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

Primary Purpose

Metastatic Colorectal Cancer

Status
Suspended
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Campto, Topotesin
TS-1
L-Plat
Isovorin
5-FU
Sponsored by
Hokkaido Gastrointestinal Cancer Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Colorectal Cancer focused on measuring irinotecan, S-1, Oxaliplatin, l-leucovorin, Fluorouracil, Metastatic colorectal cancer, phase III

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: Patients receiving blood transfusion, blood derivatives or granulocyte-colony stimulating factor within 7days prior to entering the study. Patients can not have oral intake Patients receiving Flucytosine treatment Patients with severe pleural effusion or ascites. Patients who have brown brain metastasis Patients with diarrhea 4 or more times per day Patients with active gastrointestinal bleeding. Patients with intestinal obstruction Patients with active infection. Patients with serious pulmonary disease (such as interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema) 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). Patients with significant cardiac disease. Patients with active multiple cancer. Patients with neuropathy ≥ grade 2 Patients who are pregnant, are of childbearing potential, or breast-feeding. Patients with severe mental disorder. Patients with a history of serious allergic reaction. Judged to be ineligible for this protocol by the investigation. -

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

1

2

Arm Description

mFOLFOX6 ( → IRIS ( Irinotecan and S-1) )

IRIS ( Irinotecan and S-1 ) → mFOLFOX6

Outcomes

Primary Outcome Measures

PFS of 1st line treatment

Secondary Outcome Measures

OS
objective tumor response
PFS of 2nd line treatment
safety

Full Information

First Posted
April 19, 2006
Last Updated
October 31, 2007
Sponsor
Hokkaido Gastrointestinal Cancer Study Group
Collaborators
Hokkaido University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00316745
Brief Title
IRIS Followed by mFOLFOX6 or the Reverse Sequence in Advanced Colorectal Cancer
Official Title
Irinotecan Combined With S-1( IRIS ) Followed by mFOLFOX6 Regimen Versus mFOLFOX6 Followed by IRIS Regimen in Advanced Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2007
Overall Recruitment Status
Suspended
Why Stopped
Because of approval of Bevacizumab, it was difficult to perform clinical study in 1st line setting.
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hokkaido Gastrointestinal Cancer Study Group
Collaborators
Hokkaido University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Colorectal Cancer
Keywords
irinotecan, S-1, Oxaliplatin, l-leucovorin, Fluorouracil, Metastatic colorectal cancer, phase III

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
mFOLFOX6 ( → IRIS ( Irinotecan and S-1) )
Arm Title
2
Arm Type
Experimental
Arm Description
IRIS ( Irinotecan and S-1 ) → mFOLFOX6
Intervention Type
Drug
Intervention Name(s)
Campto, Topotesin
Other Intervention Name(s)
Irinotecan
Intervention Description
100 mg/m2, IV (in the vein) on day 1,15 of each cycle.
Intervention Type
Drug
Intervention Name(s)
TS-1
Other Intervention Name(s)
S-1
Intervention Description
S-1 Day1~14, everyday P.O.(Day 15~28 rest)
Intervention Type
Drug
Intervention Name(s)
L-Plat
Other Intervention Name(s)
Oxaliplatin
Intervention Description
Oxaliplatin (85mg/m2) Day 1, 15
Intervention Type
Drug
Intervention Name(s)
Isovorin
Other Intervention Name(s)
l-leucovorin
Intervention Description
l-leucovorin (200mg/m2) Day 1, 15
Intervention Type
Drug
Intervention Name(s)
5-FU
Other Intervention Name(s)
Fluorouracil
Intervention Description
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.
Primary Outcome Measure Information:
Title
PFS of 1st line treatment
Time Frame
2-years
Secondary Outcome Measure Information:
Title
OS
Time Frame
4-years
Title
objective tumor response
Time Frame
1-year
Title
PFS of 2nd line treatment
Time Frame
1-year
Title
safety
Time Frame
4-years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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: Patients receiving blood transfusion, blood derivatives or granulocyte-colony stimulating factor within 7days prior to entering the study. Patients can not have oral intake Patients receiving Flucytosine treatment Patients with severe pleural effusion or ascites. Patients who have brown brain metastasis Patients with diarrhea 4 or more times per day Patients with active gastrointestinal bleeding. Patients with intestinal obstruction Patients with active infection. Patients with serious pulmonary disease (such as interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema) 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). Patients with significant cardiac disease. Patients with active multiple cancer. Patients with neuropathy ≥ grade 2 Patients who are pregnant, are of childbearing potential, or breast-feeding. Patients with severe mental disorder. Patients with a history of serious allergic reaction. Judged to be ineligible for this protocol by the investigation. -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoshito Komatsu, MD, PhD
Organizational Affiliation
Hokkaido Gastrointestinal Cancer Study Group
Official's Role
Study Chair
Facility Information:
Facility Name
Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine)
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
060-8638
Country
Japan

12. IPD Sharing Statement

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

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