A Phase 3 interventional study of Campto, Topotesin and TS-1 in Metastatic Colorectal Cancer, sponsored by Hokkaido Gastrointestinal Cancer Study Group. Suspended at 1 site in Japan. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2007-11-01.
Sponsored by Hokkaido Gastrointestinal Cancer Study Group · Phase 3, Interventional, and Treatment
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
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,458 are open to participants now.
This study's planned enrollment of 200 is above the median of 77 across 4,122 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Hokkaido Gastrointestinal Cancer Study Group is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Judged to be ineligible for this protocol by the investigation.
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mFOLFOX6 ( → IRIS ( Irinotecan and S-1) )
Drug: L-Plat · Drug: Isovorin · Drug: 5-FU
IRIS ( Irinotecan and S-1 ) → mFOLFOX6
Drug: Campto, Topotesin · Drug: TS-1
100 mg/m2, IV (in the vein) on day 1,15 of each cycle.
Also known as: Irinotecan
S-1 Day1\~14, everyday P.O.(Day 15\~28 rest)
Also known as: S-1
Oxaliplatin (85mg/m2) Day 1, 15
Also known as: Oxaliplatin
l-leucovorin (200mg/m2) Day 1, 15
Also known as: l-leucovorin
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.
Also known as: Fluorouracil
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
This study is suspended, as verified in Oct 2007. You cannot join it, but the record below documents what was studied.
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Hokkaido Gastrointestinal Cancer Study Group