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Irinotecan Combined With S-1( IRIS ) Followed by mFOLFOX6 Regimen Versus mFOLFOX6 Followed by IRIS Regimen in Advanced Colorectal Cancer

Phase 3
18 Years
75 Years
Not Enrolling
Metastatic Colorectal Cancer

Thank you

Trial Information

Irinotecan Combined With S-1( IRIS ) Followed by mFOLFOX6 Regimen Versus mFOLFOX6 Followed by IRIS Regimen in Advanced Colorectal Cancer

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

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.


Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

PFS of 1st line treatment

Outcome Time Frame:


Principal Investigator

Yoshito Komatsu, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Hokkaido Gastrointestinal Cancer Study Group


Japan: Ministry of Health, Labor and Welfare

Study ID:




Start Date:

April 2006

Completion Date:

March 2009

Related Keywords:

  • Metastatic Colorectal Cancer
  • irinotecan
  • S-1
  • Oxaliplatin
  • l-leucovorin
  • Fluorouracil
  • Metastatic colorectal cancer
  • phase III
  • Colorectal Neoplasms