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

NCT07272356 | Active Not Recruiting

• 1 other identifier: 2022-BE-10-0015
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Cancer (Non-Small Cell); Lung Metastases From Any Primary

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

Outcome Measures

Primary Outcomes (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.

  Up to 24 months after treatment.

Secondary Outcomes (8)

• Disease Recurrence

  Up to 24 months after treatment.

• Survival

  Up to 24 months after treatment

• Complication Rates

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

• Hospitalization

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

• Respiratory Function: spirometry

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

Study Arms (3)

Surgery

ACTIVE COMPARATOR

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.

Procedure: Surgery

SBRT

ACTIVE COMPARATOR

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.

Radiation: SBRT

Ablation

ACTIVE COMPARATOR

Image-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.

Procedure: Ablation

Interventions

Surgery PROCEDURE

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.

Also known as: Lobectomy, Anatomical resection, Atypical resection, Segmentenctomy

Surgery

Ablation PROCEDURE

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.

Also known as: Microwave ablation, Cryoablation

Ablation

SBRT RADIATION

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.

Also known as: Stereotactic body radiotherapy, Radiotherapy

SBRT

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aurimas Macionis: lead

Study Sites (1)

Lithuanian University of Health Sciences Kaunas Clinics

Kaunas, 50161, Lithuania

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Respiratory Aspiration

Interventions

Surgical Procedures, Operative; Anterior Temporal Lobectomy; Cryosurgery; Radiosurgery; Radiotherapy

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurosurgical Procedures; Ablation Techniques; Therapeutics; Stereotaxic Techniques; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2025
• First Posted: December 9, 2025
• Study Start: November 22, 2022
• Primary Completion (Estimated): June 14, 2026
• Study Completion (Estimated): June 14, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Available starting 12 months after publication, and accessible for 3 years.
• Access Criteria: Researchers with a methodologically sound proposal; requests to be submitted to Kaunas Regional Biomedical Research Ethics Committee: Lithuanian University of Health Sciences, Mickevičiaus g. 9, LT-44307, Kaunas Phone: +370 37 326889 Email: kaunorbtek@lsmuni.lt

Locations

LI (1)