A Trial to Evaluate the Improvement in Lung Cancer Patients Receiving Radiation With or Without Brachytherapy

A Phase III, Multi-centre, Randomized Trial to Evaluate the Symptomatic and Quality of Life Improvements in Lung Cancer Patients Receiving External Beam Radiation With or Without High Dose Rate Intraluminal Brachytherapy

A trial to improve the quality of life of patients with advanced non-small cell lung cancer (NSCLC) by evaluating the symptomatic improvements in lung cancer patients receiving external radiation with or without high dose internal radiation.

In patients with advanced NSCLC to compare the added benefit of High Dose Rate Intraluminal Brachytherapy (HDRIB) with External Beam Radiation (EBR). Benefit will be assessed by measuring the proportion of patients who achieve symptomatic improvement in lung cancer symptoms.

Inclusion Criteria:

• Cytologic or histologic proof of non-small cell lung cancer (NSCLC)
• Stages III, IV or recurrent disease
• Documented endobronchial luminal disease by either endoscopy or CT-imaging
• Candidate for palliative thoracic radiation therapy because of cough, shortness of breath or hemoptysis

Exclusion Criteria:

• Age less than 18 years of age
• Uncontrolled or symptomatic brain metastases
• Anticipated survival of less than 3 months
• Systemic therapy planned to begin within 6 weeks following randomization
• Systemic therapy within 4 weeks of planned study randomization
• Any prior radiotherapy involving the lungs
• Cardiac arrest or myocardial infarction within 6 months prior to study randomization
• Inability to receive sedation or undergo invasive procedures due to severe chronic obstructive pulmonary disease (COPD), bleeding disorders, or other medical conditions which will preclude the use of HDRIB
• Pregnancy, lactation, or failure to use dual-method contraception in pre-menopausal women
• Unwillingness or inability (e.g. incompetence, severe psychiatric disorders) to complete informed consent and the baseline QoL assessments required for the trial
• Having received an investigational agent within one month of study randomization
• Inability to attend regular follow-up evaluations due to psychiatric or addictive disorder or geographic inaccessibility