A phase III study comparing carboplatin plus pemetrexed followed by maintenance pemetrexed with docetaxel in elderly patients with advanced non-squamous non-small-cell lung cancer (JCOG1210/WJOG7813L CBDCA/PEM vs DOC Phase III)

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2013
INTERVENTION: A: Docetaxel (60 mg/m2) given on day 1 every 3 weeks B: Carboplatin (AUC 5) plus pemetrexed (500 mg/m2) given on day 1 every 3 weeks. If the patients do not develop disease progression, continuation maintenance of pemetrexed (500 mg/m2) is given on day 1 every 3 weeks until disease progression. CONDITION: Elderly patients with advanced non‐squamous non‐small‐cell lung cancer PRIMARY OUTCOME: Overall survival SECONDARY OUTCOME: Progression‐free survival, response rate, symptom score, toxicity INCLUSION CRITERIA: 1) Histologically or cytologically confirmed advanced non‐squamous non‐small‐cell lung cancer 2) Clinical stage IIIB (not amenable to curative radiation), IV or recurrent disease 3) 75 years of age or older 4) Performamne status of 0 or 1 5) Regardless of the presence of mesurable lesions 6) Without symptomatic central nervous system metastases 7) No prior chemotherapy or radiotherapy for any other cancers 8) Withour grade 3 or more SVC syndrome, pericardial or pleural effusion 9) No prior surgery accompanied with general anethesia within 28 days before registration 10) No prior palliative radiotherapy for metastatic lesion within 14 days before registration 11)Adequate organ funcion 12) Written informed consent
Epistemonikos ID: 9fa7f1e0450ee130660beeb76d61adb281ea9098
First added on: Aug 22, 2024