search
Back to results

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

Primary Purpose

Colorectal Cancer, Liver Metastasis

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
FOFLOX4
Sponsored by
Guangdong Provincial People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colorectal Cancer focused on measuring FOFLOX4, resectable liver metastasis from colorectal cancer

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 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.
  2. Age of≥18 and ≤80
  3. ECOG≤2
  4. Signed written informed consent

Exclusion Criteria:

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

Sites / Locations

  • Guangdong General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

FOFLOX4,resectable liver metastasis from CRC

Arm Description

Outcomes

Primary Outcome Measures

progression free survival (PFS)

Secondary Outcome Measures

response rate, incidence of postoperative complications,pathological response rate,R0 resection rate, 5-year overall survival,duration of disease control

Full Information

First Posted
December 16, 2009
Last Updated
December 17, 2009
Sponsor
Guangdong Provincial People's Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01035385
Brief Title
Compare FOFLOX4 in Preoperative and Postoperative and Postoperative in Resectable Liver Metastasis Colorectal Cancer (MCC)
Official Title
Phase III Study to Compared Preoperative and Postoperative With FOFLOX4 Chemotherapy and Postoperative With FOFLOX4 Chemotherapy in Patients With Resectable Liver Metastasis From Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Guangdong Provincial People's Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Liver Metastasis
Keywords
FOFLOX4, resectable liver metastasis from colorectal cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
340 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
FOFLOX4,resectable liver metastasis from CRC
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
FOFLOX4
Intervention Description
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
Primary Outcome Measure Information:
Title
progression free survival (PFS)
Time Frame
3 years
Secondary Outcome Measure Information:
Title
response rate, incidence of postoperative complications,pathological response rate,R0 resection rate, 5-year overall survival,duration of disease control
Time Frame
5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feng Lin, Dr
Phone
86-20-83827812-60910
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Feng Lin, Dr
Organizational Affiliation
Guangdong Provincial People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guangdong General Hospital
City
Guangzhou
State/Province
Guangdong
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Li, Dr
Email
yongyongsamrt@yahoo.cn
First Name & Middle Initial & Last Name & Degree
Yong Li

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs