colorectal cancer colorectal cancer
Conditions
Interventions
Sponsors
Komatsu Yoshito
Hokkaido Gastrointestinal Cancer Study Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 20-85 years old 2. Histologically confirmed colorectal adenocarcinoma 3. ECOG PS 0 or 1 4. Documented disease progression 90days or more after the start of 1st-line chemotherapy containing anti-EGFR antibodies, oxaliplatin and fluoropyrimidines. 5. Adequate major organ and hematological functions within 14days before registration 6. Expected survival time 3 months or more at the registration 7. With documented informed consent
Exclusion criteria
Exclusion criteria: 1. Symptomatic CNS invasion and/or brain metastases 2. Uncontrollable infections 3. Uncontrollable diarrhea, anorexia or nausea 4. Uncontrollable hypertension 5. Symptomatic plural effusion or ascites 6. Inability of oral intake 7. Radiation to all lesions 8. UGT1A1 *6 homo, *28 homo, or *6 and *28 double hetero 9. History of other malignancies within 5 years (except for curative resection of carcinoma in situ) 10. Pregrant women 11. Irinotecan-containing regimen as 1st-line therapy 12. Following status: Gastrointestinal or abdominal inflammations Gastrointestinal or other bleeding Hemorrhagic diathesis, coagulopathy, or treated with anticoagulants Thromboembolism No wound healing from major surgery 13. Administration of aflibercept-containing medications 14. Dihydropyrimidine dehydrogenase deficiency 15. Interstitial pneumonia or pulmonary fibrosis 16. Participation in the clinical trial is determined as unsuitable
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival rate at six months (PFS rate at 6 months) | — |
Secondary
| Measure | Time frame |
|---|---|
| overall survival, progression-free survival, response rate, disease control rate, adverse events and relative dose intensity for each drug | — |
Contacts
Public ContactKazuaki Harada
Hokkaido University Hospital
Outcome results
None listed