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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:
ClinicalTrials.gov Identifier:
NCT00316745
First Posted: April 21, 2006
Last Update Posted: November 1, 2007
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.
Collaborator:
Hokkaido University Hospital
Information provided by:
Hokkaido Gastrointestinal Cancer Study Group
  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
Intervention Model: Crossover Assignment
Masking: None (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00316745     History of Changes
Other Study ID Numbers: HGCSG0601
IFOX study
First Submitted: April 19, 2006
First Posted: April 21, 2006
Last Update Posted: November 1, 2007
Last Verified: October 2007

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
Oxaliplatin
Irinotecan
Camptothecin
Fluorouracil
Levoleucovorin
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antimetabolites
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antidotes
Protective Agents