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Prospective Phase II Randomized Trial of Postoperative Adjuvant Chemotherapy in Patients With High Risk Colon Cancer

NCT00201331 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 162

Last updated 2005-12-16

No results posted yet for this study

Summary

Based on the astonishing high response rate in metastatic colorectal cancer in weekly high dose 5-FU and leucovorin, we will conduct a clinical trial to clarify the activity of this regimen in the adjuvant setting. The regimen of 5-FU and high dose leucovorin administered as the schedule of INT-0089 will be chosen as the controlled arm which was proven as effective as standard 5-FU plus levamisole regimen with short duration of treatment.21 In this study, continuous infusion of 5-FU (HDFL, Arm B) and bolus injection of 5-FU (Arm A) will be administered to the high risk colon cancer(N2 disease) patients. The role of TS level and inhibition of TS as a predictor of adjuvant chemotherapy with 5-FU based treatment will be clearly defined prospectively.

Conditions

  • Colonic Diseases
  • Adenocarcinoma

Interventions

DRUG

leucovorin+5-FU

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    collaborator OTHER

  • Changhua Christian Hospital

    collaborator OTHER

  • China Medical University Hospital

    collaborator OTHER

  • Mackay Memorial Hospital

    collaborator OTHER

  • Chi Mei Medical Hospital

    collaborator OTHER

  • Kaohsiung Veterans General Hospital.

    collaborator OTHER

  • National Cheng-Kung University Hospital

    collaborator OTHER

  • Taichung Veterans General Hospital

    collaborator OTHER

  • National Health Research Institutes, Taiwan

    lead OTHER

Principal Investigators

  • Cheng-Yi Wang, PHD · Chang Gung Memorial Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-04-30
Completion
2012-10-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00201331 on ClinicalTrials.gov