To Evaluate Postoperative 3D Conform Radiotherapy in Patients With IIIA (N2) Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00880971|
Recruitment Status : Recruiting
First Posted : April 14, 2009
Last Update Posted : January 2, 2018
|Condition or disease||Intervention/treatment||Phase|
|Thoracic Neoplasms Non-small Cell Lung Cancer||Radiation: 3D conform radiotherapy||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2009|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2022|
Radiation: 3D conform radiotherapy
3D conform radiotherapy, 2 Gy per fraction, total 25 fractions (50Gy).
Other Name: Radiation
|No Intervention: 2|
- Overall survival rate [ Time Frame: 3 years ]
- Toxicity of thoracic radiotherapy [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|