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

NCT ID: NCT00316745

Last Updated: 2007-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2009-03-31

Brief Summary

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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

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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

Conditions

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Metastatic Colorectal Cancer

Keywords

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irinotecan S-1 Oxaliplatin l-leucovorin Fluorouracil Metastatic colorectal cancer phase III

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

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

Group Type ACTIVE_COMPARATOR

L-Plat

Intervention Type DRUG

Oxaliplatin (85mg/m2) Day 1, 15

Isovorin

Intervention Type DRUG

l-leucovorin (200mg/m2) Day 1, 15

5-FU

Intervention Type DRUG

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.

2

IRIS ( Irinotecan and S-1 ) → mFOLFOX6

Group Type EXPERIMENTAL

Campto, Topotesin

Intervention Type DRUG

100 mg/m2, IV (in the vein) on day 1,15 of each cycle.

TS-1

Intervention Type DRUG

S-1 Day1\~14, everyday P.O.(Day 15\~28 rest)

Interventions

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Campto, Topotesin

100 mg/m2, IV (in the vein) on day 1,15 of each cycle.

Intervention Type DRUG

TS-1

S-1 Day1\~14, everyday P.O.(Day 15\~28 rest)

Intervention Type DRUG

L-Plat

Oxaliplatin (85mg/m2) Day 1, 15

Intervention Type DRUG

Isovorin

l-leucovorin (200mg/m2) Day 1, 15

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Irinotecan S-1 Oxaliplatin l-leucovorin Fluorouracil

Eligibility Criteria

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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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Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hokkaido University Hospital

OTHER

Sponsor Role collaborator

Hokkaido Gastrointestinal Cancer Study Group

OTHER

Sponsor Role lead

Principal Investigators

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Yoshito Komatsu, MD, PhD

Role: STUDY_CHAIR

Hokkaido Gastrointestinal Cancer Study Group

Locations

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

Sapporo, Hokkaido, Japan

Site Status

Countries

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Japan

Other Identifiers

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IFOX study

Identifier Type: -

Identifier Source: secondary_id

HGCSG0601

Identifier Type: -

Identifier Source: org_study_id