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

UMIN ID: UMIN000000770

Registered date:22/07/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: 1st line or 2nd line therapy for unresectable colorectal cancer
• Date of first enrollment: 2007/07/01
• Target sample size: 60
• Countries of recruitment: Japan
• Study type: Interventional

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.

Outcome(s)

• Primary Outcome: safety
• Secondary Outcome: response rate and progression free survival (PFS)

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: The 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

• Primary Sponsor: NPO T-CORE (Tohoku Clinical Oncology Research and Education Society)
• Source(s) of Monetary Support: NPO T-CORE (Tohoku Clinical Oncology Research and Education Society)