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

NCT ID: NCT04092465

Last Updated: 2019-09-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2019-08-31

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.

Conditions

Patient Outcome Assessment; Morbidity; Mortality

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

Resection of the downstaged locally advanced NSCLC through formal thoracotomy

Intervention Type: PROCEDURE

Other Intervention Names

induction chemotherapy, induction chemoradiotherapy

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AHEPA University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Christophoros N. Foroulis

Associate Professor of Thoracic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

CHRISTOFOROS N FOROULIS, Professor

Role: PRINCIPAL_INVESTIGATOR

AHEPA University Hospital

KYRIAKOS ANASTASIADIS, Professor

Role: PRINCIPAL_INVESTIGATOR

AHEPA University Hospital

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 8380477 (View on PubMed)

Albain KS, Rusch VW, Crowley JJ, Rice TW, Turrisi AT 3rd, Weick JK, Lonchyna VA, Presant CA, McKenna RJ, Gandara DR, et al. Concurrent cisplatin/etoposide plus chest radiotherapy followed by surgery for stages IIIA (N2) and IIIB non-small-cell lung cancer: mature results of Southwest Oncology Group phase II study 8805. J Clin Oncol. 1995 Aug;13(8):1880-92. doi: 10.1200/JCO.1995.13.8.1880.

Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 15464470 (View on PubMed)

Kumar P, Herndon J 2nd, Langer M, Kohman LJ, Elias AD, Kass FC, Eaton WL, Seagren SL, Green MR, Sugarbaker DJ. Patterns of disease failure after trimodality therapy of nonsmall cell lung carcinoma pathologic stage IIIA (N2). Analysis of Cancer and Leukemia Group B Protocol 8935. Cancer. 1996 Jun 1;77(11):2393-9. doi: 10.1002/(SICI)1097-0142(19960601)77:113.0.CO;2-Q.

Reference Type: BACKGROUND

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Other Identifiers

425/12-9-2019

Identifier Type: -

Identifier Source: org_study_id