non-small-cell lung cancer
Conditions
Interventions
A : 3-weekly docetaxel alone
B : Weekly docetaxel+cisplatin combination
Sponsors
Japan Clinical Oncology Group(JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) histologically or cytologically proven non-small-cell lung cancer 2) stage IV, or stage III disease ineligible for definitive radiotherapy 3) 70 years or older 4) ECOG PS 0-1 5) Ineligible for standard cisplatin(bolus infusion)-containing combination chemotherapy 6) Measurable lesions not required 7) No prior chemotherapy(containing molecular targeted drug) for non-small cell lung cancer or other neoplasms 8) No prior surgery within 4 weeks before enrollment 9) No prior radiotherapy for primary tumor 10) No prior radiotherapy for metastatic lesions within 2 weeks before enrollment 11) No prior red blood cell transfusions within 2 weeks before enrollment 12) Adequate organ function 13) Signed informed consent 14) Assessment of baseline Symptom Score done before enrollment
Exclusion criteria
Exclusion criteria: 1) Symptomatic brain metastasis 2) Active another neoplams 3) Severe SVC syndrome 4) Massive pericardial, pleural effusion, or ascites 5) Bone metastasis emergent for palliative radiotherapy or surgery 6) Uncontrollable systemic hypertension 7) Heart failure, Unstable angina, Myocardial infarction within 6 months 8) Uncontrollable diabetes 9) Active infection other than viral hepatitis 10) Hepatitis B virus infection 11) Interstitial pneumonia/ Pulmonary fibrosis 12) Hypersensitivity for polysolbate 80 13) Systemic administartion of corticosteroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| adverse events, progression-free survival, response rate, complete response rate, Symptom Score | — |
Countries
Japan
Contacts
Public ContactTeduya Abe
JCOG0803/WJOG4307L Coordinating Office Department of internal medicine, Niigata Cancer Center Hospital
Outcome results
None listed