RecruitingNot ApplicableNCT06634979

Selective Lymph Node Resection for Invasive Non-small Cell Lung Cancer With the CTR of 0.5-1 and the Diameter of ≤ 2 cm

Selective Lymph Node Resection for Invasive Non-small Cell Lung Cancer With the CTR of 0.5-1 and the Diameter of ≤ 2 cm: a Prospective, Single-arm, Multi-center, Phase Ⅱ Trial


Sponsor

Fudan University

Enrollment

684 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The study investigated the efficacy and safety of a selective lymph node strategy (no lower mediastinal lymph node dissection for upper lobe tumors and no upper mediastinal lymph node dissection for lower lobe tumors) in patients with 0.5 \< CTR \< 1 and ≤ 2 cm in diameter cT1N0M0 infiltrating NSCLC, aiming to more accurately assess the prognosis of the selective lymph node dissection strategy for nodes with 0.5 \< CTR \< 1 and ≤ 2 cm in diameter.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how much of the lymph node tissue around a small early-stage lung cancer needs to be removed during surgery. It tests whether surgeons can remove fewer lymph nodes (selective resection) without compromising cancer outcomes, for a specific type of small mixed-density lung tumor. This could mean less trauma and faster recovery for patients. **You may be eligible if...** - You are between 18 and 80 years old - You have non-small cell lung cancer confirmed by pathology - Your tumor is 2 cm or smaller, with a solid-to-total ratio between 0.5 and 1 on CT scan - You have not had prior lung cancer surgery or treatment - The cancer appears to be in an early stage (T1N0M0 — no lymph nodes or distant spread) - Your overall physical function is good (ECOG 0–1) **You may NOT be eligible if...** - Your tumor does not meet the size or density criteria - The cancer cannot be completely surgically removed - The cancer is a type other than non-small cell lung cancer - You have had prior lung cancer surgery or treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESelective lymph node dissection

For 0.5 \< CTR \< 1 and ≤ 2 cm diameter cT1N0M0 invasive non-small cell lung cancer patient sex for selective lymph node (lower mediastinal lymph nodes are not required to be cleared for upper lobe tumors and upper mediastinal lymph nodes are not required to be cleared for lower lobe tumors)


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, China

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NCT06634979


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