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

NCT ID: NCT01035385

Condition: Colorectal Cancer
Liver Metastasis

Conditions: Official terms:
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms

Conditions: Keywords:
FOFLOX4
resectable liver metastasis from colorectal cancer

Study type: Interventional

Study phase: Phase 3

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: FOFLOX4
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
Arm group label: FOFLOX4,resectable liver metastasis from CRC

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Guangdong General Hospital

Address:
City: Guangzhou
Country: China

Status: Recruiting

Contact:
Last name: Yong Li, Dr
Email: yongyongsamrt@yahoo.cn

Investigator:
Last name: Yong Li
Email: Sub-Investigator

Start date: September 2009

Completion date: December 2015

Lead sponsor:
Agency: Guangdong Provincial People's Hospital
Agency class: Other

Source: Guangdong Provincial People's Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01035385

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