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Oxaliplatine Based Adjuvant Chemotherapy for Stage II/III Colorectal Cancer: 8 Cycles Versus 12 Cycles

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ClinicalTrials.gov Identifier: NCT00868816
Recruitment Status : Completed
First Posted : March 25, 2009
Last Update Posted : March 25, 2009
Sponsor:
Information provided by:
Fudan University

Brief Summary:
The purpose of this study is to investigate which oxaliplatie based adjuvant method (8 cycles or 12 cycles) is better for patients receiving curative colorectal cancer resection.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Drug: 12 cycles of oxaliplatine based adjuvant chemotherapy Drug: 8 cycles of oxaliplatine based adjuvant chemotherapy Phase 4

Detailed Description:
We administered 5-FU, lv and Oxaliplatin as adjuvant chemotherapy (3 weeks per cycle) to patients with Stage II or Stage III colorectal cancer. 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)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Control Trial of Oxaliplatine Based Adjuvant Chemotherapy for Stage II/III Colorectal Cancer: 8 Cycles vs 12 Cycles
Study Start Date : January 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: 1
12 cycles of oxaliplatine based adjuvant chemotherapy
Drug: 12 cycles of oxaliplatine based adjuvant chemotherapy
oxaliplatine 85 mg/㎡ d1, lv 200 mg/㎡ d1, 5-fu 1300 mg/㎡ ivgtt maintain for 48hr, every 3 weeks/cycle, 12 cycles
Active Comparator: 2
8 cycles of oxaliplatine based adjuvant chemotherapy
Drug: 8 cycles of oxaliplatine based adjuvant chemotherapy
oxaliplatine 85 mg/㎡ d1, lv 200mg/㎡ d1, 5-fu 1300 mg/㎡ ivgtt maintain for 48hr, every 3 weeks/cycle, 8 cycles



Primary Outcome Measures :
  1. disease-free survival [ Time Frame: 5 years after operation ]

Secondary Outcome Measures :
  1. overall survival liver metastasis-free survival [ Time Frame: 5 years after operation ]


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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:

  • age < 75 years with histologically proven adenocarcinoma of the colon or rectum
  • no severe major organ dysfunction
  • 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)

Exclusion Criteria:

  • age >= 75
  • severe major organ dysfunction
  • WHO performance status of >1
  • Stage I or Stage IV

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): NCT00868816


Locations
China, Shanghai
Zhongshan Hospital, Fudan University
Shanghai, Shanghai, China, 200032
Sponsors and Collaborators
Fudan University
Investigators
Study Director: jianmin xu, MD, PHD department of general surgery, zhongshan hospital, fudan university

Responsible Party: xu jianmin, zhongshan hospital, fudan university
ClinicalTrials.gov Identifier: NCT00868816     History of Changes
Other Study ID Numbers: 2009-02
First Posted: March 25, 2009    Key Record Dates
Last Update Posted: March 25, 2009
Last Verified: March 2009

Keywords provided by Fudan University:
oxaliplatine
colorectal cancer
chemotherapy

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Oxaliplatin
Antineoplastic Agents