A phase II study to evaluate the effectiveness of S-1 + Cetuximab for patients with advanced/recurrent colon cancer who cannot undergo intensive therapy
- Conditions
- advanced/recurrent colon cancer patients with RAS wild-type tumors who cannot undergo intensive therapy
- Registration Number
- JPRN-UMIN000018484
- Lead Sponsor
- HO HOKKAIDO CANCER CENTER Division of Gastroenterology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 57
Not provided
1) History of severe allergy 2) Active synchronous or metachronous malignancy 3) Severe infectious disease 4) Severe complications (interstitial lung disease or pulmonary fibrosis, heart failure, kidney failure, hepatic failure, uncontrolable diabetes, Jaundice) 5) Massive pleural effusion or ascites 6) Wattery diarrhea 7) Prior treatment of cetuximab or L-OHP or TS-1 8) Patients who is receiving Flucytosine 9) Symptomatic brain metastasis 10) Pregnant or lactating women or women of childbearing potential 11) Severe mental disorders 12) Systemic administration of steroid 13) Severe renal failure, or urinary protein (more than 2+). 14) Prior radiotherapy for primary and metastases leision. 15) History of allergy for L-OHP and other platinating agent 16) Sensory alteration or paresthesia interfering with function. 17) 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 PFS:Progression Free Survival
- Secondary Outcome Measures
Name Time Method Safety ORR:Overall Response Rate OS:Overall Survival ETS:Early Tumor Shrinkage DpR:Deepness of Response RDI:Relative Dose Intensity TTP:Time to progression TTF:Time to treatment failure