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

NCT07272356 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-12-09

No results posted yet for this study

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

Interventions

PROCEDURE

Surgery

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.

PROCEDURE

Ablation

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.

RADIATION

SBRT

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.

Sponsors & Collaborators

  • Aurimas Macionis

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-22
Primary Completion
2026-06-14
Completion
2026-06-14

Countries

  • Lithuania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07272356 on ClinicalTrials.gov