Clinical trial · Observational

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

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

NCT04092465CI-TRIAL-00040642SRaITcompletedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Morbidity	—	UNRESOLVED	—
Mortality	—	UNRESOLVED	—
Patient Outcome Assessment	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Pulmonary parenchyma resection, lobectomy, pneumonectomy, sleeve lobectomy, extended lobectomy/pneumonectomy	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (0)

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Primary outcomes (3)

measure
Mortality-Morbidity
timeFrame
From date of surgery until 12 weeks after surgery
description
Mortality and morbidity of the pulmonary parenchyma resection for NSCLC after induction treatment
measure
Long term survival of patients and correlation of long term survival with the post-resection stage of tumor (ypTNM stage)
timeFrame
From the date of surgery to up to 96 months after surgery
description
Close clinical follow-up by clinical oncologists and surgeons to detect and treat
measure
Recurrence of tumor - Disease free survival
timeFrame
From date of surgery to up to 96 months after surgery
description
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

Eligibility

Eligibility (as posted)

Sex: All

Show eligibility criteria text

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.

References

Publications (5)

BACKGROUNDShepherd 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
BACKGROUNDRusch 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
BACKGROUNDAlbain 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
BACKGROUNDSonett 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
BACKGROUNDKumar 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