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

NCT04092465 | Completed

• 1 other identifier: 425/12-9-2019
• Study Type: observational
• Target: 42
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (3)

• Mortality-Morbidity

  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)

  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

  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 Outcomes (3)

• Specific details concerning the surgical procedures and correlation with morbidity

  From time of surgery to up to 12 weeks after surgery

• Respiratory complications

  From time of surgery to up to 12 weeks after surgery

• Postoperative complications

  From time of surgery to up to 12 weeks after surgery

Interventions

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

Resection of the downstaged locally advanced NSCLC through formal thoracotomy

Also known as: induction chemotherapy, induction chemoradiotherapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients who underwent surgery for NSCLC after induction treatment

You may not qualify if:

• Patients who underwent surgery fo NSCLC located in the superior sulcus and Pancoast syndrome.

Sponsors & Collaborators

• AHEPA University Hospital: lead

Related Publications (5)

• Shepherd FA. Induction chemotherapy for locally advanced non-small cell lung cancer. Ann Thorac Surg. 1993 Jun;55(6):1585-92. doi: 10.1016/0003-4975(93)91123-5.

  PMID: 8390231 BACKGROUND

• Rusch VW, Albain KS, Crowley JJ, Rice TW, Lonchyna V, McKenna R Jr, Livingston RB, Griffin BR, Benfield JR. Surgical resection of stage IIIA and stage IIIB non-small-cell lung cancer after concurrent induction chemoradiotherapy. A Southwest Oncology Group trial. J Thorac Cardiovasc Surg. 1993 Jan;105(1):97-104; discussion 104-6.

  PMID: 8380477 BACKGROUND

• 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.

  PMID: 7636530 BACKGROUND

• Sonett JR, Suntharalingam M, Edelman MJ, Patel AB, Gamliel Z, Doyle A, Hausner P, Krasna M. Pulmonary resection after curative intent radiotherapy (>59 Gy) and concurrent chemotherapy in non-small-cell lung cancer. Ann Thorac Surg. 2004 Oct;78(4):1200-5; discussion 1206. doi: 10.1016/j.athoracsur.2004.04.085.

  PMID: 15464470 BACKGROUND

• 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.

  PMID: 8635112 BACKGROUND

MeSH Terms

Interventions

Pneumonectomy; Induction Chemotherapy

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures; Drug Therapy; Therapeutics; Remission Induction

Study Officials

• CHRISTOFOROS N FOROULIS, Professor

  AHEPA University Hospital

  PRINCIPAL INVESTIGATOR

• KYRIAKOS ANASTASIADIS, Professor

  AHEPA University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Thoracic Surgery

Study Record Dates

• First Submitted: August 31, 2019
• First Posted: September 17, 2019
• Study Start: September 30, 2011
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: September 17, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share