Clinical trial NCT04092465: Outcomes of Surgical Resection After Induction Treatment in Non-Small Cell Lung Cancer (SRaIT)
Official title: Short and Long Term Outcomes of Patients With Locally Advanced Non-Small Cell Lung Cancer Undergoing Pulmonary Parenchyma Resection After Induction Treatment.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Outcome Assessment
Morbidity
Mortality
Keywords: NSCLC
Locally Advanced NSCLC
Induction treatment
Induction chemotherapy
Induction chemoradiotherapy
Pulmonary Parenchyma Resection
Surgical Outcomes
Survival
Morbidity
Thoracotomy
Lead sponsor: AHEPA University Hospital
Sponsor class: OTHER
First posted: 2019-09-17
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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: 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:

1. 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.
2. 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.
3. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mortality-Morbidity
timeFrame: From date of surgery until 12 weeks after surgery
measure: Long term survival of patients and correlation of long term survival with the post-resection stage of tumor (ypTNM stage)
timeFrame: From the date of surgery to up to 96 months after surgery
measure: Recurrence of tumor - Disease free survival
timeFrame: From date of surgery to up to 96 months after surgery
Secondary outcomes:
measure: Specific details concerning the surgical procedures and correlation with morbidity
timeFrame: From time of surgery to up to 12 weeks after surgery
measure: Respiratory complications
timeFrame: From time of surgery to up to 12 weeks after surgery
measure: Postoperative complications
timeFrame: From time of surgery to up to 12 weeks after surgery
Other outcomes:
Locations:
Study officials:
affiliation: AHEPA University Hospital
name: CHRISTOFOROS N FOROULIS, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: AHEPA University Hospital
name: KYRIAKOS ANASTASIADIS, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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