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

Lung Cancer Clinical Trial

Official title:

Treatment Strategy of Surgical Resection With Sequential Adjuvant Chemotherapy and Radiotherapy for Patients With Stage IIIA Non-small Cell Lung Cancer and N2 Disease Only in the Subaortic or Paraaortic Level, or Both

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02555592
• Other study ID #: 56 study
• Status: Recruiting
• Phase: N/A
• First received: September 17, 2015
• Last updated: October 5, 2015
• Start date: October 2015
• Est. completion date: December 2021

Study information

• Verified date: October 2015
• Source: Pusan National University Hospital
• Contact: Jung Seop Eom, Master
• Phone: 82-10-2081-0859
• Email: ejspulm[@]gmail.com
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

Stage IIIA non-small cell lung cancer (NSCLC) is a very heterogeneous disease and current treatment guidelines recommend concurrent chemoradiation therapy or combined neoadjuvant chemotherapy, surgical resection, and sequential adjuvant therapy. When incidental N2 disease is found despite thorough preoperative staging, adjuvant platinum-based chemotherapy with or without adjuvant radiotherapy is recommended.

Although guidelines suggest preoperative mediastinal staging with endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), this method does not allow approach of the sub- or para-aortic lymph nodes. Therefore, patients with suspected stage IIIA NSCLC and N2 disease only at the sub- or para-aortic level should undergo several processes if combined neoadjuvant chemotherapy and surgical resection is planned. First, video-assisted thoracoscopic surgery (VATS) should be performed to verify whether the sub- or para-aortic lymph nodes are involved. If a frozen-section biopsy reveals no malignant tumor involvement in the sub- and para-aortic lymph nodes, the affected lung can be resected. If there is sub- or para-aortic lymph node involvement, further neoadjuvant chemotherapy is required before surgical resection and adjuvant therapy.

Studies have shown that stage IIIA NSCLC with only sub- or para-aortic lymph node involvement has better outcomes than other stage IIIA NSCLC. Moreover, the five-year survival of patients with stage IIIA NSCLC with only sub- or para-aortic lymph node involvement is similar to that with stage II NSCLC. However, those studies were retrospective with relatively small sample sizes. Therefore, we evaluated the outcomes of combined surgical resection with adjuvant chemotherapy and radiotherapy in patients with stage IIIA NSCLC and N2 disease at only the sub- or para-aortic level.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 2021
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Primary surgical resection with sequential adjuvant therapy
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.

Locations

Country	Name	City	State
Korea, Republic of	Pusan National University Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Pusan National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (8)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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-50S. doi: 10.1378/chest.12-2355. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Three-year disease free survival		Three year	No
Secondary	Three-year survival rate		Three year	No
Secondary	Five-year survival rate		Five year	No
Secondary	Recurrence rate		Five year	No