Concomitant chemoradiotherapy for treatment of non-small cell lung cancer - the Conrad study

INTERVENTION: The participants will be randomised to the following two arms: Arm 1: Chemotherapy and thoracic radiation Arm 2: Chemotherapy alone Chemotherapy: All patients will receive 4 cycles of identical regimes of chemotherapy: Oral vinorelbine tablets 60 mg/m^2 orally (per os) day 1 and 8 and intravenous carboplatin AUC = 5 (Calvert's formula) over one hour day 1. However, the doses will be adjusted according to age (patients age greater than 75 year will be given 75% of full dose from cure no.1) and haematological toxicity. Schedule of radiation therapy: Simulator planned, two opposing fields with fractionation 2.8 Gy x 15. The radiotherapy should start at the same time as or just after cycle number two. Cycle number three should be given three weeks after cycle number two. CONDITION: Non‐small cell lung cancer ; Cancer ; Malignant neoplasm of bronchus and lung PRIMARY OUTCOME: Overall survival, followed‐up for 52 weeks. SECONDARY OUTCOME: 1. Health related quality of life, assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer patients (EORTC QLQ‐C30) version 3.0 and the lung cancer specific module EORTC QLQ‐LC13. The questionnaires will be sent to the patients every month during the treatment period and every second month after the treatment period for a total of 10 questionnaires completed per patient. ; 2. Time to progression, followed‐up for 52 weeks; 3. In field relapse, followed‐up for 52 weeks; 4. Drug related adverse event frequency and severity, followed‐up for 52 weeks; 5. Health economics, followed‐up for 52 weeks INCLUSION CRITERIA: 1. Chemo‐naive patients with non‐small cell lung cancer (NSCLC) locally advanced stage III, not candidates for radical radiotherapy and with no pleural effusion 2. Performance status (World Health Organization [WHO]) 0 ‐ 2 3. Ability to understand oral and written study information 4. Both males and females, no age limit 5. S‐creatinine less than 1.5 times upper reference limit, bilirubin and S‐transaminase levels less than 2 times upper limits. Normal white blood‐cell and platelet count.