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

This study has suspended participant recruitment.
(Because of approval of Bevacizumab, it was difficult to perform clinical study in 1st line setting.)
Sponsor:
Collaborator:
Hokkaido University Hospital
Information provided by:
Hokkaido Gastrointestinal Cancer Study Group
ClinicalTrials.gov Identifier:
NCT00316745
First received: April 19, 2006
Last updated: October 31, 2007
Last verified: October 2007
  Purpose

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).


Condition Intervention Phase
Metastatic Colorectal Cancer
Drug: Campto, Topotesin
Drug: TS-1
Drug: L-Plat
Drug: Isovorin
Drug: 5-FU
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Irinotecan Combined With S-1( IRIS ) Followed by mFOLFOX6 Regimen Versus mFOLFOX6 Followed by IRIS Regimen in Advanced Colorectal Cancer

Resource links provided by NLM:


Further study details as provided by Hokkaido Gastrointestinal Cancer Study Group:

Primary Outcome Measures:
  • PFS of 1st line treatment [ Time Frame: 2-years ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: April 2006
Estimated Study Completion Date: March 2009
Arms Assigned Interventions
Active Comparator: 1
mFOLFOX6 ( → IRIS ( Irinotecan and 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
Experimental: 2
IRIS ( Irinotecan and S-1 ) → mFOLFOX6
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

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  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316745

Locations
Japan
Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine)
Sapporo, Hokkaido, Japan, 060-8638
Sponsors and Collaborators
Hokkaido Gastrointestinal Cancer Study Group
Hokkaido University Hospital
Investigators
Study Chair: Yoshito Komatsu, MD, PhD Hokkaido Gastrointestinal Cancer Study Group
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00316745     History of Changes
Other Study ID Numbers: HGCSG0601, IFOX study
Study First Received: April 19, 2006
Last Updated: October 31, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Hokkaido Gastrointestinal Cancer Study Group:
irinotecan
S-1
Oxaliplatin
l-leucovorin
Fluorouracil
Metastatic colorectal cancer
phase III

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Fluorouracil
Oxaliplatin
Irinotecan
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes

ClinicalTrials.gov processed this record on April 22, 2014