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

  • STATUS
    Recruiting
  • End date
    Dec 21, 2021
  • participants needed
    25
  • sponsor
    Pusan National University Hospital
Updated on 21 January 2021
cancer
lung cancer
adjuvant therapy
adjuvant chemotherapy
immunomodulators
stage iiia non-small cell lung cancer
ct scan chest
lung carcinoma

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.

Details
Condition Pulmonary Disease, Surgery, Surgical aspects, Lung Neoplasm, Surgery, Bronchial Neoplasm, Effects of Chemotherapy, Cancer of Lymph Node, Lung Cancer, Lung Disease, carcinoma lung, lung carcinoma, surgical procedures, surgical treatment, surgeries, surgical procedure
Treatment Primary surgical resection with sequential adjuvant therapy
Clinical Study IdentifierNCT02555592
SponsorPusan National University Hospital
Last Modified on21 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Gender: Male or Female
Do you have any of these conditions: Lung Neoplasm or Bronchial Neoplasm or Surgery or Surgical aspects or Effects of Chemotherapy or Cancer of Lymph Node?
Do you have any of these conditions: Lung Neoplasm or Cancer of Lymph Node or surgeries or Lung Disease or Effects of Chemotherapy or Pulmonary Disease or Bronchial Neoplasm or Lung Cance...?
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
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