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

September 14, 2019 updated by: Christophoros N. Foroulis, AHEPA University Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

42

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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)
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
From the date of surgery to up to 96 months after surgery
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
From date of surgery to up to 96 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From time of surgery to up to 12 weeks after surgery
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
From time of surgery to up to 12 weeks after surgery
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
From time of surgery to up to 12 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AHEPA University Hospital

Investigators

  • Principal Investigator: CHRISTOFOROS N FOROULIS, Professor, Ahepa University Hospital
  • Principal Investigator: KYRIAKOS ANASTASIADIS, Professor, Ahepa University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 30, 2011

Primary Completion (Actual)

August 31, 2019

Study Completion (Actual)

August 31, 2019

Study Registration Dates

First Submitted

August 31, 2019

First Submitted That Met QC Criteria

September 14, 2019

First Posted (Actual)

September 17, 2019

Study Record Updates

Last Update Posted (Actual)

September 17, 2019

Last Update Submitted That Met QC Criteria

September 14, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 425/12-9-2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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