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SuspendedNCT00316745Updated Nov 1, 2007

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

A Phase 3 interventional study of Campto, Topotesin and TS-1 in Metastatic Colorectal Cancer, sponsored by Hokkaido Gastrointestinal Cancer Study Group. Suspended at 1 site in Japan. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2007-11-01.

Sponsored by Hokkaido Gastrointestinal Cancer Study Group · Phase 3, Interventional, and Treatment

Why this study was suspended
Because of approval of Bevacizumab, it was difficult to perform clinical study in 1st line setting.
Phase
Phase 3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

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).

Read the detailed description

A multicenter randomized open-label controlled phase III study is conducted in patients with inoperable advanced or metastatic colorectal cancer who receive no previous chemotherapy. Usefulness of IRIS and mFOLFOX6 regimens as the 1st-line therapy for colorectal cancer is evaluated in PFS, MST, incidence and severity of adverse events

02

Conditions studied

  • Metastatic Colorectal Cancer

Keywords

  • irinotecan
  • S-1
  • Oxaliplatin
  • l-leucovorin
  • Fluorouracil
  • Metastatic colorectal cancer
  • phase III
03

In context

Colorectal Neoplasms

5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.

This study's planned enrollment of 200 is above the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Hokkaido Gastrointestinal Cancer Study Group is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Histological diagnosis of colorectal cancer. 2) Age: 18 - 75 years. 3) No prior chemotherapy 4) ECOG Performance Status 0 to 2 5) A life expectancy of at least 3 months 6) Adequate function of major organs (bone marrow, heart, lungs, liver etc.). WBC ≧3,500/mm3 and Neutrophil ≧2,000/mm3. Hb ≧10.0 g/dl. Platelet count ≧100,000/mm3. AST and ALT ≦2.5 times the upper limit of normal (excluding liver metastasis). T-Bil ≦1.5 mg/dl. Creatinine ≦1.5 mg/ dl. 7).Patients must have the ability to understand and the willingness to sign a written informed contact document.

Exclusion criteria

Exclusion Criteria:

  1. Patients receiving blood transfusion, blood derivatives or granulocyte-colony stimulating factor within 7days prior to entering the study.
  2. Patients can not have oral intake
  3. Patients receiving Flucytosine treatment
  4. Patients with severe pleural effusion or ascites.
  5. Patients who have brown brain metastasis
  6. Patients with diarrhea 4 or more times per day
  7. Patients with active gastrointestinal bleeding.
  8. Patients with intestinal obstruction
  9. Patients with active infection.
  10. Patients with serious pulmonary disease (such as interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema)
  11. Patients with serious complications (such as intestinal paralysis, intestinal obstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, or hepatic failure).
  12. Patients with significant cardiac disease.
  13. Patients with active multiple cancer.
  14. Patients with neuropathy ≥ grade 2
  15. Patients who are pregnant, are of childbearing potential, or breast-feeding.
  16. Patients with severe mental disorder.
  17. Patients with a history of serious allergic reaction.
  18. Judged to be ineligible for this protocol by the investigation.

    -

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    1

    mFOLFOX6 ( → IRIS ( Irinotecan and S-1) )

    Drug: L-Plat · Drug: Isovorin · Drug: 5-FU

  • Experimental
    2

    IRIS ( Irinotecan and S-1 ) → mFOLFOX6

    Drug: Campto, Topotesin · Drug: TS-1

Interventions

  • DrugCampto, Topotesin

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

    Also known as: Irinotecan

  • DrugTS-1

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

    Also known as: S-1

  • DrugL-Plat

    Oxaliplatin (85mg/m2) Day 1, 15

    Also known as: Oxaliplatin

  • DrugIsovorin

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

    Also known as: l-leucovorin

  • Drug5-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.

    Also known as: Fluorouracil

06

What researchers measure

Primary outcomes

  1. PFS of 1st line treatment

    Time frame: 2-years

Secondary outcomes

  1. OS

    Time frame: 4-years

  2. objective tumor response

    Time frame: 1-year

  3. PFS of 2nd line treatment

    Time frame: 1-year

  4. safety

    Time frame: 4-years

07

Study locations

1 site
  • Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine)
    Sapporo, Hokkaido 060-8638, Japan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2007, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00316745
Lead sponsor
Hokkaido Gastrointestinal Cancer Study Group
Collaborators
Hokkaido University Hospital
First posted
Apr 21, 2006
Start date
Apr 2006
Completion
Mar 2009 (estimated)
Last update
Nov 1, 2007

Study contacts

Yoshito Komatsu, MD, PhD
study chair · Hokkaido Gastrointestinal Cancer Study Group

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is suspended, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.

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