IRIS Followed by mFOLFOX6 or the Reverse Sequence in Advanced Colorectal Cancer - Full Text View

Sponsors and Collaborators:	Hokkaido Gastrointestinal Cancer Study Group Hokkaido University Hospital
Information provided by:	Hokkaido Gastrointestinal Cancer Study Group
ClinicalTrials.gov Identifier:	NCT00316745

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 III

MedlinePlus related topics: Cancer Colorectal Cancer

Drug Information available for: Leucovorin Calcium Citrovorum factor Folinic acid calcium salt pentahydrate Leucovorin Irinotecan Irinotecan hydrochloride Fluorouracil Oxaliplatin S 1 (Combination)

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	Irinotecan Combined With S-1( IRIS ) Followed by mFOLFOX6 Regimen Versus mFOLFOX6 Followed by IRIS Regimen in Advanced Colorectal Cancer

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
1: Active Comparator mFOLFOX6 （　→　IRIS ( Irinotecan and S-1) ）	Drug: L-Plat Oxaliplatin (85mg/m2) Day 1, 15 Drug: Isovorin l-leucovorin (200mg/m2) Day 1, 15 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.
2: Experimental IRIS ( Irinotecan and S-1 ) 　→　mFOLFOX6	Drug: Campto, Topotesin 100 mg/m2, IV (in the vein) on day 1,15 of each cycle. Drug: TS-1 S-1 Day1~14, everyday P.O.(Day 15~28 rest)

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:

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.

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Contacts and Locations

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

Locations

Japan, Hokkaido
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

Study ID Numbers:	HGCSG0601, IFOX study
Study First Received:	April 19, 2006
Last Updated:	October 31, 2007
ClinicalTrials.gov Identifier:	NCT00316745
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

Study placed in the following topic categories:

Digestive System Neoplasms
Gastrointestinal Diseases
Colonic Diseases
Irinotecan
Leucovorin
Intestinal Diseases
Rectal Diseases

Intestinal Neoplasms
Oxaliplatin
Digestive System Diseases
Fluorouracil
Gastrointestinal Neoplasms
Colorectal Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Vitamin B Complex
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Growth Substances
Physiological Effects of Drugs
Enzyme Inhibitors

Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Vitamins
Micronutrients
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009