NIPH Clinical Trials Search

UMIN ID: UMIN000000770

Registered date:22/07/2007

Randomized pilot study comparing safety of irinotecan+S-1(IRIS)+bevacizumab and mFOLFIRI+bevacizumab for metastatic colorectal cancer (T-CORE0702)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studied1st line or 2nd line therapy for unresectable colorectal cancer
Date of first enrollment2007/07/01
Target sample size60
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)FOLFIRI + bevacizumab consisted of bevacizumab 5mg/kg as a 90-minute infusion, then, l-LV 200 mg/m2 as a 2-hour infusion, and irinotecan 150 mg/m2 given as a 90-minute infusion, followed by bolus FU 400 mg/m2 and a 46-hour infusion FU 2,400 mg/m2, repeated every 2 weeks. IRIS + bevacizumab consisted of bevacizumab 7.5mg/kg as a 90-minute infusion, then, irinotecan 150 mg/m2 given as a 90-minute infusion, followed by oral S-1 (40 mg/m2) twice daily 14 days (day 3 to 16) followed by 5 days rest, repeated every 3 weeks.


Primary Outcomesafety
Secondary Outcomeresponse rate and progression free survival (PFS)

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteriaThe exclusion criteria were previously abdominal radiotherapy; active double cancers, with complication of paralytic intestine, bowel obstraction (ileus), uncontrolled diabtes mellitus, uncontrolled hypertention, unstable angina pectoris, liver cirrhosis, interstitial pneumonitis, pulmonary fibrosis or high-grade pulmonary emphysema; previous history of herpersensitivity against S-1; massive pleural or peritoneal effusion; diarrhea, uncontrolled peptic ulcer; current or previous (within one year) history of GI perforation; primary or metastatic brain tumor by image examination; current or previous (within one year) history of cerebrovascular attach; symptomatic or asymptomatic but treated heart disease; any surgical treatmentsincluding skin-open biopsy, trauma surgery and other more intensive surgery within 4 weeks (except for a CV-port procedure one week or more earlier) or aspiration biopsy within one week; bleeding tendency, coagulation abnormality; anti-platelets therapy (including aspirin and NSAIDS) for chronic inflammatory disease such as rheumatoid arthritis; irinotecan used pevious adjuvant chemotherapy

Related Information


public contact
Name Shunsuke Kato
Address 4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan Japan
Telephone 022-717-8599
Affiliation NPO T-CORE (Tohoku Clinical Oncology Research and Education Society) Office
scientific contact
Name Chikashi Ishioka
Address 4-1 Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan Japan
Telephone 022-717-8543
Affiliation Institute of Development, Aging and Cancer, Tohoku University Department of Clinical Oncology