Pulmonary metastases from colorectal cancer
Conditions
Interventions
Chemotherapy with XELOX(capecitabine+oxaliplatin)+bevacizumab Treatment repeats every 21days for up to 4courses
Sponsors
Osaka International Cancer Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Histologically proven colon or rectum cancer 2.Palpable pulmonary metastases from colorectal cencer,no prior chemotherapy,surgery was done only for resect primary tumor,and passed 4weeks In case of metachronous,no prior chemotherapy to pulmonary metastases,adjuvant chemotherapy completed before more than 6months(except oxaliplatin and bevacizumab) 3.Wriiten informed consent 4.Age:20-80 years old 5.Performance status 0-1 6.A predicted life expancy of at least 3months 7.With sufficient bone marrow,renal or hepatic function WBC:>=3000/mm3(neutrocyte=>1500/mm3) Platelet:=>100,000/mm3 Hemoglobin:=>10.0g/dl Total bilirubin:=>2.0mg/dl AST(GOT):=<100IU/L ALT(GPT):=<120IU/L Serum creatinin:=<1.5mg/dl
Exclusion criteria
Exclusion criteria: 1.Body cavity fluid,and it needs drainage 2.Brain metastases or brain cancer 3.With active double cancers 4.With unresectable metastases except for pulmonary metastases 5.With cerebrovascular disease,or history of cerebrovascular disease less than 1year prior to entry 6.Surgery,biopsy with skin incision,or traumatic injury with suture less than 4weeks prior to entry 7.With thrombosis,or history of thrombosis less than 1 year prior to entry 8.Trend of bleeding or coagulation disorder 9.With uncontrolable ulcer 10.With gastrointestinal perforation,or history of gastrointestinal perforation less than 1 year prior to entry 11.With bone fracture 12.With renal disfunction,or proteiun uria 2+ less than 2 weeks prior to entry 13.With uncontrolable hypertension 14.With cardiovascular disease,or myocardinal dysfunction less than 1year prior to entry 15.History of hypersensitivity for test drugs 16.History of adverse event caused by fluoropyrimidine drugs 17.With uncontrorable diarrhea 18.With interstitial pneumonia or pulmonary fibrosis 19.With uncontrorable infection 20.With carcinomatous pleuritis 21.Nursing or pregnant females,or females who are planning to pregnancy 22.Male who are plannning to pregnancy 23.Participation in other clinical trial less than 4weeks prior to entry 24.History of bevacizumab or oxaliplatin use 25.Any other serious medical consition that would preclude study treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| safety | — |
Secondary
| Measure | Time frame |
|---|---|
| response rate,resection rate of pulmonary metastases,protcol treatment accomplish rate, progression free survival | — |
Countries
Japan
Contacts
Public ContactYasuko Nishiawa
Osaka International Cancer Institute Department of pathology
Outcome results
None listed