Strategy of Surgical Resection With Adjuvant Therapy for IIIA NSCLC and N2 Disease Only in Subaortic or Paraaortic Level

NCT02555592 | Unknown

• 1 other identifier: 56 study
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to identify the treatment outcomes of surgical resection with sequential adjuvant chemotherapy and radiotherapy in patients with stage IIIA non-small cell lung cancer and N2 disease at only the sub- or para-aortic level.

Conditions

Lung Cancer; Cancer of Lymph Node; Effects of Chemotherapy; Surgery

Outcome Measures

Primary Outcomes (1)

• Three-year disease free survival

  Three year

Secondary Outcomes (3)

• Three-year survival rate

  Three year

• Five-year survival rate

  Five year

• Recurrence rate

  Five year

Interventions

Primary surgical resection with sequential adjuvant therapy PROCEDURE

First, surgery resection of the affected lung with mediastinal lymph node dissection, including sub- and para-aortic lymph node, will be performed. If malignant tumor involvement only in the sub- or para-aortic lymph nodes is identified, adjuvant chemotherapy will be initiated within 8 weeks after surgery. After completion of adjuvant chemotherapy, post-operative radiotherapy will be initiated within 2\~4 weeks after adjuvant chemotherapy.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with stage IIIA non-small cell lung cancer and N2 disease only in the subaortic or paraaortic level, or both

You may qualify if:

• Patients with stage IIIA non-small cell lung cancer and suspicious of N2 disease only in the subaortic or paraaortic level, or both on chest CT or PET scan

You may not qualify if:

• Patients whose subaortic or paraaortic lymph nodes were revealed as negative by mediastinal lymph node dissection
• Patients whose mediastinal lymph nodes other than subaortic or paraaortic level were confirmed as malignant node by mediastinal lymph node dissection

Sponsors & Collaborators

• Pusan National University Hospital: lead

Study Sites (1)

Pusan National University Hospital

Busan, Busan, 602-739, South Korea

RECRUITING

Related Publications (8)

• Silvestri GA, Gonzalez AV, Jantz MA, Margolis ML, Gould MK, Tanoue LT, Harris LJ, Detterbeck FC. Methods for staging non-small cell lung cancer: Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013 May;143(5 Suppl):e211S-e250S. doi: 10.1378/chest.12-2355.

  PMID: 23649440 BACKGROUND

• Vansteenkiste J, De Ruysscher D, Eberhardt WE, Lim E, Senan S, Felip E, Peters S; ESMO Guidelines Working Group. Early and locally advanced non-small-cell lung cancer (NSCLC): ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2013 Oct;24 Suppl 6:vi89-98. doi: 10.1093/annonc/mdt241. Epub 2013 Jul 16. No abstract available.

  PMID: 23860613 BACKGROUND

• De Leyn P, Dooms C, Kuzdzal J, Lardinois D, Passlick B, Rami-Porta R, Turna A, Van Schil P, Venuta F, Waller D, Weder W, Zielinski M. Revised ESTS guidelines for preoperative mediastinal lymph node staging for non-small-cell lung cancer. Eur J Cardiothorac Surg. 2014 May;45(5):787-98. doi: 10.1093/ejcts/ezu028. Epub 2014 Feb 26.

  PMID: 24578407 BACKGROUND

• Cerfolio RJ, Bryant AS, Eloubeidi MA. Accessing the aortopulmonary window (#5) and the paraaortic (#6) lymph nodes in patients with non-small cell lung cancer. Ann Thorac Surg. 2007 Sep;84(3):940-5. doi: 10.1016/j.athoracsur.2007.04.078.

  PMID: 17720403 BACKGROUND

• Miller DL, McManus KG, Allen MS, Ilstrup DM, Deschamps C, Trastek VF, Daly RC, Pairolero PC. Results of surgical resection in patients with N2 non-small cell lung cancer. Ann Thorac Surg. 1994 May;57(5):1095-100; discussion 1100-1. doi: 10.1016/0003-4975(94)91335-8.

  PMID: 8179370 BACKGROUND

• Nakanishi R, Osaki T, Nakanishi K, Yoshino I, Yoshimatsu T, Watanabe H, Nakata H, Yasumoto K. Treatment strategy for patients with surgically discovered N2 stage IIIA non-small cell lung cancer. Ann Thorac Surg. 1997 Aug;64(2):342-8. doi: 10.1016/S0003-4975(97)00535-3.

  PMID: 9262572 BACKGROUND

• Okada M, Tsubota N, Yoshimura M, Miyamoto Y, Matsuoka H. Prognosis of completely resected pN2 non-small cell lung carcinomas: What is the significant node that affects survival? J Thorac Cardiovasc Surg. 1999 Aug;118(2):270-5. doi: 10.1016/S0022-5223(99)70217-5.

  PMID: 10425000 BACKGROUND

• Keller SM, Vangel MG, Wagner H, Schiller JH, Herskovic A, Komaki R, Marks RS, Perry MC, Livingston RB, Johnson DH; Eastern Cooperative Oncology Group. Prolonged survival in patients with resected non-small cell lung cancer and single-level N2 disease. J Thorac Cardiovasc Surg. 2004 Jul;128(1):130-7. doi: 10.1016/j.jtcvs.2003.11.061.

  PMID: 15224032 BACKGROUND

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jung Seop Eom, Master

  Pusan National University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jung Seop Eom, Master

CONTACT

82-10-2081-0859; ejspulm@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical assistant professor

Study Record Dates

• First Submitted: September 17, 2015
• First Posted: September 21, 2015
• Study Start: October 1, 2015
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 6, 2015

Record last verified: 2015-10

Locations

KR (1)