A phase II trial of TAS-102 in combination with cetuximab for patients with RAS wild-type metastatic colorectal cancer refractory to previous anti-EGFR antibodies(WJOG8916G)
- Conditions
- Metastatic RAS wild type colorectal cancer which has become refractory or there was intolerance to chemotherapies (fluoropyrimidine, irinotecan, oxaliplatin) and bevacizumab, and refractory to anti-epidermal growth factor receptor(EGFR) antibodies
- Registration Number
- JPRN-UMIN000027210
- Lead Sponsor
- West Japan Oncology Group
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 55
Not provided
1) Previous grade 3/4 hypersensitivity reaction to Cmab 2) Another malignancy with less than 5 disease-free years 3) Presence of active local or systemic infection under treatment 4) Positive for Hepatitis B surface antigen 5) Radiographic evidence of severe pulmonary fibrosis or interstitial pneumonia on Computed Tomography 6) Symptomatic brain and/or leptomeningeal metastases which needs treatment 7) Serious complications 8) Clinically significant mental or psychological disorder 9) Patients requiring continuous treatment with systemic steroids 10) Females who are pregnant, breastfeeding, or with a positive pregnancy test or males and females of reproductive potential unwilling to use adequate contraception 11) Patients whose participation in the trial was judged to be inappropriate by the attending doctor
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method disease control rate
- Secondary Outcome Measures
Name Time Method overall survival , progression free survival , response rate , safety