Mediastinal Staging Accuracy of a Selective Lymphadenectomy Strategy in Early Stage NSCLC (ECTOP-1003)

NCT03216551 | Completed

• 1 other identifier: SASLND
• Study Type: observational
• Target: 1,076
• Locations: 1 country
• Sites: 1

Brief Summary

This is a clinical trial from Eastern Cooperative Thoracic Oncology Project (ECTOP), numbered as ECTOP-1003. Systemic mediastinal lymphadenectomy is deemed indispensable in lung cancer surgery for accurate staging and complete resection. However, extensive lymphadenectomy in patients without nodal metastasis may not improve survival and would increase operative duration and cause damage to mediastinal structures.Therefore the precise selection of patients without mediastinal nodal metastasis is the key to avoid unnecessary lymphadenectomy.The investigator's previous retrospective study shows tumor location, ground glass opacity component and histological subtypes are important predictors of negative nodal status in specific mediastinal regions. The current prospective observational study is to further verify the mediastinal staging accuracy of this selective lymphadenectomy strategy.

Conditions

Lymph Node Metastases; Non-small Cell Lung Cancer Stage I

Keywords

selective mediastinal lymphadenectomy; minimally invasive surgery

Outcome Measures

Primary Outcomes (1)

• Mediastinal staging accuracy of the assumed selective lymph node dissection strategy

  To compare the mediastinal staging results by the assumed selective lymph node dissection strategy and the final staging results by systematic lymph node dissection.

  2-3 weeks after the surgery until the final pathology results are reported.

Secondary Outcomes (4)

• The accuracy of determining lepidic predominant adenocarcinoma, N1 nodes metastasis and viceral pleural invasion by frozen section

  2-3 weeks after the surgery until the final pathology results are reported.

• The nodal metastasis pattern of tumors in different lung segments.

  2-3 weeks after the surgery until the final pathology results are reported.

• The nodal status of tumors with various CT appearance

  2-3 weeks after the surgery until the final pathology results are reported.

• The lymph node metastasis rate of different histologic subytpes.

  2-3 weeks after the surgery until the final pathology results are reported.

Study Arms (1)

The assumed selective lymph node dissection group

Patients with consolidation tumor ratios ≤ 0.5 tumors will be considered to have negative mediastinal metastasis. Patients with intraoperative lepidic predominant adenocarcinoma diagnosis will be considered to have negative mediastinal metastasis. Patients with an apical tumor will be considered to have negative inferior mediastinal lymph node metastasis. If both N1 nodes and visceral pleural invasion are negative, patients with peripheral non-apical-segment upper lobe tumors will be considered to have negative inferior medistinal lymph node metastasis. If N1 nodes are negative, patients with left superior segment tumors will be considered to have negative 4L lymph node metasis, and patients with left basal segment tumors will be considered to have negative superior mediastinal lymph node metastasis.

Diagnostic Test: Intra-operative frozen section

Interventions

Intra-operative frozen section DIAGNOSTIC_TEST

Tumor histologic subtypes (whether it is lepidic predominant adenocarcinoma), N1 nodes metastasis (lymph nodes adjacent to the tumor will be sent to frozen section) and visceral pleural invasion will be determined by the intra-operative frozen section.

The assumed selective lymph node dissection group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with peripheral clinical stage T1N0M0 who intended to be treated by radical surgery.

You may qualify if:

• Informed consent must be signed
• Peripheral clinical stage T1N0M0
• Invasive non-small cell lung cancer as determined preoperatively or intraoperatively, excluding AIS/MIA
• Can be completely resected
• If there are multiple nodules, except the predominant nodule, other nodules should be pure GGO

You may not qualify if:

• Previous malignancy or lung surgery
• Previous induction therapy for the disease
• Intolerable to the surgery
• Incomplete mediastinal lymph node dissection or lymph node sampling

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

MeSH Terms

Conditions

Lymphatic Metastasis; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Haiquan Chen, MD,PhD

  Fudan University

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: July 10, 2017
• First Posted: July 13, 2017
• Study Start: March 14, 2019
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: July 20, 2023

Record last verified: 2023-07

Locations

CN (1)