Colorectal cancer
Conditions
Interventions
The investigators choose the treatment A or Barbitrarily. A: FOLFOX + panitumumab B: FOLFIRI + panitumumab Repeat every 14 days until meeting the withdrawal criteria.
Sponsors
Tokyo Medical and Dental University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Coloretal cancer (adenocarcinoma) 2) Unresectable 3) KRAS wild type 4) Age: 20-80 years old 5) ECOG performance status: 0-1 6) >=1 measurable lesion (at <=30 days prior to enrollment) 7) No prior chemotherapy and radiation thrpy (ex. adjuvant chmotherpy completed <=180 days prior to enrollmet) 8) Adequate organ functions as listed below (at <=14 days prior to enrollment) i) WBC: 3,000/mm3 to 12,000/mm3 ii) Neutrophl: >=1,500/mm3 iii) Plt: >=100,000/mm3 iv) Hb: >=9.0g/dL v) T-Bil: <=1.5mg/dL vi) AST(GOT): <=100*IU/L vii) ALT(GPT): <=100*IU/L *patients with liver metastas: <=200IU/L viii) Creatinine: <=1.2mg/dL 9) Expected survival >=3 months 10) Written informed concent
Exclusion criteria
Exclusion criteria: 1) Prior severe drug allergy 2) Synchronous and/or metachronous multiple cancers 3) Severe bowel stenosis by the primary tumor (ex. after colostomy) 4) Prior adjuvant chemotherapy with oxaliplatin containing regimen 5) Surgical procedure within 28 days prior to enrollment (ex. venous reservoirs implant, colostomy) 6) Severe comorbidity: - severe pulmonary dysfunction - Uncontrolled DM - Uncontrolled HT - severe cardiovascular disease - Cirrhosis and liver failure - Renal failure 7) Sensory neuropathy 8) Severe diarrhea 9) Active infection 10) Symptomatic pleural effusion or ascites 11) Contraindications to 5-FU, l-LV, panitumumab, L-OHP or CPT-11 12) Concerning pregnancy 13) The investigator considers not suitable for the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall response rate (ORR) | — |
Secondary
| Measure | Time frame |
|---|---|
| - Safety - Progression free survival (PFS) - Overall survival (OS) - Time to progression (TTP) - Time to treatment failure (TTF) - Disease control rate - R0-resection rate - Histological investigation of the post-treatment liver tissues - Correlation between clinico-pathological factors and efficacy | — |
Countries
Japan
Contacts
Public ContactKenichi Sugihara, M.D., PhD
Tokyo Medical and Dental University, Graduate School Dept. of Surgical Oncology
Outcome results
None listed