Actively Recruiting

Phase Not Applicable
Age: 18Years - 75Years
All Genders
NCT07003490

Radical Resection With Contralateral Lymph Node Dissection for Clinical N3 NSCLC

Led by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Updated on 2025-06-19

30

Participants Needed

2

Research Sites

134 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

\*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

Official Title

Radical Resection With Contralateral Lymph Node Dissection for Clinical N3 NSCLC

Who Can Participate

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed primary non-small cell lung cancer (adenocarcinoma, squamous cell carcinoma, or large cell carcinoma)
  • PET-CT showing contralateral mediastinal lymph node metastasis (N3 stage)
  • Age between 18 and 75 years
  • Good cardiopulmonary function: heart function with LVEF 25 45%, and FEV1 25 50% of predicted value
  • Tumor suitable for surgical resection with planned primary tumor and bilateral lymph node dissection
  • No distant metastasis found on full-body imaging
  • ECOG performance status of 0-1 indicating good physical condition
  • Voluntary informed consent signed by patient and family
Not Eligible

You will not qualify if you...

  • Tumors that cannot be fully removed by surgery, including those invading vital organs
  • Severe cardiovascular or respiratory diseases affecting surgical safety
  • Presence of distant metastases to organs like liver, bones, or brain
  • Allergies or contraindications to anesthesia
  • Pregnant or breastfeeding women
  • Psychiatric disorders or inability to understand informed consent
  • Inability to comply with follow-up visits
  • Other primary cancers or malignant blood diseases
  • Known immune deficiencies or history of organ transplantation
  • Elderly patients unable to tolerate surgery or anesthesia
  • Severe liver or kidney dysfunction
  • Active infections including contagious diseases like tuberculosis
  • Severe diabetes with complications
  • Participation in other clinical trials
  • Severe malnutrition
  • Severe blood disorders such as anemia or thrombocytopenia
  • Severe chronic respiratory failure requiring ventilator or tracheostomy

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Shanghai General Hospital Thoracic Surgery Department

Shanghai, Shanghai Municipality, China, 200080

Not Yet Recruiting

2

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China, 200080

Actively Recruiting

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Research Team

W

Wu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Radical Resection With Contralateral Lymph Node Dissection for Clinical N3 NSCLC | DecenTrialz