Evaluation of Efficacy of Minimally Invasive Local Therapy for Lung Tumors and Its Impact on Brea… (NCT07272356) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Evaluation of Efficacy of Minimally Invasive Local Therapy for Lung Tumors and Its Impact on Breathing Function
Lithuania68 participantsStarted 2022-11-22
Plain-language summary
This clinical study is evaluating different treatment options for patients with malignant lung tumors, including both primary lung cancer and tumors that have spread to the lungs from other parts of the body. The goal is to compare the safety, effectiveness, and quality-of-life impact of three approaches: surgery, stereotactic body radiotherapy (SBRT), and minimally invasive thermal ablation (microwave or cryoablation).
Thermal ablation is a procedure in which a small antenna is inserted through the skin into the tumor and the cancer cells are destroyed using heat or freezing. SBRT uses precisely targeted radiation to destroy tumors, while surgery involves removing part of the lung. These methods are already used in routine care, but this study directly compares them to understand which patients may benefit most from each approach.
In addition to cancer control, the study is measuring how these treatments affect breathing function. Patients will have regular follow-up visits with CT scans, breathing tests, and blood draws for up to two years.
About 100 adults in Lithuania are expected to participate. The results will help doctors make better treatment recommendations, balancing cancer control with patient well-being, lung function, and quality of life.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults (18 years or older)
* Verified systemic therapy-naive biopsy-proven NSCLC, stages from Tis to T2; or oligometastatic peripheral (≤ 5 lesions) lung disease;
* All lesions are ≤3 cm in size and accessible for surgery, ablation or SBRT;
* No local nodal or distant metastatic disease on diagnostic imaging;
* Documented agreement on the recommended curative treatment by a multidisciplinary team, including a pulmonologist, interventional radiologist, radiation therapist, thoracic surgeon, and oncologist;
* Documented patient's agreement to receive the intended therapy and to participate in this study via a signed informed consent form.
Exclusion Criteria:
* Central lung tumors (\<2 cm from the main bronchi or hilum);
* \>5 or diffuse lung lesions, or prior local treatment to the same lesion;
* Major comorbidities, physical or social limitations precluding trial participation;
* Contraindications to general anesthesia, inability to temporarily withdraw antiplatelet therapy, or evidence of severe coagulopathy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.