Intraoperative Intraportal Chemotherapy Combined With Adjuvant Chemotherapy for Stage II and III Colorectal Cancer
Conditions
Colorectal Neoplasms - Neoplasm Metastasis - Liver Neoplasms
Conditions: official terms
Colorectal Neoplasms - Liver Neoplasms - Neoplasm Metastasis - Neoplasms
Conditions: Keywords
Colorectal Neoplasms, Liver, Neoplasm Metastasis, Tegafur, oxaliplatin
Study Type
Interventional
Study Phase
Phase 4
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
Intervention
Name: 5-FU and oxaliplatin Type: Drug
Name: colorectal cancer resection+ adjuvant chemotherapy (mFOLFOX6) Type: Procedure
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion criteria

1. Age ≥ 18 and ≤ 75 years and with histologically proven adenocarcinoma of the colon or rectum

2. WHO performance status of 0 or 1

3. Stage II (T3-4, N0, M0) or Stage III (T0-4, N1-2, M0) disease (according to the 1997 revision of the International Union Against Cancer TNM staging system) as determined by a preoperative evaluation that included colonoscopy and an abdominal computed tomography (CT) scan

4. Written informed consent for participation in the trial.

Exclusion criteria

1. has prior other malignant cancer

2. has severe major organ dysfunction

3. has prior cancer therapy before surgery
Location
Zhongshan Hospital, Fudan University
Shanghai, Shanghai, China
Status: Recruiting
Contact: jianmin Xu, PHD - 008613501984869 - xujmin@aliyun.com
Start Date
June 2008
Completion Date
September 2015
Sponsors
Xu jianmin
Source
Fudan University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page