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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00316745
Recruitment Status : Suspended (Because of approval of Bevacizumab, it was difficult to perform clinical study in 1st line setting.)
First Posted : April 21, 2006
Last Update Posted : November 1, 2007
Hokkaido University Hospital
Information provided by:
Hokkaido Gastrointestinal Cancer Study Group

April 19, 2006
April 21, 2006
November 1, 2007
April 2006
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PFS of 1st line treatment [ Time Frame: 2-years ]
Complete list of historical versions of study NCT00316745 on Archive Site
  • OS [ Time Frame: 4-years ]
  • objective tumor response [ Time Frame: 1-year ]
  • PFS of 2nd line treatment [ Time Frame: 1-year ]
  • safety [ Time Frame: 4-years ]
  • OS
  • objective tumor response
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IRIS Followed by mFOLFOX6 or the Reverse Sequence in Advanced Colorectal Cancer
Irinotecan Combined With S-1( IRIS ) Followed by mFOLFOX6 Regimen Versus mFOLFOX6 Followed by IRIS Regimen in Advanced Colorectal Cancer
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).
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
Phase 3
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Metastatic Colorectal Cancer
  • Drug: Campto, Topotesin
    100 mg/m2, IV (in the vein) on day 1,15 of each cycle.
    Other Name: Irinotecan
  • Drug: TS-1
    S-1 Day1~14, everyday P.O.(Day 15~28 rest)
    Other Name: S-1
  • Drug: L-Plat
    Oxaliplatin (85mg/m2) Day 1, 15
    Other Name: Oxaliplatin
  • Drug: Isovorin
    l-leucovorin (200mg/m2) Day 1, 15
    Other Name: l-leucovorin
  • 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.
    Other Name: Fluorouracil
  • 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
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
March 2009
Not Provided

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:

  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.

Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
IFOX study
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Hokkaido Gastrointestinal Cancer Study Group
Hokkaido University Hospital
Study Chair: Yoshito Komatsu, MD, PhD Hokkaido Gastrointestinal Cancer Study Group
Hokkaido Gastrointestinal Cancer Study Group
October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP