advanced/recurrent colon cancer patients with RAS wild-type tumors who cannot undergo intensive therapy
Conditions
Interventions
S-1 was administered orally on days 1-14 of a 21-day cycle cetuximab 400mg/m2 followed by weekly 250mg/m2
Sponsors
NHO HOKKAIDO CANCER CENTER Division of Gastroenterology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Histologically confirmed colorectal cancer. 2) unresectable primary lesion/distant metastasis/lymph node metastasis. In the case of recurrence, no treatment for the first recurrence leision after operation. 3) RAS wild-type. 4) Inappropriate for FOLFIRI, FOLFOX 5) Measurable leision by RECIST.(Ver.1.1) 6) No past history of chemotherapy 7) No past history of radiation therapy 8) Age; more than 65 years old. Life expectancy of more than 3 months. 9) ECOG Performance status 0-2. 10) Patiens have enough organ function for study treatment within 14 days before enrollment; 1 Hb>=9.0g/dL 2 WBC>=3,000/mm3, <12,000/mm3. 3 Neu>=1,500/mm3. 4 PLT>=10.0x104/mm3. 5 Total Bilirubin<=1.5mg/dL. 6 AST/ALT<=100 7 Creatinine<=1.2mg/dL. 8 Creatinine clearance estimation >=50mL/min 11) Oral intake is possible 12) Normal cardiac function confirmed by cardiac electro gram within 28 days of registration 13) Written informed consent
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS:Progression Free Survival | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTAMOTSU SAGAWA
NHO HOKKAIDO CANCER CENTER Division of Gastroenterology
Outcome results
None listed