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

Colorectal Neoplasms Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01972503
• Other study ID #: Octree Study
• Status: Recruiting
• Phase: Phase 4
• First received: September 23, 2013
• Last updated: December 10, 2013
• Start date: June 2008
• Est. completion date: September 2015

Study information

• Verified date: December 2013
• Source: Fudan University
• Contact: jianmin Xu, PHD
• Phone: 008613501984869
• Email: xujmin[@]aliyun.com
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: September 2015
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Liver Neoplasms
• Neoplasm Metastasis
• Neoplasms

Intervention

Drug:
• 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.

Procedure:
• colorectal cancer resection+ adjuvant chemotherapy (mFOLFOX6)
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).

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Xu jianmin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	3 years overall survival and metastasis-free survival		3 years after operation	Yes