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The objective of this multicenter retrospective study is to compare overall survival in patients with stage IIIA-N2 NSCLC treated with neoadjuvant treatment and surgery versus definitive chemoradiation.
Secondary objectives are to analyze disease-free survival, median survival, locoregional and distant relapses as well as mortality and toxicity related to treatment.
Based on data published by the Intergroup 0139 trial, induction therapy followed by surgery in patients with stage IIIA-N2 NSCLC can increase overall survival compared to exclusive radical chemoradiation treatment.
The major handicap of all studies addressing the role of surgery in IIIA-N2 NSCLC is the difficulty of recruiting patients. Therefore, multicenter studies are necessary to confirm the hypothesis generated by the INT 0139.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chemoradiation Group | Analyze overall survival in the group of patients treatment by Concurrent Radiotherapy (>/= 60 Gy) plus Platinum-based Chemotherapy |
| |
| Neoadjuvant treatment plus Surgery Group | Analyze overall survival in the group of patients treatment by Neoadjuvant Platinum-based Chemotherapy or Chemoradiation (Platinum-based plus >/= 45Gy) followed by Surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Overall survival | Other | Compare overall survival between both groups. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-free survival | 5 years | |
| Patterns of Relapse | 5 years | |
| Mortality |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with stage IIIA-N2 NSCLC potentially resectable at diagnosis.
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| Name | Affiliation | Role |
|---|---|---|
| Felipe Couñago, MD PhD | Grupo de Investigación Clínica en Oncología Radioterapia | Principal Investigator |
| Sara Montemuiño, MDPhd | Grupo de Investigación Clínica en Oncología Radioterapia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario Quiron Madrid | Madrid | 28290 | Spain |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| 5 years |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |