Outcomes of Surgical Resection After Induction Treatment in Non-Small Cell Lung Cancer (SRaIT) (SRaIT)
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|ClinicalTrials.gov Identifier: NCT04092465|
Recruitment Status : Completed
First Posted : September 17, 2019
Last Update Posted : September 17, 2019
|Condition or disease||Intervention/treatment|
|Patient Outcome Assessment Morbidity Mortality||Procedure: Pulmonary parenchyma resection, lobectomy, pneumonectomy, sleeve lobectomy, extended lobectomy/pneumonectomy|
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.
|Study Type :||Observational|
|Actual Enrollment :||42 participants|
|Official Title:||Short and Long Term Outcomes of Patients With Locally Advanced Non-Small Cell Lung Cancer Undergoing Pulmonary Parenchyma Resection After Induction Treatment.|
|Actual Study Start Date :||September 30, 2011|
|Actual Primary Completion Date :||August 31, 2019|
|Actual Study Completion Date :||August 31, 2019|
- Procedure: Pulmonary parenchyma resection, lobectomy, pneumonectomy, sleeve lobectomy, extended lobectomy/pneumonectomy
Resection of the downstaged locally advanced NSCLC through formal thoracotomyOther Name: induction chemotherapy, induction chemoradiotherapy
- Mortality-Morbidity [ Time Frame: From date of surgery until 12 weeks after surgery ]Mortality and morbidity of the pulmonary parenchyma resection for NSCLC after induction treatment
- Long term survival of patients and correlation of long term survival with the post-resection stage of tumor (ypTNM stage) [ Time Frame: From the date of surgery to up to 96 months after surgery ]Close clinical follow-up by clinical oncologists and surgeons to detect and treat
- Recurrence of tumor - Disease free survival [ Time Frame: From date of surgery to up to 96 months after surgery ]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
- Specific details concerning the surgical procedures and correlation with morbidity [ Time Frame: From time of surgery to up to 12 weeks after surgery ]Extended procedures, intrapericardial procedures, pneumonectomy
- Respiratory complications [ Time Frame: From time of surgery to up to 12 weeks after surgery ]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
- Postoperative complications [ Time Frame: From time of surgery to up to 12 weeks after surgery ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04092465
|Principal Investigator:||CHRISTOFOROS N FOROULIS, Professor||AHEPA University Hospital|
|Principal Investigator:||KYRIAKOS ANASTASIADIS, Professor||AHEPA University Hospital|