Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
European Organisation for Research and Treatment of Cancer - EORTC
OBJECTIVES: Primary * Compare the tolerability (in terms of drug delivery and toxicity) of neoadjuvant vs adjuvant chemotherapy comprising cisplatin and pemetrexed disodium in patients with resectable stage IB or II non-small cell lung cancer. Secondary * Determine the overall toxicity of this regimen in these patients. * Determine the progression-free and overall survival of patients treated with this regimen. * Determine the overall clinical response rate, pathologic complete response, and resectability rate in patients treated with neoadjuvant chemotherapy. * Determine the surgical morbidity and mortality of patients treated with these regimens. * Determine the fraction of patients in the adjuvant arm that receives chemotherapy. OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to institution, histological subtype (squamous vs nonsquamous) and clinical stage (IB vs II). Patients are randomized to 1 of 2 treatment arms. * Arm I (neoadjuvant chemotherapy): Patients receive cisplatin IV over 3-6 hours and pemetrexed disodium IV on day 1. Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Four to six weeks after completion of chemotherapy, patients undergo surgery. * Arm II (adjuvant chemotherapy): Patients undergo surgery. Beginning 4-8 weeks after surgery, patients receive cisplatin and pemetrexed disodium as in arm I. After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter. PROJECTED ACCRUAL: A total of 132 patients will be accrued for this study.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted