A Phase 2 interventional study of Stereotactic body radiotherapy (SBRT) in Adenoid Cystic Carcinoma and Oligometastatic, sponsored by All India Institute of Medical Sciences. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by All India Institute of Medical Sciences · Phase 2, Interventional, and Treatment
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.
102 studies on the registry are indexed under Carcinoma, Adenoid Cystic; 23 are open to participants now.
This study's planned enrollment of 90 is above the median of 35 across 93 interventional studies indexed under Carcinoma, Adenoid Cystic.
Browse Carcinoma, Adenoid Cystic studies →All India Institute of Medical Sciences is the lead sponsor of 21 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Comprehensive SBRT to all active metastatic lesions that are safely amenable to stereotactic treatment.
Radiation: Stereotactic body radiotherapy (SBRT)
Observation with scheduled clinical and radiological assessment, with initiation of local or systemic treatment if clinically indicated.
SBRT 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.
Time frame: 5 years
Overall survival (OS)
The length of time from the start of treatment for the disease, that patients diagnosed with the disease are still alive.
Time frame: assessed at follow up visits 1 to 10 years
Local control
Time frame: 5 years
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.
Time frame: 5 years
No study locations are listed for this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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All India Institute of Medical Sciences