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

This study has been completed.
Sponsor:
Information provided by:
Fudan University
ClinicalTrials.gov Identifier:
NCT00868816
First received: March 24, 2009
Last updated: NA
Last verified: March 2009
History: No changes posted
  Purpose

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 Intervention Phase
Colorectal Cancer
 Drug: 12 cycles of oxaliplatine based adjuvant chemotherapy
Drug: 8 cycles of oxaliplatine based adjuvant chemotherapy
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

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

Further study details as provided by Fudan University:

Primary Outcome Measures:
  • disease-free survival [ Time Frame: 5 years after operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall survival liver metastasis-free survival [ Time Frame: 5 years after operation ] [ Designated as safety issue: No ]

Enrollment: 400
Study Start Date: January 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: xu jianmin, zhongshan hospital, fudan university
ClinicalTrials.gov Identifier: NCT00868816     History of Changes
Other Study ID Numbers: 2009-02
Study First Received: March 24, 2009
Last Updated: March 24, 2009
Health Authority: China: Ministry of Health

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
Adjuvants, Immunologic
Oxaliplatin
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013