Phase II Trial Comparing Stereotactic Body Radiotherapy Versus Active Surveillance for Oligometastatic Adenoid Cystic Carcinoma

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.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

1. Age ≥18 years.
2. Histologically confirmed adenoid cystic carcinoma (ACC) of any primary site.
3. Oligometastatic disease, defined as 1-5 active radiologically detectable extracranial metastatic lesions involving one or more organs.
4. Both synchronous/metachronous/ oligoprogressive oligometastatic disease are eligible.
5. All active metastatic lesions must be amenable to comprehensive SBRT.
6. Controlled primary tumor or loco-regional disease amenable to sugery and radiotherapy
7. ECOG Performance Status 0-2.
8. Adequate organ function to undergo SBRT and protocol-specified investigations.
9. Ability and willingness to comply with study assessments and follow-up.
10. Written informed consent.

Exclusion Criteria:

1. \>5 active metastatic lesions at the time of randomization.
2. Any active metastatic lesion that is not safely amenable to SBRT according to protocol-defined dose and normal-tissue constraints.
3. 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.
4. Symptomatic metastatic disease requiring immediate systemic therapy, surgery or palliative radiotherapy.
5. Metastatic disease associated with an oncological emergency, including impending pathological fracture, spinal cord compression, unstable spinal disease, major airway compromise, major vascular compromise or other condition requiring urgent intervention.
6. Active untreated CNS metastases requiring surgery, SRS or other CNS-directed treatment.
7. Oligoinduced disease during active systemic therapy.
8. Concurrent systemic anticancer therapy at randomization or during protocol-defined SBRT.
9. Previous radiotherapy that precludes safe delivery of protocol-specified SBRT because of cumulative dose constraints.
10. Another active malignancy requiring treatment or likely to interfere with assessment of ACC-related outcomes.
11. Uncontrolled intercurrent illness or medical condition that would preclude protocol treatment or follow-up.
12. Pregnancy or lactation.
13. Inability or unwillingness to provide informed consent or comply with study procedures.

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