NCT00868816

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for phase_4 colorectal-cancer

Timeline
Completed

Started Jan 2005

Typical duration for phase_4 colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2009

Completed
Last Updated

March 25, 2009

Status Verified

March 1, 2009

Enrollment Period

2.9 years

First QC Date

March 24, 2009

Last Update Submit

March 24, 2009

Conditions

Colorectal Cancer

Keywords

oxaliplatinecolorectal cancerchemotherapy

Outcome Measures

Primary Outcomes (1)

  • disease-free survival

    5 years after operation

Secondary Outcomes (1)

  • overall survival liver metastasis-free survival

    5 years after operation

Study Arms (2)

1

EXPERIMENTAL

12 cycles of oxaliplatine based adjuvant chemotherapy

Drug: 12 cycles of oxaliplatine based adjuvant chemotherapy

2

ACTIVE COMPARATOR

8 cycles of oxaliplatine based adjuvant chemotherapy

Drug: 8 cycles of oxaliplatine based adjuvant chemotherapy

Interventions

12 cycles of oxaliplatine based adjuvant chemotherapyDRUG

oxaliplatine 85 mg/㎡ d1, lv 200 mg/㎡ d1, 5-fu 1300 mg/㎡ ivgtt maintain for 48hr, every 3 weeks/cycle, 12 cycles

1
8 cycles of oxaliplatine based adjuvant chemotherapyDRUG

oxaliplatine 85 mg/㎡ d1, lv 200mg/㎡ d1, 5-fu 1300 mg/㎡ ivgtt maintain for 48hr, every 3 weeks/cycle, 8 cycles

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • jianmin xu, MD, PHD

    department of general surgery, zhongshan hospital, fudan university

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 24, 2009

First Posted

March 25, 2009

Study Start

January 1, 2005

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

March 25, 2009

Record last verified: 2009-03

Locations

CN(1)