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

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

Campto, Topotesin

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

TS-1

L-Plat

Isovorin

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.

5-FU

Yoshito Komatsu, MD, PhD

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).

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

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

Irinotecan Combined With S-1( IRIS ) Followed by mFOLFOX6 Regimen Versus mFOLFOX6 Followed by IRIS Regimen in Advanced Colorectal Cancer

Hokkaido University Hospital

Hokkaido Gastrointestinal Cancer Study Group

q00 mg/m2, IV (in the vein) on day 1,15 of each 28 day cycle.

80 mg/m2, PO (oral) on day 1\~14 of each 28 day cycle.

Yoshito Komatsu, MD.PhD

To assess the usefulness of irinotecan plus S-1 therapy based on the antitumor effect and survival period. by performing a phase II study of this combination in patients with inoperable or with postoperative colorectal cancer.

A multicenter Open-label, single-arm, phase II clinical trial is conducted on patients with histological stage IV colorectal cancer given irinotecan plus S-1. The usefulness of this regimens as 1st line therapy for colorectal cancer was evaluated by the disease-free survival rate (DFR), overall survival rate (OS), incidence and severity of adverse event.

Phase II Study of Oral S-1 Plus Irinotecan (IRIS) in Patients With Advanced Colorectal Cancer

Phase II Study of Oral S-1 Plus Irinotecan in Patients With Advanced Colorectal Cancer: Hokkaido Gastrointestinal Cancer Study Group HGCSG0302

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
IRIS Followed by mFOLFOX6 or the Reverse Sequence in Advanced Colorectal Cancer	NCT00316745	Metastatic Colo...	Campto, Topotes... TS-1 L-Plat Isovorin 5-FU	18 Years - 75 Years	Hokkaido Gastrointestinal Cancer Study Group
Phase II Study of Oral S-1 Plus Irinotecan (IRIS) in Patients With Advanced Colorectal Cancer	NCT00209651	Colorectal Canc...	Campto, Topotes... TS-1	18 Years - 75 Years	Hokkaido Gastrointestinal Cancer Study Group

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