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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
Sponsor:
Information provided by (Responsible Party):
Christophoros N. Foroulis, AHEPA University Hospital

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.

Condition or disease Intervention/treatment
Patient Outcome Assessment Morbidity Mortality Procedure: Pulmonary parenchyma resection, lobectomy, pneumonectomy, sleeve lobectomy, extended lobectomy/pneumonectomy

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.

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Study Type : Observational
Actual Enrollment : 42 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Pulmonary parenchyma resection, lobectomy, pneumonectomy, sleeve lobectomy, extended lobectomy/pneumonectomy
    Resection of the downstaged locally advanced NSCLC through formal thoracotomy
    Other Name: induction chemotherapy, induction chemoradiotherapy


Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.


Information from the National Library of Medicine

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


Sponsors and Collaborators
AHEPA University Hospital
Investigators
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Principal Investigator: CHRISTOFOROS N FOROULIS, Professor AHEPA University Hospital
Principal Investigator: KYRIAKOS ANASTASIADIS, Professor AHEPA University Hospital

Publications:
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Responsible Party: Christophoros N. Foroulis, Associate Professor of Thoracic Surgery, AHEPA University Hospital
ClinicalTrials.gov Identifier: NCT04092465    
Other Study ID Numbers: 425/12-9-2019
First Posted: September 17, 2019    Key Record Dates
Last Update Posted: September 17, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Christophoros N. Foroulis, AHEPA University Hospital:
NSCLC
Locally Advanced NSCLC
Induction treatment
Induction chemotherapy
Induction chemoradiotherapy
Pulmonary Parenchyma Resection
Surgical Outcomes
Survival
Morbidity
Thoracotomy
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases