Clinical trial NCT02555592: Strategy of Surgical Resection With Adjuvant Therapy for IIIA NSCLC and N2 Disease Only in Subaortic or Paraaortic Level
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Cancer of Lymph Node
Effects of Chemotherapy
Surgery
Lead sponsor: Pusan National University Hospital
Sponsor class: OTHER
First posted: 2015-09-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Three-year disease free survival
timeFrame: Three year
Secondary outcomes:
measure: Three-year survival rate
timeFrame: Three year
measure: Five-year survival rate
timeFrame: Five year
measure: Recurrence rate
timeFrame: Five year
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
Study officials:
affiliation: Pusan National University Hospital
name: Jung Seop Eom, Master
role: PRINCIPAL_INVESTIGATOR
References:
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