NCT00864331

Optimization of Treatment of Advanced Nonsmall Cell Lung Cancer Using Radiotherapy and Chemotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 251 (actual)
• Sponsor: International Atomic Energy Agency · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Non Small Cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	radiation	39 Gy in 13 daily fractions of 3 Gy
OTHER	Chemotherapy and radiotherapy	Chemotherapy followed by low dose palliative radiotherapy
DRUG	Chemotherapy	Chemotherapy given alone
OTHER	Palliative radiotherapy and chemotherapy	Low dose palliative radiotherapy followed by chemotherapy

Timeline

• Start date: 2008-02-01
• Primary completion: 2012-11-01
• Completion: 2012-11-01
• First posted: 2009-03-18
• Last updated: 2013-08-07

Locations

13 sites across 13 countries: Chile, China, Croatia, Egypt, India, Malaysia, Malta, Morocco, Pakistan, Panama, Peru, South Africa, Tunisia