BridgeMD
New treatment option for NSCLC, Non Small Cell Lung Cancer
Official title Radical Resection With Contralateral Lymph Node Dissection for Clinical N3 NSCLC
ClinicalTrials.gov ID: NCT07003490
What this study is testing
- What it's testing
- \ 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Histologically confirmed primary non-small cell lung cancer (NSCLC): The diagnosis must be confirmed through pathological examination, and the...
- PET-CT indicating contralateral mediastinal lymph node metastasis, N3 stage: Patients must have lung cancer classified as stage N3 based on positron...
- 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...
- Resectable tumor: Based on imaging studies (such as CT or MRI) and assessment by thoracic surgeons, the patient must be deemed suitable for surgical...
You likely can't join if
- Patients with unresectable tumors: This includes patients with tumors extensively invading vital organs (e.g., major blood vessels, spine, heart) or...
- Patients with severe comorbidities: These include individuals with severe cardiovascular diseases (e.g., heart failure, history of myocardial...
- Patients with distant metastasis: This includes patients with imaging findings suggestive of metastasis to distant organs, such as the liver, bones...
- Patients with allergies to anesthetic agents or contraindications to anesthesia: This includes patients with a history of severe allergies or those...
- 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...
See the full eligibility criteria
Who can join
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
- Patients with severe hematological disorders: This includes patients with conditions such as anemia or thrombocytopenia, which could complicate hemostasis during surgery and postoperative recovery.
- Patients with severe chronic respiratory failure: This includes patients who are long-term ventilator-dependent or require tracheostomy, as they may have a higher surgical risk and compromised postoperative recovery.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.