colorectal cancer
Conditions
Interventions
After 8 cycles of modified FOLFOX 6 with bevacizmab, patients receive sLV5FU2 with bevacizumab (until 8 cycles are completed or disease progression). And then, patients receive modified FOLFOX6 with b
Sponsors
Mlnlstry of health, Labour and Welfare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) unresectable or recurrent colorectal cancer. 2) Histologically documented adenocarcinoma, mucinous carcinoma, or signet ring cell carcinoma of the colon or rectum. In the recurrent case, histology of the primary site must have been histologically confirmed in the past. Additiona histological confirmation of metastatic lesion or recurrent site is not necessary. 3) Age more than 20years and less than 75 years. 4) ECOG performance status of 0,1 or 2. 5) At least one measurable lesion based on the RECIST criterion. 6) No prior therapies for metastatic and/or recurrent disease. Prior adjuvant therapy is allowed if it is completed at least 24 weeks before registration. No neo-adjuvant chemotherapy is allowed. 7) Required baseline laboratory parameters (within 7 days before registration): Hb more than 8.0g/dl WBC more than 3000 and WBC less than 12000/ul Plt more than 100,000/ul T-Bil less than 1.5mg/dl GOT less than 100 IU/l GPT less than 100 IU/l Cre less than 1.5mg/dl 8) Signed informed consent of the patient for the registration.
Exclusion criteria
Exclusion criteria: 1) active other malignancies 2) history of the severe drug hypersensitivity 3) clinically significant infectious disease(body temperature less than 38.0 degrees) 4) severe complications (ileus, bowel obstruction, interstitial lung disease, pulmonary fibrosis, uncontrolled diabetes mellitus, heart failure, renal failure, hepatic failure and so on) 5) uncontrollable hypertension 6) urinary protein (more than 1+) 7) Patients who have abnormal findings on ECG and need any treatment (within 2 weeks before the registration.) 8) Moderate/severe pleural effusion or ascites 9) Symptomatic brain metastasis 10) Any significant bleedings 11) Evidence of bleeding diathesis 12) History of thoromboembolitic disease 13) Uncontrolled watery diarrhea. Watery colostomy output without trouble with patient's daily living is allowed. 14) Surgical procedure within 4 weeks before registration (the implanted central venous port is allowed.) 15) Patient who underwents the implantation of the central venous port within a day prior to start of study drugs. 16) Pregnant or lactating women, women who are capable of pregnancy or intend to get pregnant, men who don't intend to have protected intercourse. 17) Any other cases who are regarded as Inadequate for study enrollment by the attending doctors.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of adverse events Time to treatment failure Progression-free survival Overall survival The incidence of grade 3 neurotoxicity | — |
Countries
Japan
Contacts
Public ContactNatsuko OKITA
National Cancer Center Hospital Department of Internal Medicine
Outcome results
None listed