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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
134
EBR of 20 Gy in 5 daily fractions over one week plus HDRIB of 14 Gy in 2 fractions over two weeks
EBR of 20 Gy in 5 daily fractions over one week
Abbotsford Centre - BC Cancer Agency
Abbotsford, British Columbia, Canada
Juravinski Cancer Centre
Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Kingston, Ontario, Canada
Grand River Regional Cancer Centre
Kitchener, Ontario, Canada
For each subject, a lung cancer-related symptomatic improvement at 6 weeks post randomization, defined as a 10-point improvement on a 100 point scale from the summary question of lung cancer symptoms
Time frame: 6 weeks from randomization
Improvement in each lung cancer symptom as measured by the Lung Cancer Symptom Scale (LCSS) as defined by a 10-point improvement for cough, shortness of breath, hemoptysis and pain on the LCSS at 6 weeks post randomization
Time frame: 6 weeks post randomization
Improvement in each lung cancer symptom and overall symptoms at any time after randomization
Time frame: at 3, 6, 12, 18, 26, 34, 42 and 50 weeks post-randomization
A Quality of Life (QOL) improvement as measured be overall score of the LCSS, at each scheduled assessment point following randomization (Weeks 3, 6, 12, 26, 34, 42 and 50)
Time frame: Weeks 3, 6, 12, 18, 26, 34, 42 and 50
Symptomatic progression-free survival (SPFS), defined as the time from randomization until death, use of chemotherapy, or the first post-randomization score on LCSS #7 which is 10 points or greater than the baseline score, or scored at 100.
Time frame: From date of randomization until the date of first documented use of chemotherapy, or progression whichever came first, assessed up to 48 months
Overall survival, calculated from the date of randomization to the date of death
Time frame: From date of randomization until the date of death from any cause assessed up to 48 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
London Regional Cancer Centre
London, Ontario, Canada
UHN-Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Windsor Regional Hospital Cancer Centre
Windsor, Ontario, Canada
CHUQ - L'Hôtel-Dieu de Québec
Québec, Quebec, Canada