The SABR Oligo-ACC Trial is a randomized phase II study comparing early initiation of SBRT to all metastases versus active surveillance in patients with oligometastatic ACC.
By directly comparing these strategies, the study will determine whether treating limited metastatic disease at the earliest opportunity translates into improved progression-free survival, while also evaluating overall survival, local control, subsequent patterns of progression, time to systemic therapy, toxicity and quality of life.
Age ≥18 years.
Histologically confirmed adenoid cystic carcinoma (ACC) of any primary site.
Oligometastatic disease, defined as 1-5 active radiologically detectable extracranial metastatic lesions involving one or more organs.
Both synchronous/metachronous/ oligoprogressive oligometastatic disease are eligible.
>5 active metastatic lesions at the time of randomization.
Any active metastatic lesion that is not safely amenable to SBRT according to protocol-defined dose and normal-tissue constraints.
Uncontrolled or progressive primary/regional disease requiring immediate local treatment, except for newly diagnosed synchronous disease that has been appropriately managed and is suitable for protocol randomization.
Symptomatic metastatic disease requiring immediate systemic therapy, surgery or palliative radiotherapy.
Parallel
Stereotactic body radiotherapy (SBRT)
RadiationSBRT will be delivered using image-guided, highly conformal radiotherapy with appropriate immobilization and image guidance, using institutionally validated dose-fractionation schedules based on the site, size, number, and proximity of lesions to critical organs. Treatment will be planned to achieve ablative tumor doses while respecting established organ-at-risk constraints. SBRT will preferably be completed within 1-2 weeks.
Progression-free survival (PFS)
The length of time during and after the treatment of a disease, that a patient lives with the disease but it does not get worse.
Overall survival (OS)
The length of time from the start of treatment for the disease, that patients diagnosed with the disease are still alive.
Local control
Radiation Toxicity
using CTCAE version 5.0. : Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental Activities of Daily Living. Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care Activities of Daily Living . Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE.
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