Compare FOFLOX4 in Preoperative and Postoperative and Pos... | NCT01035385

Studies
Compare FOFLOX4 in Preoperative and Postoperative and Postoperative in Resectable Liver Metastasis Colorectal Cancer (MCC)

NCT01035385

Sponsor

Guangdong Provincial People's Hospital

Status

Unknown status

Last Update Posted

Dec 18, 2009Estimated

Enrollment

340Estimated

Phase

Phase 3

Conditions

Colorectal Cancer
Liver Metastasis

Interventions

FOFLOX4

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

Sep 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

Sep 2009

Primary Completion Date

Oct 2012Estimated

Completion Date

Dec 2015Estimated

First Submitted Date

Dec 16, 2009

First Submission Date that Met QC Criteria

Dec 17, 2009

First Posted Date

Dec 18, 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

Dec 17, 2009

Last Update Posted Date

Dec 18, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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

This study is a multicenter, open-label, randomized ,controlled phase III study to compare preoperative and postoperative with FOFLOX4 chemotherapy and postoperative with FOFLOX4 chemotherapy in patients with resectable liver metastasis from colorectal cancer.

Detailed Description

To investigate the three-year progression free survival (PFS) advantage of FOLFOX4 in the treatment of resectable metastatic colorectal cancer.

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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

340Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
FOFLOX4,resectable liver metastasis from CRC	Experimental		Drug: FOFLOX4

Interventions

Name	Type	Description	Arm Group Labels	Other Names
FOFLOX4	Drug	FOLFOX4:Oxaliplatin 85mg/m2 ivgtt d1 2hr calcium leucovorin:200mg/m2 ivgtt d1 d2 2hr fluorouracil:400mg/m2 iv d1 d2 fluorouracil:600mg/m2 civ d1 d2 22hr 2 weeks repeated one cycles

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
progression free survival (PFS)		3 years

Secondary Outcomes

Measure	Description	Time Frame
response rate, incidence of postoperative complications,pathological response rate,R0 resection rate, 5-year overall survival,duration of disease control		5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Resectable liver metastasis from colorectal cancer(the distance from the tumor lower edge to anal more than 12cm),no visible extrahepatic metastatic tumors. Curable by resection, as determined by a surgeon and imaging physicians. The minimum of the liver metastases needs ≥2cm. Patients can be recruited if meet the conditions about:
- Primary tumor had been removed of the metachronous liver metastasis patients and no residue from the eyes or microscope.
- Primary tumor has been removed more than 1 month of the simultaneous liver metastasis patients.
Age of≥18 and ≤80
ECOG≤2
Signed written informed consent

Exclusion Criteria:

Peripheral neuropathy(CTC>1)
Had a neurological or mental disorders
Active infection
Allergy to Platinum-based and other drugs
Other acute diseases including infection, heart-disease(CHF, stable or unstable angina)
Pregnant or nursing patients

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Feng Lin, Dr	Contact	86-20-83827812-60910

Overall Officials

Name	Affiliation	Role
Feng Lin, Dr	Guangdong Provincial People's Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Guangdong General Hospital	Recruiting	Guangzhou	Guangdong		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