Primary objectives of the study are: To assess the differences in survival of the two treatment options in both stage III (A and B) nonsmall cell lung cancer (NSCLC) (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study B), respectively Secondary objectives are: To assess the differences in toxicity of two treatment options in both stage III (A and B) NSCLC (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study B), and To assess the differences in Health Related Quality of Life (HRQoL) of two treatment options in both Study A and Study B
To compare survival rates (median and 1-year), and toxicity of two treatment regimens in patients with locally advanced incurable NSCLC (study A), to compare survival rates (median and 1-year) of two treatment regimens in patients with locally advanced and metastatic NSCLC (study B) To compare HRQoL and cost effectiveness of two treatment regimens in patients with locally advanced incurable NSCLC (study A), and in patients with locally advanced and metastatic NSCLC (study B) and to evaluate the effect of HRQoL assessment on QoL dimensions
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
251
39 Gy in 13 daily fractions of 3 Gy
Chemotherapy followed by low dose palliative radiotherapy
Chemotherapy given alone
Low dose palliative radiotherapy followed by chemotherapy
Instituto de Radiomedicine
Santiago, Chile
Affiliated Hospital of Ning Xia Medical College, Department of Radiation Oncology
Yinchuan, China
University of Zagreb Faculty of Medicine
Zagreb, Croatia
Misr Oncology Center (MOC)
Cairo, Egypt
Tata Memorial Centre (TMC) Department of Atomic Energy (DAE)
Mumbai, India
General Hospital Kuala Lumpur, Institute of Radiotherapy and Oncology
Kuala Lumpur, Malaysia
Sir Paul Boffa Hospital
Floriana, Malta
Ministère de la Santé, Institut National d'Oncologie Sidi Mohamed Ben Abdellah
Rabat, Morocco
Nuclear Medicine Oncology and Radiotherapy Institute
Islamabad, Pakistan
Instituto Oncológico National
Panama City, Panama
...and 3 more locations
Survival
Time frame: 1 year
To assess the differences in toxicity of two treatment options in both stage III (A and B) NSCLC (Study A) and Stage IIIB (wet) and stage IV NSCLC (Study B)
Time frame: 1 year
To assess the differences in Health Related Quality of Life (HRQoL) of two treatment options in both Study A and Study B
Time frame: 1 year
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