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

Last updated: October 31, 2007
Sponsor: Hokkaido Gastrointestinal Cancer Study Group
Overall Status: Suspended

Phase

3

Condition

Metastatic Cancer

Colorectal Cancer

Treatment

N/A

Clinical Study ID

NCT00316745
HGCSG0601
IFOX study
  • Ages 18-75
  • All Genders

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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Histological diagnosis of colorectal cancer. 2) Age: 18 - 75 years. 3) No priorchemotherapy 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/mm3and Neutrophil ≧2,000/mm3. Hb ≧10.0 g/dl. Platelet count ≧100,000/mm3. AST and ALT ≦2.5times 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 awritten informed contact document.

Exclusion

Exclusion Criteria:

  1. Patients receiving blood transfusion, blood derivatives or granulocyte-colonystimulating 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, pulmonaryfibrosis, pulmonary emphysema)

  11. Patients with serious complications (such as intestinal paralysis, intestinalobstruction, interstitial pneumonia or pulmonary fibrosis, uncontrolled diabetesmellitus, 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.

Study Design

Total Participants: 200
Study Start date:
April 01, 2006
Estimated Completion Date:
March 31, 2009

Study 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

Connect with a study center

  • Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine)

    Sapporo, Hokkaido 060-8638
    Japan

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.