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

NCT01035385 | Unknown Phase 3

• 1 other identifier: VORP019
• Study Type: interventional
• Target: 340
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer; Liver Metastasis

Keywords

FOFLOX4; resectable liver metastasis from colorectal cancer

Outcome Measures

Primary Outcomes (1)

• progression free survival (PFS)

  3 years

Secondary Outcomes (1)

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

  5 years

Study Arms (1)

FOFLOX4,resectable liver metastasis from CRC

EXPERIMENTAL

Drug: FOFLOX4

Interventions

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

FOFLOX4,resectable liver metastasis from CRC

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangdong Provincial People's Hospital: lead

Study Sites (1)

Guangdong General Hospital

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Feng Lin, Dr

  Guangdong Provincial People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Lin, Dr

CONTACT

86-20-83827812-60910

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 16, 2009
• First Posted: December 18, 2009
• Study Start: September 1, 2009
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2015
• Last Updated: December 18, 2009

Record last verified: 2009-09

Locations

CN (1)