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Lung Cancer (Non-Small Cell)NCT07272356

Evaluation of Efficacy of Minimally Invasive Local Therapy for Lung Tumors and Its Impact on Breathing Function

A study testing Surgery, Ablation and SBRT in people with Lung Cancer (Non-Small Cell) and Lung Metastases From Any Primary, run by Aurimas Macionis at 1 site in Lithuania.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Surgery, Ablation and SBRT
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
68 participants
Where
1 siteLithuania
Study dates
22 Nov 2022to 14 Jun 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Lithuania1 site
  • Lithuanian University of Health Sciences Kaunas Clinics

    Kaunas, 50161

Other trials in Lithuania

About this study

Official title: Investigation of the Efficacy of Local Minimally Invasive Ablative Therapy for Pulmonary Tumors and Its Impact on Respiratory Function

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.

Read more

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.

Read the detailed description

Lung cancer remains one of the leading causes of cancer-related death worldwide, and the lungs are also a common site of metastases from other cancers such as colorectal, breast, or kidney tumors. While surgery is considered the gold standard for treatment of early-stage lung cancer and resectable pulmonary metastases, many patients are not suitable surgical candidates due to age, comorbidities, or personal choice. For these patients, less invasive treatments such as stereotactic body radiotherapy (SBRT) or image-guided thermal ablation may provide effective alternatives.

This study is designed to evaluate the safety, effectiveness, and patient-centered outcomes of three treatment strategies for malignant lung tumors:

  • Surgery (anatomical lung resection, when feasible)
  • Stereotactic body radiotherapy (SBRT), which delivers high doses of precisely targeted radiation
  • Minimally invasive thermal ablation, performed under CT guidance using microwave or cryoablation technology to destroy tumor tissue with heat or freezing

Thermal ablation and SBRT are established treatment options in many centers worldwide, but there is limited prospective data directly comparing these modalities with surgery. This trial aims to address that gap by examining not only oncologic outcomes such as recurrence, survival, and complications, but also functional and quality-of-life outcomes.

Study Objectives:

  • To compare disease control (local, regional, and distant recurrence) and survival outcomes across surgery, SBRT, and ablation.
  • To evaluate complication rates and hospitalization needs after each treatment.
  • To assess the effect of each treatment on respiratory function using spirometry, gas diffusion testing, and lung perfusion scintigraphy.
  • To monitor health-related quality of life (HRQoL) using the SF-36 questionnaire before and after treatment.

Study Design:

This is a prospective, single-center, non-randomized study conducted at the Lithuanian University of Health Sciences Kaunas Clinics. Eligible patients are adults (≥18 years) with either primary peripheral lung cancer or oligometastatic pulmonary disease (≤5 lesions, each ≤3 cm in size), who are suitable for surgery, SBRT, or thermal ablation based on multidisciplinary team (MDT) assessment. Patients are assigned to one of the three treatment groups-surgery, SBRT, or ablation-based on clinical suitability and shared decision-making between the MDT and the patient.

Follow-Up Procedures:

Participants are followed for up to 24 months with scheduled visits and investigations, including:

  • Clinical assessments at baseline, 1, 3, 6, 12, 18, and 24 months
  • Chest CT scans at baseline and 1, 3, 6, 12, 18, and 24 months after the treatment
  • FDG-PET/CT if clinically indicated
  • Spirometry and gas diffusion testing at baseline, 3 months, and 6 months
  • Lung perfusion scintigraphy at baseline and 3 months
  • Blood sampling (up to 10 ml) at baseline, 3 months, and 6 months
  • Completion of quality-of-life questionnaires at baseline and one month after treatment

Risks and Benefits:

Risks include discomfort from diagnostic procedures (blood draws, imaging, spirometry), possible treatment-related complications such as pneumothorax after ablation, infection or post-operative pain after surgery, and radiation-related side effects (e.g., radiation pneumonitis, infection) after SBRT. However, all procedures are well-established in clinical practice, and serious complications are rare. Benefits include close monitoring of disease status with imaging, which may enable early detection of recurrence and timely treatment. Patients may also benefit from comprehensive functional assessments that can guide future care.

Expected Outcomes:

This study is expected to provide comparative information on the safety, effectiveness, and impact on quality of life of surgery, stereotactic body radiotherapy, and minimally invasive thermal ablation in patients with malignant lung tumors. By evaluating recurrence, survival, complications, and respiratory function, the study aims to identify which patients benefit most from each treatment approach and to support more personalized treatment planning in the future.

Sample Size and Duration:

The study aims to enroll approximately 100 participants in Lithuania. Each participant will be followed for two years after treatment.

Significance:

This study is expected to provide valuable evidence on the comparative effectiveness of surgery, SBRT, and thermal ablation in the management of malignant pulmonary tumors. By integrating oncologic, functional, and quality-of-life outcomes, the study seeks to support personalized medicine approaches and improve decision-making in multidisciplinary care of lung cancer and metastases.

