IRIS Followed by mFOLFOX6 or the Reverse Sequence in Advanced Colorectal Cancer
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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 |
- PFS of 1st line treatment [ Time Frame: 2-years ]
- 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 |
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.
-
Contacts and Locations| Japan | |
| Hokkaido University Hospital (Hokkaido University Graduate School of Medicine / School of Medicine) | |
| Sapporo, Hokkaido, Japan, 060-8638 | |
| 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 May 16, 2013