Phase II study of combination therapy with S-1 plus cetuximab in patients with EGFR positive KRAS wild type unresectable colorectal cancer, who had previously received on irinotecan, oxaliplatin and fluoropyrimidine(KSCC0901).
- Conditions
- Colorectal cancer
- Registration Number
- JPRN-UMIN000002475
- Lead Sponsor
- Kyushu Study group of Clinical Cancer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 39
Not provided
1) Severe bone marrow suppression 2) Severe infectious disease 3) Massive pleural effusion or ascites 4) Comorbidity or history of severe heart failure 5) Comorbidity or history of interstitial lung disease or pulmonary fibrosis 6) Paralytic or mechanical bowel obstruction 7) Jaundice 8)History of severe allergy 9)Impossible to evaluate disease by enhanced CT 10)Pregnant or lactating women or women of childbearing potential 11)Severe comorbidity (uncontrolable diabetes, hypertension, hypercarcemia etc) 12)Symptomatic brain metastasis 13)Simultaneous or metachronous double cancers 14)Patients who had received anti EGFR drug that include cetuximab. 15)Any other cases who are regarded as inadequate for study enrollment by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Progression free survival(PFS)
- Secondary Outcome Measures
Name Time Method ORR, OS, OS from first diagnosis, DCR, TTF, DI, safety, BRAF mutation