Intraoperative Intraportal Chemotherapy Combined With Adjuvant Chemotherapy for Stage II and III Colorectal Cancer

Phase 4

• Conditions: Neoplasm Metastasis; Colorectal Neoplasms; Liver Neoplasms
• Interventions: Drug: 5-FU and oxaliplatin; Procedure: colorectal cancer resection+ adjuvant chemotherapy (mFOLFOX6)

• Registration Number: NCT01972503
• Lead Sponsor: Xu jianmin

Brief Summary

In this study, the investigators assessed whether intraoperative Intraportal infusion of 5-FU and oxaliplatin is able to prevent liver metastasis in patients receiving curative colorectal cancer resection.

Detailed Description

In this study, the investigators assessed whether intraoperative Intraportal infusion of 5-FU and oxaliplatin is able to prevent liver metastasis and improve survival in patients with Stage II or Stage III colorectal cancer without apparent liver metastasis based on a thorough preoperative evaluation.

Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms.Arm A: 5-FU 1g and oxaliplatin 100mg + curative resection (study group, n=132). Arm B: curative resection alone (control group, n=132).Follow-up: X-ray, US, CT, blood test, colonoscopy,every 3months.

The study endpoints were disease-free survival, overall survival, and liver metastasis-free survival as evaluated by intent-to-treat analysis.

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2013-09
• Study First Submitted: 2013-09-23
• Study First Submitted QC: 2013-10-24
• Study First Posted: 2013-10-30
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-10
• Last Update Posted: 2013-12-11
• Study Completion: 2015-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ARM A	5-FU and oxaliplatin	Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. In ARM A, patients accepted intraoperative intraportal infusion of 5-FU 1g and oxaliplatin 100mg + curative resection+mFOLFOX6.
ARM B	colorectal cancer resection+ adjuvant chemotherapy (mFOLFOX6)	Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. In arm B, patients accepted curative resection + mFOLFOX6 alone.
ARM A	colorectal cancer resection+ adjuvant chemotherapy (mFOLFOX6)	Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. In ARM A, patients accepted intraoperative intraportal infusion of 5-FU 1g and oxaliplatin 100mg + curative resection+mFOLFOX6.

Primary Outcome Measures

Name	Time	Method
3 years disease-free survival	3 years after operation	PFS will be defined as the period from the first day of CRC resection to the date of disease recurrence or to death.

Secondary Outcome Measures

Name	Time	Method
3 years overall survival and metastasis-free survival	3 years after operation

Trial Locations

Locations (1)

Zhongshan Hospital, Fudan University; 🇨🇳 Shanghai, Shanghai, China