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NCT Number: NCT04092465

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

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.

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Key information

Conditions

Patient Outcome Assessment Morbidity Mortality

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pulmonary parenchyma resection, lobectomy, pneumonectomy, sleeve lobectomy, extended lobectomy/pneumonectomy

Procedure

Resection of the downstaged locally advanced NSCLC through formal thoracotomy

Other names: induction chemotherapy, induction chemoradiotherapy

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AHEPA University Hospital

Other

Registry information

Official study title

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

Acronym: SRaIT

Important dates

Study start
2011
Primary completion
2019
Study completion
2019
First posted
Sep 17, 2019
Registry last updated
Sep 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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