RecruitingPhase 2NCT04375904

'SOURCE - LUNG' Stereotactic Ablative Radiation Therapy Of UltRaCEntral LUNG Tumours (SOURCE Lung)

'SOURCE - LUNG' Stereotactic Ablative Radiation Therapy Of UltRaCEntral LUNG Tumours


Sponsor

Cancer Trials Ireland

Enrollment

68 participants

Start Date

Dec 22, 2020

Study Type

INTERVENTIONAL

Conditions

Summary

This is a phase II, non-randomised study examining the safety of treating high risk centrally located non-small cell lung cancer (NSCLC) tumours and single pulmonary oligometastatic lesions using radiation therapy (RT), for patients whose disease is inoperable. The method of delivering the RT in this study is image guided stereotactic ablative radiation therapy (IG-SABR). This method involves using imaging to ensure the radiation is being delivered to the correct location within the body and using higher than normal doses per treatment (fraction) to treat the lung cancer (NSCLC)/oligometastatic lung lesion. This study aims to determine its safety by looking at the number and severity of side effects. This study will deliver 8 treatments/fractions of RT with 7.5 Gy delivered in each fraction. To be eligible for this study the initial treatment plan for the patient must be shown to not fulfil certain criteria relating to doses to the tumour and surrounding normal tissue. This study has its own study specific criteria which must be adhered to. Translational sub-studies (optional) are open to patients in participating centres only. Patients will have the option to consent to participating in both translational studies or to neither.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests a specialized type of radiation therapy called stereotactic ablative radiotherapy (SABR) — a highly precise, high-dose radiation delivered in a few sessions — for tumors located in a challenging central area of the lung near major airways and blood vessels. It aims to find the safest effective dose for these difficult-to-treat tumors. **You may be eligible if...** - You are 18 or older - You have a confirmed primary lung cancer (non-small cell) or a single cancer spread (metastasis) to the lung that needs local treatment - Your tumor is located in the central lung area and meets specific radiation planning criteria - You cannot have surgery, or you declined surgery - You are in generally good health (ECOG performance status 0-2) with a life expectancy over 6 months **You may NOT be eligible if...** - Your tumor is directly touching your esophagus - You have evidence of spread to lymph nodes or other organs (for primary lung cancer) - You have conditions that make you more sensitive to radiation (e.g., certain hereditary syndromes or pulmonary fibrosis) - You received chemotherapy or targeted therapy within 3 months before planned radiotherapy - You previously had radiation to the chest or middle chest area - You cannot lie still for a 4D CT scan 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

RADIATIONImage-Guided Stereotactic Ablative Radiotherapy (IG-SABR)

Image-Guided Stereotactic Ablative Radiotherapy (IG-SABR) delivered in 8 fractions of 7.5 Gy. OAR constraints must be respected but a minimum dose coverage to 95% of the PTV will be allowed down to 75% and a minimum dose to 99% of the GTV allowed at 75%. Respiratory monitoring/active respiratory management will be used. Plans will be created and delivered using photon beams with energies between 6-10 MV.


Locations(2)

Beacon Hospital

Dublin, Ireland

St Luke's Radiation Oncology Network (SLRON) at St Luke's Hospital and St James's Hospital

Dublin, Ireland

View Full Details on ClinicalTrials.gov

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

Visit

NCT04375904