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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Prospective,Randomized Control Trial of Intraoperative Intraportal Chemotherapy (5-FU and Oxaliplatin) Combined With Adjuvant Chemotherapy to Prevent Liver Metastasis in Patients Receiving Curative Colorectal Cancer Resection.

Conditions
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Colorectal Neoplasms, Neoplasm Metastasis, Liver Neoplasms

Intervention / Treatment
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* Drug: 5-FU and oxaliplatin
* Procedure: colorectal cancer resection+ adjuvant chemotherapy (mFOLFOX6)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Age ≥ 18 and ≤ 75 years and with histologically proven adenocarcinoma of the colon or rectum WHO performance status of 0 or 1 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 Written informed consent for participation in the trial. Exclusion criteria has prior other malignant cancer has severe major organ dysfunction has prior cancer therapy before surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARM A<br>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. | Drug: 5-FU and oxaliplatin<br>* 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.<br>Procedure: colorectal cancer resection+ adjuvant chemotherapy (mFOLFOX6)<br>* Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. All patients in both arms accept curative resection of colorectal cancer,and accept standard adjuvant chemotherapy (mFOLFOX6).<br>|
| Active Comparator: ARM B<br>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. | Procedure: colorectal cancer resection+ adjuvant chemotherapy (mFOLFOX6)<br>* Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. All patients in both arms accept curative resection of colorectal cancer,and accept standard adjuvant chemotherapy (mFOLFOX6).<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 years overall survival and metastasis-free survival |  | 3 years after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal Neoplasms, Liver, Neoplasm Metastasis, Tegafur, oxaliplatin