To Evaluate Postoperative 3D Conform Radiotherapy in Patients With IIIA (N2) Non-small Cell Lung Cancer
Several important international randomized trials have shown that postoperative chemotherapy contributed to the improvement on 5 year survival rate by about 4% for patients with non-small cell lung cancer after complete resection. But the overall survival rate was relatively low and the local recurrence was still the dominant failure pattern for stage IIIA (N2) disease even these patients received the postoperative chemotherapy. Several meta-analyses have shown that postoperative radiotherapy has no effect on the survival improvement for patients with non-small lung cancer after complete resection. However, sub-group analysis based on the same dataset of these meta-analyses showed that the postoperative radiotherapy with conventional radiotherapy might be beneficial for stage IIIA (N2) disease. The 3D conform radiotherapy can increase the radiation dose to the target volume while decreasing the dose to risk organs comparing with the conventional radiotherapy. So it is expected that postoperative 3D conform radiotherapy after postoperative chemotherapy will improve the local control and overall survival rate for stage IIIA (N2) non-small cell lung cancer. Here, the investigators designed a phase III randomized trial to compare the three years overall and disease free survival rate in patients with completely resected stage IIIA (N2) non-small cell lung cancer who receive the chemotherapy alone or the chemotherapy plus 3D conform radiotherapy.
Non-small Cell Lung Cancer
Radiation: 3D conform radiotherapy
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
- Toxicity of thoracic radiotherapy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|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.
|Contact: Guangfei Ou, PhD, MDemail@example.com|
|Cancer Insititute and Hosiptal of Chinese Academy of Medical Sciences||Recruiting|
|Beijing, China, 100021|
|Contact: Guangfei Ou, PhD, MD 8610-87788503 firstname.lastname@example.org|
|Principal Investigator: Luhua Wang, MD|
|Principal Investigator:||Luhua Wang, MD||Cancer Instititute and Hosiptal of Chinese Academy of Medical Sciences|