Colorectal cancer
Conditions
Interventions
Fluororacil/l-leucovorin plus oxaliplatin (mFOLFOX6)
Sponsors
West Japan Oncology Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Potentially curative R0 resection was performed for patients with lung metastases from colorectal cancer. 2) Initial lung metastasectomy. 3) Pathological findings should be as follows i)Histologically proven adenocarcinoma ii)Less than 4 metastases. iii)No pulmonary, hilar and mediastinal lymph node metastases. 4) Within 70 days after lung metastasectomy 5) No prior chemotherapy for advanced or metastatic disease. i)Adjuvant chemotherapy with only FU is allowed. ii)More than 180 days after the last chemotherapy . 6) No recurrence on chest and abdominal CT or MRI within 4 weeks before enrollment. 7) Age 20-75 years 8) ECOG performance status 0-1 9) Vital organ functions (listed below) are preserved within 1 week prior to entry. i)White blood cell count >= 3,000/mm3 and <= 12,000/mm3 ii) Platelets>=100,000/mm3 iii)Hemoglobin> =9.0g/dl iv)Total bilirbin> =1.5mg/dl v)AST and ALT<= 100IU/l vi)serum creatinine <= 1.5mg/dl 10) Written informed consent
Exclusion criteria
Exclusion criteria: 1)Adjuvant FU was terminated because of ADR. 2)Multiple cancer patient (within 5 years) 3)Transfusion or blood product or growth factor such as G-CSF less than 14 days prior to entry. 4)Have following severe complications. i)Bowel obstruction ii)Uncontrolable heart disease iii)Severe pulmonary fibrosis, interstitial lung disease, COPD iv)Uncontrolable hypertension v)Uncontrolable diabetes vi)Active peptic ulcer vii)Uncontrolable diarrhea viii)bleeding diathesis ix)HIV infection x)Active infectious disease 5)Systemic and continuous steroids medication. 6)Severe peripheral neuropathy. 7)History of the serious hypersensitivity for drugs 8)Hepatitis B virus infection 9)Clinically significant mental or psychological disease. 10)Not pregnant 11)Patient who is taking flucytosine, phenytoin or warfarin potassium continuously. 12)Other conditions not suitable for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 5-year survival rate | — |
Secondary
| Measure | Time frame |
|---|---|
| DFS, Safety, Site of relapse | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed