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NOT YET RECRUITING
NCT07777614
PHASE2

OPTIMISE Lung SABR

Sponsor: Cancer Trials Ireland

View on ClinicalTrials.gov

Summary

This study is a phase II multi-centre, randomised study independently evaluating five fraction Image-Guided Stereotactic Ablative Radiotherapy (IG-SABR) and three fraction IG-SABR for patients with a peripherally located T1-T2 and selected T3 and T4 lung tumours, or a peripherally located single pulmonary oligometastatic lesion.

Official title: OPTIMISation of pEripheral Lung Stereotactic Ablative Body Radiotherapy, a Prospective Independent Evaluation of 3 Fraction and 5 Fraction SABR Regimens (OPTIMISE Lung SABR)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

208

Start Date

2026-10

Completion Date

2035-06

Last Updated

2026-08-20

Healthy Volunteers

No

Interventions

RADIATION

Five fraction Image-guided Stereotactic Ablative Radiotherapy (IG-SABR) treatment

IG-SABR using a total of 5 fractions (12 Gy per fraction) to a total dose of 60 Gy prescribed to 95% of the Planning Target Volume (PTV).

RADIATION

Investigational three fraction image-guided Stereotactic Ablative Radiotherapy (IG-SABR)

IG-SABR using a total of 3 fractions (18 Gy per fraction) to a total dose of 54 Gy prescribed to 99% of the Gross Tumour Volume (GTV) with a minimum dose of 49.7 Gy to 95% of the Planning Tumour Volume (PTV) and 48 Gy to 99% of the PTV (i.e. 'optimised' three fraction SABR)

Locations (1)

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

Dublin, Ireland