Clinical trial · Observational
Mediastinal Staging Accuracy of a Selective Lymphadenectomy Strategy in Early Stage NSCLC (ECTOP-1003)
Evaluation of the Mediastinal Staging Accuracy of a Selective Lymphadenectomy Strategy Based on Tumor Location, Ground Glass Opacity Component and Frozen Section Diagnosis in Peripheral cT1N0M0 Invasive Non-small Cell Lung Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymph Node Metastases | — | UNRESOLVED | — |
| Non-small Cell Lung Cancer Stage I | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intra-operative frozen section | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- The assumed selective lymph node dissection group
- description
- 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.
- interventionNames
- Diagnostic Test: Intra-operative frozen section
Primary outcomes (1)
- measure
- Mediastinal staging accuracy of the assumed selective lymph node dissection strategy
- timeFrame
- 2-3 weeks after the surgery until the final pathology results are reported.
- description
- To compare the mediastinal staging results by the assumed selective lymph node dissection strategy and the final staging results by systematic lymph node dissection.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * Previous malignancy or lung surgery * Previous induction therapy for the disease * Intolerable to the surgery * Incomplete mediastinal lymph node dissection or lymph node sampling
References
Publications (0)
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