Randomized phase II study of mFOLFOX6 versus TS-1/CPT-11 in patients with advanced/recurrent colorectal cancer

UMIN ID: UMIN000000786

Registered date:09/08/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Patients with advanced and/or recurrent colorectal cancer
• Date of first enrollment: 2007/07/01
• Target sample size: 70
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Group A:mFOLFOX6 Day 1 day 2 day 14 L-OHP 2HR l-LV 200mg/m2 5-FU 2,400mg/m2 civ 2HR 46HR ------------- | 5-FU 400mg/m2 iv Rapid
Group B:TS-1/CPT-11 CPT-11 80 mg/m2 CPT-11 80 mg/m2 1.5 hours 1.5 hours TS-1 40-60 mg/m2 | | | | Day 1 day 15 day 21 day 35 One course takes 35 days (5 weeks).

Outcome(s)

• Primary Outcome: Response Rate(RECIST)
• Secondary Outcome: Overall Survival, Progression Free Survival, Adverse Events, Incidence of Recruitement

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: 1)Pulmonary fibrosis or Interstitial Pneumonitis by chet X-ray examination 2)Cavity fluid which needs drainage 3)with active double cancer 4)with peripheral nerve disorder 5)with intestinal paralysis or intestinal obstruction 6)under watery diarrhea 7)uncontrolled DM 8)with mental disorder which disturbs registration to this study 9)with infectious disease 10)patients who receive steroids treatment 11)Cardiac failure, liver dysfunction, or renal dysfunction which disturb Registration to this study 12)with brain metastasis and its symptom 13)pregnant women or women who like to be pregnant 14)history of severe allergy against drug 15)patients receiving Atazanabil 16)doctor's dicision not to be registered to this study

Related Information

• Primary Sponsor: OGSG
• Source(s) of Monetary Support: NPO Osaka Chinical Study Supporting Organization