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

A Prospective, Randomized, Control Trial of Oxaliplatine Based Adjuvant Chemotherapy for Stage II/III Colorectal Cancer: 8 Cycles vs 12 Cycles

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Drug: 12 cycles of oxaliplatine based adjuvant chemotherapy; Drug: 8 cycles of oxaliplatine based adjuvant chemotherapy

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
• Enrollment (Actual): 400
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Zhongshan Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
disease-free survival	5 years after operation

Secondary Outcome Measures

Outcome Measure	Time Frame
overall survival liver metastasis-free survival	5 years after operation

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start: January 1, 2005
• Primary Completion (ACTUAL): December 1, 2007
• Study Completion (ACTUAL): December 1, 2007

Study Registration Dates

• First Submitted: March 24, 2009
• First Submitted That Met QC Criteria: March 24, 2009
• First Posted (ESTIMATE): March 25, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): March 25, 2009
• Last Update Submitted That Met QC Criteria: March 24, 2009
• Last Verified: March 1, 2009

More Information

Terms related to this study

• Keywords: colorectal cancer; chemotherapy; oxaliplatine
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Antineoplastic Agents; Oxaliplatin
• Other Study ID Numbers: 2009-02