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IRIS Followed by mFOLFOX6 or the Reverse Sequence in Advanced Colorectal Cancer

NCT00316745 · Status: SUSPENDED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2007-11-01

No results posted yet for this study

Summary

This randomized phase III study compares safety and efficacy of two sequence arms in advanced colorectal cancer: irinotecan and S-1 (IRIS) followed by oxaliplatin containing regimen (arm A), or l-leucovorin (l-LV), 5-FU and oxaliplatin (mFOLFOX6) followed by irinotecan containing regimen (arm B).

Conditions

Interventions

DRUG

Campto, Topotesin

100 mg/m2, IV (in the vein) on day 1,15 of each cycle.

DRUG

TS-1

S-1 Day1\~14, everyday P.O.(Day 15\~28 rest)

DRUG

L-Plat

Oxaliplatin (85mg/m2) Day 1, 15

DRUG

Isovorin

l-leucovorin (200mg/m2) Day 1, 15

DRUG

5-FU

400 mg/m2, IV (in the vein) on day 1,15 of each 28 day cycle. 2400 mg/m2, CIV (in the vein) on day 1\~3 (48 hours) of each 28 day cycle.

Sponsors & Collaborators

  • Hokkaido University Hospital

    collaborator OTHER

  • Hokkaido Gastrointestinal Cancer Study Group

    lead OTHER

Principal Investigators

  • Yoshito Komatsu, MD, PhD · Hokkaido Gastrointestinal Cancer Study Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2006-04-30
Completion
2009-03-31

Countries

  • Japan

Study Locations

More Related Trials

Entities

Drugs
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 NCT00316745 on ClinicalTrials.gov