Radical Resection With Contralateral Lymph Node Dissection for Clinical N3 NSCLC

NCT07003490 | Recruiting DMC

• 1 other identifier: 2025HS068
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 2

Brief 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.

• 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

Keywords

NSCLC; Lung cancer; Lymph node dissection; Radical resection; Surgery; N3 stage; Stage IIIB; Contralateral lymph node metastasis

Outcome Measures

Primary Outcomes (1)

• Evaluation of the Efficacy of Primary Tumor Resection Combined with Bilateral Lymph Node Dissection in Non-Small Cell Lung Cancer Patients with Contralateral Thoracic Lymph Node Metastasis

  The clinical efficacy of the surgery in contralateral lymph node metastasis patients will be assessed by analyzing postoperative disease-free survival (DFS).

  12 months for disease-free survival

Secondary Outcomes (8)

• Evaluation of intra-operative blood loss

  Perioperative

• Evaluation of post-operative pain

  Perioperative

• Evaluation of incidence of post-operative complications

  Perioperative

• Evaluation of chest tube retention time

  Perioperative

• Evaluation of chest tube drainage output

  Perioperative

Study Arms (1)

Surgical treatment group

EXPERIMENTAL

Patients in this arm are diagnosed with clinical N3 stage lung cancer which specifically involves contralateral lymph node metastasis by PET scan. And these patients will be treated with radical resection with bilateral lymph node dissection.

Procedure: Radical Resection with Bilateral Lymph Node Dissection

Interventions

Radical Resection with Bilateral Lymph Node Dissection PROCEDURE

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.

Surgical treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed primary non-small cell lung cancer (NSCLC): The diagnosis must be confirmed through pathological examination, and the patient must meet one of the following histological types: adenocarcinoma, squamous cell carcinoma, or large cell carcinoma.
• PET-CT indicating contralateral mediastinal lymph node metastasis, N3 stage: Patients must have lung cancer classified as stage N3 based on positron emission tomography (PET) scans, with evidence of contralateral mediastinal lymph node involvement.
• Age range: Patients must be aged between 18 and 75 years.
• Good cardiopulmonary function:Preoperative evaluation must show no significant cardiovascular conditions (e.g., heart failure, severe coronary artery disease) or severe respiratory diseases (e.g., chronic obstructive pulmonary disease), and the patient must have good heart function (LVEF ≥ 45%), with the ability to tolerate surgery.Preoperative pulmonary function assessment must meet the surgical criteria, with forced expiratory volume in 1 second (FEV1) ≥ 50% of predicted value.
• Resectable tumor: Based on imaging studies (such as CT or MRI) and assessment by thoracic surgeons, the patient must be deemed suitable for surgical resection and planned for primary tumor resection combined with bilateral lymph node dissection.
• No distant metastasis: Full-body imaging (such as CT or PET-CT) must show no evidence of distant metastasis, indicating that the patient is suitable for localized treatment.
• ECOG performance status of 0-1: Patients must have an ECOG performance status score of 0-1 (as per Attachment 1), indicating that they are clinically in good physical condition and able to perform daily activities independently.
• Informed consent: The patient and their family members must voluntarily sign an informed consent form after being fully informed of the purpose, content, risks, and potential benefits of the study, consenting to participate in the research.

You may not qualify if:

