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

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ClinicalTrials.gov Identifier: NCT01972503
Recruitment Status : Unknown
Verified December 2013 by Xu jianmin, Fudan University.
Recruitment status was:  Recruiting
First Posted : October 30, 2013
Last Update Posted : December 11, 2013
Sponsor:
Information provided by (Responsible Party):
Xu jianmin, Fudan University

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.

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

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
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.
Study Start Date : June 2008
Primary Completion Date : September 2013
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin
U.S. FDA Resources

Arm Intervention/treatment
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).



Primary Outcome Measures :
  1. 3 years disease-free survival [ Time Frame: 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 :
  1. 3 years overall survival and metastasis-free survival [ Time Frame: 3 years after operation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Xu jianmin, Jianmin Xu, PhD Fudan University, Fudan University
ClinicalTrials.gov Identifier: NCT01972503     History of Changes
Other Study ID Numbers: Octree Study
First Posted: October 30, 2013    Key Record Dates
Last Update Posted: December 11, 2013
Last Verified: December 2013

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

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Neoplastic Processes
Pathologic Processes
Liver Diseases
Oxaliplatin
Antineoplastic Agents