Clinical trial · Interventional
Evaluation of Efficacy of Minimally Invasive Local Therapy for Lung Tumors and Its Impact on Breathing Function
Investigation of the Efficacy of Local Minimally Invasive Ablative Therapy for Pulmonary Tumors and Its Impact on Respiratory Function
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer (Non-Small Cell) | Malignant Lung Neoplasm | CURATED_EXACT | 0.85 |
| Lung Metastases From Any Primary | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ablation | Procedure | — | UNRESOLVED |
| SBRT | Radiation | — | UNRESOLVED |
| Surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Surgery
- description
- Surgical treatment with the aim of complete tumor removal with safety margins. The procedures may include lobectomies, segmentectomies, atypical resections, or pneumonectomies. The surgery may or may not include regional lymph node dissection.
- interventionNames
- Procedure: Surgery
- type
- ACTIVE_COMPARATOR
- label
- SBRT
- description
- Stereotactic body radiation therapy (SBRT) will be performed with the aim of radical tumor eradication by delivering very high doses of radiation to the tumor. Dose and fractionation regimens will be individualized, with a target median BED₁₀ of 100 Gy.
- interventionNames
- Radiation: SBRT
- type
- ACTIVE_COMPARATOR
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available