SABR Oligo-ACC Trial: A Randomized Phase II Trial Comparing Stereotactic Body Radiotherapy Versus Active Surveillance for Oligometastatic Adenoid Cystic Carcinoma
| Registry | NCT07845097 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 2 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 90 (Estimated) |
| Sponsor | All India Institute of Medical Sciences (Other) |
| Conditions | Adenoid Cystic Carcinoma, Oligometastatic |
| Interventions | Stereotactic body radiotherapy (SBRT) (Radiation) |
| Dates | start 2026-12-20 (estimated), primary completion 2032-12-20 (estimated), completion 2032-12-20 (estimated), first posted 2026-09-28, last updated 2026-09-28 |
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All trials for Adenoid Cystic Carcinoma All trials for Oligometastatic All trials of Stereotactic body radiotherapy (SBRT)
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.
The oligometastatic state represents a potentially distinct phase of cancer dissemination in which eradication of all visible metastatic disease may alter subsequent disease progression. Prospective randomized trials in several solid tumors have provided evidence supporting this paradigm. In the phase II SABR-COMET trial, patients with a controlled primary tumor and 1-5 metastases randomized to comprehensive SABR had longer overall survival than those receiving standard treatment alone (median 41 vs 28 months; HR 0.57). Long-term follow-up demonstrated a 5-year overall survival of 42.3% with SABR versus 17.7% with standard treatment. There is robust prospective evidence that metastasis-directed therapy can modify the course of oligometastatic disease; however, their findings cannot be directly extrapolated to adenoid cystic carcinoma (ACC), which has distinct tumor biology and natural history.
A recent retrospective study has demonstrated that patients with oligometastatic ACC had more favorable outcomes than patients with higher metastatic burden, and that early initiation of local treatment was associated with improvement in PFS. However, these observations are subject to selection and other inherent biases of retrospective studies and cannot establish that local ablative therapy itself improves survival or progression-free survival.
The SABR Oligo-ACC Trial is therefore proposed as a randomized, phase II study comparing early initiation of SBRT to all metastases versus active surveillance in patients with oligometastatic ACC.
90 patients with histologically confirmed ACC of any primary site along with oligometastatic disease (1-5 active radiologically detectable extracranial metastatic lesions involving one or more organs) will be participating in this study.
They will be randomized (computer-generated randomization system) in a 1:1 ratio to either Stereotactic Body Radiotherapy (SBRT) or Active Surveillance.
Arm A=SBRT to all oligometastasis Arm B =Active surveillance Overall survival (OS), Progression Free Survival (PFS), Local Control of metatstatic lesion, SBRT toxicity (CTCAE version 5.0) and Quality of life (EORTC QLQ C-30) will be assessed at different timelines.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| SBRT ARM | Experimental | Radiation: Stereotactic body radiotherapy (SBRT) | Comprehensive SBRT to all active metastatic lesions that are safely amenable to stereotactic treatment. |
| Active surveillance | No intervention | Observation with scheduled clinical and radiological assessment, with initiation of local or systemic treatment if clinically indicated. |
Sex: All, ages: 18 Years to any
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.