Outcomes of Surgical Resection After Induction Treatment in Non-Small Cell Lung Cancer (SRaIT)

Study Overview
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Brief Summary
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Surgery still remains the main treatment option for Non-Small Cell Lung Cancer (NSCLC) which is limited within the lung parenchyma and possibly invades the intrapulmonary or hilar nodes. The role of surgery in locally advanced NSCLC with the form of invasion of adjacent strictures or mediastinal nodes is a 30-year point of discussion and debate among thoracic surgeons, clinical and radiation oncologists, chest physicians and other related specialties. Despite the continuous debate the management of locally advanced NSCLC varies between different countries and different institutions.We try to investigate the short and long term outcomes of surgery after induction treatment performed for locally advanced NSCLC.

Detailed Description
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All patients who underwent surgery with curative intent or salvage after induction treatment during a 8-year time period (2011-2019). Induction treatment with the form either of chemotherapy or chemoradiotherapy was delivered according to the thoracic multidisciplinary team decision which it was based on primary tumor histology and stage. Patients with Pancoast tumors were excluded from the study design, because these tumors have different clinical characteristics and represent a separate category of NSCLC with a well recognized specific treatment plan worldwide. Overall 42 patients are included in the study and the recorded parameters in each patient are: Age, gender, comorbidities, histology, location in the lung and stage of tumor at presentation, tools used for preoperative staging in each case, any previous surgical procedures of other treatments performed before elsewhere, type of induction treatment, tools used for tumor restaging. In each patient were recorded any specific technical details concerning the applied surgical procedures, time of surgery and one-lung ventilation (OLV), postoperative complications and their management, mortality, pos-resection staging (ypTNM), the number of resected lymph nodes in each patient. Concerning the long term outcomes, overall and disease-free survival, kind of recurrence (local, distant, combination) and treatment of recurrences were recorded. Interpretation fo the results will include the correlation of surgical details, kind and dose of induction treatment with postoperative complications, especially infectious complications and prolonged air leaks. Radicality of the resection and response of the tumor to induction treatment (ypTNM stage) as it is recorded in histology reports are the two important clinical parameters to be studied for their effect on long term survival and recurrences. Surgery was applied as salvage surgery in not well responded tumors or as resection of downstaged tumors.

Official Title
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Short and Long Term Outcomes of Patients With Locally Advanced Non-Small Cell Lung Cancer Undergoing Pulmonary Parenchyma Resection After Induction Treatment.

Conditions
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Patient Outcome Assessment, Morbidity, Mortality

Intervention / Treatment
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* Procedure: Pulmonary parenchyma resection, lobectomy, pneumonectomy, sleeve lobectomy, extended lobectomy/pneumonectomy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who underwent surgery for NSCLC after induction treatment Exclusion Criteria: Patients who underwent surgery fo NSCLC located in the superior sulcus and Pancoast syndrome.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Pulmonary parenchyma resection, lobectomy, pneumonectomy, sleeve lobectomy, extended lobectomy/pneumonectomy|Resection of the downstaged locally advanced NSCLC through formal thoracotomy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality-Morbidity | Mortality and morbidity of the pulmonary parenchyma resection for NSCLC after induction treatment | From date of surgery until 12 weeks after surgery | 
| Long term survival of patients and correlation of long term survival with the post-resection stage of tumor (ypTNM stage) | Close clinical follow-up by clinical oncologists and surgeons to detect and treat | From the date of surgery to up to 96 months after surgery | 
| Recurrence of tumor - Disease free survival | Close clinical follow-up by clinical oncologists and surgeons to detect and treat recurrences. Correlation of recurrences with post-resection (ypTNM) stage of tumor, completeness of resection, type of surgical procedure | From date of surgery to up to 96 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Specific details concerning the surgical procedures and correlation with morbidity | Extended procedures, intrapericardial procedures, pneumonectomy | From time of surgery to up to 12 weeks after surgery | 
| Respiratory complications | Correlation of the overall time required for the procedure and of the time of one lung ventilation with the rate and kind of respiratory complications and ICU stay | From time of surgery to up to 12 weeks after surgery | 
| Postoperative complications | Correlation of kind and overall dose of the delivered chemotherapy or radiotherapy with the development of postoperative complications, especially prolonged air leak and infectious complications | From time of surgery to up to 12 weeks after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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NSCLC, Locally Advanced NSCLC, Induction treatment, Induction chemotherapy, Induction chemoradiotherapy, Pulmonary Parenchyma Resection, Surgical Outcomes, Survival, Morbidity, Thoracotomy