To Evaluate Postoperative 3D Conform Radiotherapy in Patients With IIIA (N2) Non-small Cell Lung Cancer
Recruitment status was: Recruiting
|Thoracic Neoplasms Non-small Cell Lung Cancer||Radiation: 3D conform radiotherapy||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Phase III Comparison of Postoperative 3D Conform Radiotherapy After Chemotherapy and Chemotherapy Alone in Patients With Completely Resected Stage IIIA(N2) Non-small Cell Lung Cancer|
- Overall survival rate [ Time Frame: 3 years ]
- Toxicity of thoracic radiotherapy [ Time Frame: 6 months ]
|Study Start Date:||January 2009|
|Estimated Study Completion Date:||July 2012|
|Estimated Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Radiation: 3D conform radiotherapy
3D conform radiotherapy, 2 Gy per fraction, total 25 fractions (50Gy).
Other Name: Radiation
|No Intervention: 2|
Primary: To determine whether administering chemotherapy (four cycles of NP regimen) plus 3D conform thoracic radiotherapy (50 Gy, 2 Gy once daily over 5 weeks) will improve 3-year survival compared with chemotherapy (four cycles of NP regimen) alone in patients with completely resected stage IIIA (N2) non-small cell lung cancer.
Secondary: To compare treatment-related toxic effects, failure-free survival, and the patterns of failure.
OUTLINE: This is a multicenter, randomized study. Patients are stratified according to histology (squamous cell vs other), number of mediastinum lymph nodes, and whether N2 disease has been diagnosed before operation.
Arm I: Patients undergo 3D conform thoracic radiotherapy (50 Gy, 2 Gy once daily over 5 weeks) after postoperative chemotherapy of four cycles of NP regimen.
Arm II: Patients undergo postoperative chemotherapy of four cycles of NP regimen.
After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00880971
|Contact: Guangfei Ou, PhD, MDfirstname.lastname@example.org|
|Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences||Recruiting|
|Beijing, China, 100021|
|Contact: Guangfei Ou, PhD, MD 8610-87788503 email@example.com|
|Principal Investigator: Luhua Wang, MD|
|Principal Investigator:||Luhua Wang, MD||Cancer Instititute and Hosiptal of Chinese Academy of Medical Sciences|