OPTIMISE Lung SABR

Sponsor
Cancer Trials Ireland
Study ID
NCT07777614
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Five fraction Image-guided Stereotactic Ablative Radiotherapy (IG-SABR) treatment — RADIATION
    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).
  • Investigational three fraction image-guided Stereotactic Ablative Radiotherapy (IG-SABR) — RADIATION
    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)

Study Details

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.

Key Dates

First listed
Aug 20, 2026
Start date
Oct 31, 2026
Status verified
Aug 2026
Primary completion
Dec 31, 2029
Completion
Jun 30, 2035

Study Design

Enrollment
208 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Five fraction IG-SABR
    Five fraction image-guided Stereotactic Ablative Radiotherapy (IG-SABR)
  • Experimental: Three fraction IG-SABR
    Investigational three fraction image-guided Stereotactic Ablative Radiotherapy (IG-SABR)

Primary Outcome Measure

To assess the incidence of ≥ Grade 3 treatment-related Adverse Events (TxR)-AEs/toxicities using NCI CTCAE V5. [ Time Frame: From start of treatment to 2 years post treatment ]

Central Contacts

  • Cancer Trials Ireland RCSI House, 121 St Stephen's Green, Dublin 2
    +353 1 667 7211
    [email protected]

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