Colorectal cancer
Conditions
Interventions
None listed
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. More than 180 days after the last chemotherapy . 6) No recurrence on chest and abdominal CT or MRI within 4 weeks before enrollment. 7) ECOG performance status 0-1 8)Vital organ functions (listed below) are preserved within 1 week prior to entry. 9) 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. 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 |
|---|---|
| Evaluation of the ability and reproducibility of risk classification by the prognostic index. | — |
Countries
Japan
Contacts
Public ContactShinichiro Nakamura
West Japan Oncology Group WJOG datacenter
Outcome results
None listed