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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Fudan University
Sponsor:
Information provided by (Responsible Party):
Xu jianmin, Fudan University
ClinicalTrials.gov Identifier:
NCT01972503
First received: September 23, 2013
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention Phase
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Drug: 5-FU and oxaliplatin
Procedure: colorectal cancer resection+ adjuvant chemotherapy (mFOLFOX6)
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Fudan University:

Primary Outcome Measures:
  • 3 years disease-free survival [ Time Frame: 3 years after operation ] [ Designated as safety issue: Yes ]
    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:
  • 3 years overall survival and metastasis-free survival [ Time Frame: 3 years after operation ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: June 2008
Estimated Study Completion Date: September 2015
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ARM A
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
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).
Active Comparator: ARM B
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)
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).

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01972503

Contacts
Contact: jianmin Xu, PHD 008613501984869 xujmin@aliyun.com

Locations
China, Shanghai
Zhongshan Hospital, Fudan University Recruiting
Shanghai, Shanghai, China, 200000
Contact: jianmin Xu, PHD    008613501984869    xujmin@aliyun.com   
Sponsors and Collaborators
Xu jianmin
  More Information

No publications provided

Responsible Party: Xu jianmin, Jianmin Xu, PhD Fudan University, Fudan University
ClinicalTrials.gov Identifier: NCT01972503     History of Changes
Other Study ID Numbers: Octree Study
Study First Received: September 23, 2013
Last Updated: December 10, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Fudan University:
Colorectal Neoplasms
Liver
Neoplasm Metastasis
Tegafur
oxaliplatin

Additional relevant MeSH terms:
Colorectal Neoplasms
Neoplasms
Liver Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Liver Diseases
Neoplastic Processes
Pathologic Processes
Fluorouracil
Oxaliplatin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014