colorectal cancer
Conditions
Interventions
After 8 cycles of mFOLFOX 6 plus bevacizumab, patients receive UFT/LV with bevacizumab (until 5 cycles are completed or disease progression). And then, patients receive modified FOLFOX6 plus bevacizum
Sponsors
Chiba Cancer Center Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) unresectable or recurrent colorectal cancer histologically diagnosted adenocarcinoma of the colon or rectum. 2) Age more than 20years and less than 75 years. 3) No prior therapies for metastatic and/or recurrent disease. Prior adjuvant therapy is allowed if it is completed at least 6 months before registration. 4) ECOG performance status of 0 or 1 . 5) Required baseline laboratory parameters (within 7 days before registration): WBC more than 4000 and WBC less than 12000/mm3 Neutrophils more than 2000/mm3 Plt more than 100,000/mm3 Hb more than 9.0g/dl GOT less than 100 IU/l GPT less than 100 IU/l T-Bil less than 1.5mg/dl Creatinine less than 1.5mg/dl 6) Signed informed consent of the patient for the registration.
Exclusion criteria
Exclusion criteria: 1) contraindication to 5-FU, oxaliplatin, UFT, calcium folinate, or bevacizumab. 2) moderate/severe pleural effusion, ascites or pericardial effusion. 3) brain metastases. 4) history of active other malignancies. 5) neuropathy. 6) history of thoromboembolitic disease. 7) uncontrollable Diabetes Mellitus or hypertension 8) interstitial lung disease, pulmonary fibrosis or severe pulmonary emphysema. 9) intestinal bleeding, ileus, bowel obstruction or uncontrolled peptic ulcer. 10) clinically significant infectious disease (body temperature more than 38.0 degrees) 11) urinary protein (more than 1+) 12) uncontrolled watery diarrhea. 13) pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant. 14) Any other cases who are regarded as inadequate for study enrollment by the attending doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease control survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival Overall survival The incidence of adverse events | — |
Countries
Japan
Contacts
Public ContactTadamichi Denda
Chiba Cancer Center Hospital Gastroenterology
Outcome results
None listed