• Patients with unresectable tumors: This includes patients with tumors extensively invading vital organs (e.g., major blood vessels, spine, heart) or those for whom complete surgical resection is not feasible.
• Patients with severe comorbidities: These include individuals with severe cardiovascular diseases (e.g., heart failure, history of myocardial infarction, arrhythmia), severe respiratory diseases (e.g., chronic obstructive pulmonary disease, severe asthma), or other uncontrolled systemic diseases that may affect the patient's ability to tolerate surgery safely.
• Patients with distant metastasis: This includes patients with imaging findings suggestive of metastasis to distant organs, such as the liver, bones, or brain.
• Patients with allergies to anesthetic agents or contraindications to anesthesia: This includes patients with a history of severe allergies or those with significant pulmonary or cardiovascular comorbidities that increase the anesthesia risk.
• Pregnant or lactating women: Due to potential risks associated with radiological examinations (e.g., PET scans) and surgery for the fetus or infant.
• Patients with psychiatric disorders or those unable to comprehend the informed consent form: This includes patients who are unable to provide independent informed consent or fully understand the study protocol and associated risks.
• Patients unable to comply with follow-up requirements: This includes patients who are unable to attend scheduled postoperative follow-up visits, such as those living far from the hospital or with other logistical barriers.
• Patients with concurrent malignant hematologic diseases or other primary cancers: This includes patients who have other primary malignancies, especially those with high recurrence risks, in addition to lung cancer.
• Patients with known immune deficiencies or immune system disorders: This includes patients with severe immunodeficiency diseases, HIV, a history of organ transplantation, or other conditions that may compromise postoperative recovery and affect the efficacy of antitumor treatments.
• Elderly patients unable to tolerate surgery or anesthesia: This includes elderly individuals with multiple chronic conditions or functional decline, making them unable to tolerate surgical risks.
• Patients with severe hepatic or renal dysfunction: This includes patients with liver cirrhosis, renal failure, or other severe organ dysfunction that may prevent them from tolerating surgery and postoperative treatments.
• Patients with active infections: This includes patients with active infectious diseases, such as pneumonia being treated with antibiotics, especially those with contagious conditions such as tuberculosis or bacterial pneumonia.
• Patients with severe diabetes: This includes patients with unstable blood sugar control and diabetes-related complications (e.g., diabetic retinopathy, diabetic foot) that may complicate postoperative recovery.
• Patients currently participating in other clinical trials: This includes patients enrolled in other clinical studies whose treatments may interfere with the interventions in this study.
• Patients with severe malnutrition: This includes patients with significant weight loss or malnutrition that may impair postoperative recovery and increase anesthesia risk.

Sponsors & Collaborators

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

Study Sites (2)

Shanghai General Hospital Thoracic Surgery Department

Shanghai, Shanghai Municipality, 200080, China

NOT YET RECRUITING

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, 200080, China

RECRUITING

Related Publications (5)

• Watanabe Y, Shimizu J, Oda M, Hayashi Y, Tatsuzawa Y, Watanabe S, Urayama H, Iwa T. Results of surgical treatment in patients with stage IIIB non-small-cell lung cancer. Thorac Cardiovasc Surg. 1991 Feb;39(1):50-4. doi: 10.1055/s-2007-1013930.

  PMID: 1849325 BACKGROUND

• Beck SL. Prenatal and postnatal assessment of Maneb-exposed CD-1 mice. Reprod Toxicol. 1990;4(4):283-90. doi: 10.1016/0890-6238(90)90040-3.

  PMID: 2136049 BACKGROUND

• Bott MJ, Patel AP, Crabtree TD, Morgensztern D, Robinson CG, Colditz GA, Waqar S, Kreisel D, Krupnicka AS, Patterson GA, Broderick S, Meyers BF, Puri V. Role for Surgical Resection in the Multidisciplinary Treatment of Stage IIIB Non-Small Cell Lung Cancer. Ann Thorac Surg. 2015 Jun;99(6):1921-8. doi: 10.1016/j.athoracsur.2015.02.033. Epub 2015 Apr 23.

  PMID: 25912748 BACKGROUND

• Tian Z, Zhang J, Liu D, Liang C. Lobectomy with Lymph Node Dissection Benefits N3 Stage Non-Small Cell Lung Cancer Patients: A Population-Based Study. Oncology. 2025;103(6):445-455. doi: 10.1159/000541634. Epub 2024 Sep 30.

  PMID: 39348811 BACKGROUND

• Riquet M, Mordant P, Fabre-Guillevin E, Arame A, Foucault C, Dujon A, Le Pimpec Barthes F. Long-term survival with surgery as part of a multimodality approach for N3 lung cancer. Eur J Cardiothorac Surg. 2013 Dec;44(6):1117-22. doi: 10.1093/ejcts/ezt171. Epub 2013 Mar 29.

  PMID: 23543202 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Lung Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Wu

CONTACT

086-17721217378; wuliang1982@aliyun.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Chief Physician

Model Details: single center, single arm, interventional study

Study Record Dates

• First Submitted: April 18, 2025
• First Posted: June 4, 2025
• Study Start: January 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: June 19, 2025

Record last verified: 2025-06

Locations

CN (2)