Being tested
Surgery, Ablation, SBRT
Keywords
non-small cell lung cancer, lung metastases, image-guided thermal ablation, surgery, microwave ablation, cryoablation, stereotactic body radiotherapy, cancer recurrence, quality-of-life, oncologic control, respiratory function
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SurgeryProcedure or surgery

    Also called Lobectomy, Anatomical resection, Atypical resection, Segmentenctomy

    Surgical resection performed under general anaesthesia, including lobectomy, segmentectomy, or atypical resection. All anatomical resections were accompanied by lymph node dissection, while atypical resections were performed without lymph node removal. Procedures were carried out via open thoracotomy, with some performed through mini-thoracotomy.

  • AblationProcedure or surgery

    Also called Microwave ablation, Cryoablation

    Image-guided thermal ablation performed under general anaesthesia with CT guidance, including microwave ablation (TATO2 system, single or overlapping insertions) and cryoablation (CryoCare Touch™ system, three freeze-thaw cycles). Tract sealing was performed to minimize complications.

  • SBRTRadiation

    Also called Stereotactic body radiotherapy, Radiotherapy

    Stereotactic body radiation therapy delivered with a Varian TrueBeam™ linear accelerator, using 4D-CT planning, daily cone-beam CT image guidance, RTOG-based organ-at-risk constraints, and individualized fractionation regimens with the aim of a median biologically effective dose of 100 Gy.

Study groups in NCT07272356
Study groupRoleWhat they receive
SurgeryActive comparatorSurgical 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.
Receives: Procedure: Surgery
SBRTActive comparatorStereotactic 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.
Receives: Radiation: SBRT
AblationActive comparatorImage-guided thermal ablation is a minimally invasive treatment aiming for radical tumor destruction using either heat or cold. In this trial, procedures include microwave ablation and cryoablation, all performed under general anaesthesia with CT guidance to ensure complete lesion coverage and adequate safety margins.
Receives: Procedure: Ablation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Local oncologic control

    Evaluate and compare local relapse rates on CT or PET/CT imaging following surgery, stereotactic body radiotherapy (SBRT), or thermal ablation. Local disease control is the central measure of treatment effectiveness.

    Measured: Up to 24 months after treatment.

Secondary outcomes (8)
  1. Disease Recurrence

    Evaluate and compare regional and distant recurrence rates following surgery, stereotactic body radiotherapy (SBRT), or thermal ablation.

    Measured: Up to 24 months after treatment.

  2. Survival

    Evaluate and compare disease-free survival (DFS) and overall survival (OS) following surgery, stereotactic body radiotherapy (SBRT), or thermal ablation.

    Measured: Up to 24 months after treatment

  3. Complication Rates

    Frequency, severity, and type of treatment-related complications, classified according to CIRSE (Cardiovascular and Interventional Radiological Society of Europe) standards.

    Measured: Immediately post-treatment and throughout the 24-month follow-up.

  4. Hospitalization

    Length of hospital stay required for each treatment modality.

    Measured: From the date of treatment until the date of discharge, assessed up to 24 months

  5. Respiratory Function: spirometry

    Changes in forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), and FEV1/FVC due to treatment. The values are described as absolute values (litres), percentages of predicted values, and z-scores.

    Measured: Baseline before treatment and 3-12 months post-treatment.

  6. Respiratory Function: gas diffusion

    Changes in forced expiratory volume in diffusing capacity of the lung for carbon monoxide, corrected for hemoglobin (DLCOc ) due to treatment. The values are described as mmol/min/kPa or % pred

    Measured: Baseline before treatment and 3-12 months post-treatment.

  7. Respiratory Function: lung perfusion scintigraphy

    Changes in lung lobar perfusion percentages on SPECT/CT due to treatment. Lobar perfusion percentages calculated from SPECT counts (total counts in a lobe / total counts in both lungs x 100), the data expressed in millilitres (mL).

    Measured: Baseline before treatment and 3-12 months post-treatment.

  8. Health-Related Quality of Life

    Changes in patient-reported outcomes using the 36-Item Short Form Health Survey (SF-36 questionnaire), focusing on physical, social, emotional, and mental health domains. The data of each domain is expressed in a score from 0 to 100, with 0 representing the poorest health status and 100 indicating the best possible health status.

    Measured: At baseline and one month post-treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2025
  2. Study start22 Nov 2022
  3. Primary completion14 Jun 2026 (estimated)
  4. Study completion14 Jun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07272356
Sponsor's protocol ID
2022-BE-10-0015
Status last verified
Nov 2025
First submitted
28 Sep 2025
Last updated
9 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Yes, de-identified IPD will be shared. IPD Types: Baseline demographics, tumor characteristics, treatment details, and outcome measures (local control, survival, toxicity). Supporting Documents: Study protocol, informed consent form.

Questions about this trial

What is this clinical trial studying?

A study testing Surgery, Ablation and SBRT in people with Lung Cancer (Non-Small Cell) and Lung Metastases From Any Primary, run by Aurimas Macionis at 1 site in Lithuania.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local oncologic control (time frame: Up to 24 months after treatment.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.

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