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A Phase III Trial Comparing UFT+PSK to UFT+LV in Stage IIB, III Colorectal Cancer

NCT00385970 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 380

Last updated 2012-10-26

No results posted yet for this study

Summary

To compare the efficacy of tegafur/uracil (UFT) plus folinate calcium (leucovorin: LV) administered orally and UFT plus Krestin (PSK) administered orally enrolling patients with pTNM stage IIB or III colorectal cancer as subjects in a multicenter collaborative randomized open-label comparative controlled study and consequently to determine the usefulness of the above regimens as adjuvant therapy after surgery.

Conditions

Interventions

DRUG

Tegafur-uracil (UFT)

From within 9 weeks after surgery, 300 mg/m2, PO from day 1 to day 28 of each 35 day cycle. Number of Cycles: 5

DRUG

Calcium folinate (LV)

From within 9 weeks after surgery, 75 mg, PO from day 1 to day 28 of each 35 day cycle. Number of Cycles: 5

DRUG

Krestin (PSK)

From within 9 weeks after surgery to 12 months after surgery, 3 g/day, PO every day

Sponsors & Collaborators

  • Multicenter Clinical Study Group of Osaka, Colorectal Cancer Treatment Group

    lead OTHER

Principal Investigators

  • Morito Monden, MD, PhD · Multicenter Clinical Study Group of Osaka

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • Japan

Study Locations

More Related Trials

Entities

Diseases

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 NCT00385970 on ClinicalTrials.gov