Radical Resection With Contralateral Lymph Node Dissection for Clinical N3 NSCLC

Summary

\*Study Overview This study is investigating a surgical approach for patients with a serious type of lung cancer known as non-small cell lung cancer (NSCLC), particularly those in an advanced stage where cancer has spread to both sides of the chest (referred to as N3 stage). In these patients, the cancer has spread to contralateral lymph nodes, which are lymph nodes located on the opposite side of the chest. This spread makes the cancer harder to treat and lowers the chance of survival.

The study is focusing on whether removing the primary lung tumor along with lymph nodes from both sides of the chest-a surgery called bilateral lymph node dissection-can improve the chances of survival and reduce the risk of cancer returning.

\*Why This Study Is Important Stage N3 NSCLC (where cancer has spread to both sides of the chest) is hard to treat and has a poor prognosis. Current treatments include surgery, chemotherapy, and radiation, but the long-term survival rates are still low.

This study will evaluate whether surgery alone (with the tumor and lymph nodes removed) can improve survival in these patients compared to other treatment options.

The goal is to find the best way to treat patients with N3 stage NSCLC by studying the risks and benefits of this combined surgical approach.

* What the Study Is Testing

1. Effectiveness of surgery for N3 stage patients: Does removing both the primary tumor and lymph nodes from both sides of the chest improve survival rates?
2. Safety of the surgery: What are the risks or complications from such an extensive operation? For example, the study will check for things like infections, lung function problems, and other side effects.
3. Impact of other treatments: The study will also look at whether treatments like chemotherapy or radiation before surgery (called neoadjuvant therapy) change the results of surgery.
4. Impact of lymph node involvement: The study will examine how many lymph nodes are affected by cancer and how this affects treatment outcomes.
* Who Can Participate? The study is looking for people diagnosed with N3 stage NSCLC, meaning their cancer has spread to lymph nodes on both sides of the chest. Patients must be considered eligible for surgery based on their overall health and the specific characteristics of their cancer.
* What Will the Patients Experience? Patients who take part in this study will undergo surgery to remove their lung tumor and lymph nodes from both sides of the chest.

They will receive follow-up care to monitor for any complications, such as infections, and to see if the cancer comes back.

Patients will be monitored for several years to track their survival, recurrence of cancer, and any long-term effects of the surgery.

\*What Could This Mean for Patients? If the study shows that this combined surgery approach is effective, it could become a standard treatment for patients with N3 stage NSCLC, improving their chances of survival and possibly reducing the need for more aggressive treatments like chemotherapy or radiation in the future.

However, it's important to note that surgery of this type comes with risks, and not all patients will be suitable candidates for this approach. The study aims to better understand these risks and benefits to help doctors make the best treatment decisions for each individual patient.

\*Key Takeaways for Healthcare Providers The study is investigating radical surgery for N3 stage NSCLC, with an emphasis on bilateral lymph node dissection to improve survival.

The study will assess surgical outcomes, complications, and long-term survival rates in patients with metastasis to lymph nodes on both sides of the chest.

Findings may lead to a new approach in treating patients with N3 stage lung cancer, offering potential improvements in patient outcomes.

Conditions

• NSCLC, Non Small Cell Lung Cancer

Interventions

PROCEDURE

Radical Resection with Bilateral Lymph Node Dissection

The patient will be positioned in a contralateral decubitus position based on the location of the primary tumor, with the axillary region on the side of the primary tumor exposed. For example, if the patient is diagnosed with left-sided primary lung cancer with right-sided lymph node metastasis, investigators perform left axillary incision to resect the tumor. And then investigators change the patient's position to perform right axillary incision to resect the lymph nodes. Thoracoscopy surgery will be used to access and resect the primary lesion and lymph node metastasis.

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-01-01

Primary Completion

2027-05-01

Completion

2027-08-01

Countries

• China

Study Locations