RecruitingNot ApplicableNCT05354596

A Multicenter Phase II Study of Stereotactic Radiotherapy for Centrally Located Lung Tumors (STRICT-LUNG STUDY) and Ultra-centrally Located Lung Tumors (STAR-LUNG STUDY).

Stereotactic Radiation Therapy In Centrally Located Lung and Ultra-centrally Located Tumors in the Lung. STRICT-LUNG & STAR-LUNG STUDY


Sponsor

Rigshospitalet, Denmark

Enrollment

138 participants

Start Date

Nov 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

An open-label phase II study, investigating toxicity, treatment efficacy and the local tumor control rate in 69 patients with centrally located tumors and in 69 patients with ultra-centrally located tumors in the lung. Treatment and patient outcomes will be recorded. Centrally located tumors are treated on standard-linacs with daily CBCT image-guidance and plan adaptation. Ultra-centrally tumors are treated on MR-linacs with daily MR-guided plan-adaptation.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing focused, high-precision radiation therapy (stereotactic body radiotherapy, or SBRT) for lung tumors located near critical structures like the airway, esophagus, heart, or spinal cord — places where standard SBRT is considered more risky. The study includes two groups: "central" tumors (near major airways) and "ultra-central" tumors (directly touching the main airway). **You may be eligible if...** - You are over 18 years old with biopsy-proven or clinically evident non-blood cancer with local progression - Your tumor is 5 cm or smaller and is located near or touching central airway or critical structures - You are unable to have surgery or have refused it - You have a life expectancy greater than 6 months - All other cancer sites are treated or planned for treatment **You may NOT be eligible if...** - Your tumor is growing inside the airway or trachea - You have uncontrolled illness - You are pregnant - You are already participating in another interventional trial - For ultra-central tumors: you have a pacemaker or MRI-incompatible metal implants Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDURESTRICT LUNG

Stereotactic body radiation therapy: Centrally located tumors are treated on standard-linacs with daily CBCT image-guidance and plan adaptation.

PROCEDURESTAR LUNG

Stereotactic body radiation therapy: Ultra-centrally tumors are treated on MR-linacs with daily MR-guided plan-adaptation.


Locations(6)

Aalborg University Hospital

Aalborg, Denmark

Aarhus University Hospital

Aarhus, Denmark

Rigshospitalet

Copenhagen, Denmark

Herlev University Hospital

Herlev, Denmark

Odense University Hospital

Odense, Denmark

Department of Oncology, Lillebaelt Hospital

Vejle, Denmark

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT05354596


Related Trials