An observational study in Patient Outcome Assessment, Morbidity and Mortality, sponsored by AHEPA University Hospital. Completed. Per ClinicalTrials.gov, last updated 2019-09-17.
Sponsored by AHEPA University Hospital · Observational
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.
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:
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.
6,488 studies on the registry are indexed under Carcinoma, Non-Small-Cell Lung; 1,632 are open to participants now.
This study's enrollment of 42 is below the median of 161 across 949 observational studies indexed under Carcinoma, Non-Small-Cell Lung.
Browse Carcinoma, Non-Small-Cell Lung studies →AHEPA University Hospital is the lead sponsor of 34 studies on the registry; 4 are open to participants now.
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All patients who underwent resection with curative intent of their locally advanced NSCLC after induction treatment in a single Academic Center from September 2011 to August 2019 (8 years). Surgery was applied either in downstaged tumors os as salvage extended surgery in patients not responding to induction treatment.
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.
Resection of the downstaged locally advanced NSCLC through formal thoracotomy
Also known as: induction chemotherapy, induction chemoradiotherapy
Mortality-Morbidity
Mortality and morbidity of the pulmonary parenchyma resection for NSCLC after induction treatment
Time frame: 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
Time frame: 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
Time frame: From date of surgery to up to 96 months after surgery
Specific details concerning the surgical procedures and correlation with morbidity
Extended procedures, intrapericardial procedures, pneumonectomy
Time frame: 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
Time frame: 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
Time frame: From time of surgery to up to 12 weeks after surgery
No study locations are listed for this record.
Plan to share: No
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Carcinoma, Non-Small-Cell Lung→
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