progression free survival		5 years after operation

Secondary Outcomes

Measure	Description	Time Frame
overall survival		5 years after operation

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age <= 75 years
resectable liver metastasis
remnant liver volume >= 70%
without other organ metastasis or peritoneum metastasis
without contradiction of cardiac and pulmonary diseases

Exclusion Criteria:

age > 75 years
unresectable liver metastasis
remnant liver volume < 50%
with other organ metastasis or peritoneum metastasis
with contradiction of cardiac and pulmonary diseases

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
jianmin xu, MD, PHD	Contact	008613501984869		xujmin@yahoo.com.cn

Overall Officials

Name	Affiliation	Role
jianmin xu, MD, PHD	department of general surgery, zhongshan hospital, fudan university	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhongshan Hospital, Fudan University	Recruiting	Shanghai	Shanghai Municipality	200032	China

Condition Browse Module

MeSH Terms

ID	Term
D015179	Colorectal Neoplasms

Ancestor Terms

ID	Term
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014221	Triamcinolone
C410216	Folfox protocol

Ancestor Terms

ID	Term
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473	Fused-Ring Compounds

Browse Leaves

Not provided

Browse Branches

Not provided