Phase III randomised trial of adjuvant chemotherapy with cisplatin plus docetaxel versus cisplatin plus gemcitabine in resected non-small cell bronchial carcinoma with quality of life as the primary objective

Background Adjuvant chemotherapy improves survival of completely resected non-small cell lung cancer (NSCLC). However the regimen of choice is not yet defined. Methods The primary objective of this comparative, open, randomised multicentre trial is to compare two chemotherapy regimens (cisplatin/docetaxel versus cisplatin/gemcitabine) in the management of resected NSCLC with quality of life (GoL) evaluated at the end of treatment as the primary objective. The secondary objectives are to study the impact of these two chemotherapy regimens on overall and relapse free survival, haematological and non-haematological toxicities, and costs. The primary judgement criterion will be the assessment of end of treatment GoL by the standardised questionnaire, EORTC QLQ-C30. Secondary judgement criteria will be Qol measured by EORTC QLQ-LC13 and SF36, overall and relapse free survival, tolerance and costs. The number of subjects needed is 75 in each group, 150 in total, to detect a difference of 10 points on the EORTC QLC-C30 scores with a standard error of 20 points (alpha 0.05; power 80%). Expected results This trial will provide clinicians with data on the impact of two currently unexplored adjuvant chemotherapy regimens on quality of life, tolerance and costs in NSCLC.