A dose escalation phase I study of continuous, hyperfractionated, accelerated radiotherapy (CHART) in patients with inoperable non-small cell lung cancer

Sheffield Teaching Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 18 人开始时间: 2009年12月3日最近更新: 2022年9月12日

适应症

试验速览

•Queries about inclusion criteria should be addressed prior to entry into the study. Patients are eligible for the study if all of the following criteria are met:
•1. Histologically or cytologically confirmed stage III NSCLC
•2. World Health Organization (WHO) performance status 0 or 1
•3. Life expectancy greater than 6 months
•4. Inoperable disease as assessed by a Lung Cancer Multi-Disciplinary Team (MDT) with input from Thoracic Surgeon; or operable but the patient refuses surgery
•5. Aged 18 or over (no upper age limit), either sex
•6. No prior thoracic radiotherapy
•7. No prior lobectomy/pneumonectomy
•8. No prior systemic chemotherapy
•9. Willing and able to give informed consent
•10. Adequate pulmonary function test (PFT) results: forced expiratory volume in one second (FEV1) and/or carbon monoxide transfer factor (DCLO) greater than or equal to 40% of predicted
•11. For women with childbearing potential:
•11.1. Negative pregnancy test
•11.2. Adequate contraceptive precautions

•Patients are ineligible for the trial if any of the following criteria are met:
•1. Previous or current malignant disease likely to interfere with the protocol treatment or comparisons
•2. Medically unstable (e.g. unstable diabetes, uncontrolled arterial hypertension, infection, hypercalcaemia, cardiovascular disease such as congestive cardiac failure)
•3. Previous diagnosis of interstitial lung disease
•4. Previous diagnosis of spinal cord disease
•5. Women of childbearing potential who are not practicing adequate contraceptive precautions
•6. Women who are pregnant or lactating
•7. Connective tissue disorders (e.g. scleroderma, systemic lupus erythematosus)

发起方

Sheffield Teaching Hospitals NHS Foundation Trust (UK)