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

NCT ID: NCT01035385

Last Updated: 2009-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

340 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2015-12-31

Brief Summary

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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

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

Conditions

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Colorectal Cancer Liver Metastasis

Keywords

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FOFLOX4 resectable liver metastasis from colorectal cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FOFLOX4,resectable liver metastasis from CRC

Group Type EXPERIMENTAL

FOFLOX4

Intervention Type 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

Interventions

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FOFLOX4

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guangdong Provincial People's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Guangdong General Hospital

Principal Investigators

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Feng Lin, Dr

Role: PRINCIPAL_INVESTIGATOR

Guangdong Provincial People's Hospital

Locations

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Guangdong General Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Feng Lin, Dr

Role: CONTACT

Phone: 86-20-83827812-60910

Facility Contacts

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Yong Li, Dr

Role: primary

Other Identifiers

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VORP019

Identifier Type: -

Identifier Source: org_study_id