non-small-cell lung cancer
Conditions
Interventions
Docetaxel alone administered by 3 consecutive weekly infusions
Cispatin and docetaxel administered by 3 consecutive weekly infusions
Sponsors
Japan Clinical Oncology Group(JCOG)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) histologically or cytologocally 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 platinum(bolus infusion)-containing combination chemotherapy 6) No prior chemothrapy(containing gefitinib) for non-small cell lung cancer or other neoplasms 7) No prior surgery within 4weeks before enrollment 8) No prior radiotherapy for primary tumor 9) No prior radiotherapy for metastatic lesions within 2weeks before enrollment 10) Adequate organ function 11) Signed informed consent
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 10) Interstitial pneumonia/ Pulmonary fibrosis 11) Hypersensitivity for polysolbate 80 12) Systemic administartion of corticosteroids
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| overall survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Toxicity, Progression-free survival, Response rate, Symptom score | — |
Countries
Japan
Contacts
Public ContactHiroko Tsukada, MD
JCOG0207 Coordinating Office Department of internal medicine, Niigata Cancer Center Hospital
Outcome results
None listed