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

NCT07845097 | Not Yet Recruiting Phase 2

• 1 other identifier: AIIMS SABR Oligo-ACC Trial
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Adenoid Cystic Carcinoma; Oligometastatic

Outcome Measures

Primary Outcomes (1)

• 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.

  5 years

Secondary Outcomes (3)

• Overall survival (OS)

  assessed at follow up visits 1 to 10 years

• Local control

  5 years

• Radiation Toxicity

  5 years

Study Arms (2)

SBRT ARM

EXPERIMENTAL

Comprehensive SBRT to all active metastatic lesions that are safely amenable to stereotactic treatment.

Radiation: Stereotactic body radiotherapy (SBRT)

Active surveillance

NO INTERVENTION

Observation with scheduled clinical and radiological assessment, with initiation of local or systemic treatment if clinically indicated.

Interventions

Stereotactic body radiotherapy (SBRT) RADIATION

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.

SBRT ARM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• All active metastatic lesions must be amenable to comprehensive SBRT.
• Controlled primary tumor or loco-regional disease amenable to sugery and radiotherapy
• ECOG Performance Status 0-2.
• Adequate organ function to undergo SBRT and protocol-specified investigations.
• Ability and willingness to comply with study assessments and follow-up.
• Written informed consent.

You may not qualify if:

• \>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.
• 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.
• Active untreated CNS metastases requiring surgery, SRS or other CNS-directed treatment.
• Oligoinduced disease during active systemic therapy.
• Concurrent systemic anticancer therapy at randomization or during protocol-defined SBRT.
• Previous radiotherapy that precludes safe delivery of protocol-specified SBRT because of cumulative dose constraints.
• Another active malignancy requiring treatment or likely to interfere with assessment of ACC-related outcomes.
• Uncontrolled intercurrent illness or medical condition that would preclude protocol treatment or follow-up.
• Pregnancy or lactation.
• Inability or unwillingness to provide informed consent or comply with study procedures.

Sponsors & Collaborators

• All India Institute of Medical Sciences: lead

Related Publications (6)

• Geiger JL, Ismaila N, Beadle B, Caudell JJ, Chau N, Deschler D, Glastonbury C, Kaufman M, Lamarre E, Lau HY, Licitra L, Moore MG, Rodriguez C, Roshal A, Seethala R, Swiecicki P, Ha P. Management of Salivary Gland Malignancy: ASCO Guideline. J Clin Oncol. 2021 Jun 10;39(17):1909-1941. doi: 10.1200/JCO.21.00449. Epub 2021 Apr 26.

  PMID: 33900808 BACKGROUND

• Phillips R, Shi WY, Deek M, Radwan N, Lim SJ, Antonarakis ES, Rowe SP, Ross AE, Gorin MA, Deville C, Greco SC, Wang H, Denmeade SR, Paller CJ, Dipasquale S, DeWeese TL, Song DY, Wang H, Carducci MA, Pienta KJ, Pomper MG, Dicker AP, Eisenberger MA, Alizadeh AA, Diehn M, Tran PT. Outcomes of Observation vs Stereotactic Ablative Radiation for Oligometastatic Prostate Cancer: The ORIOLE Phase 2 Randomized Clinical Trial. JAMA Oncol. 2020 May 1;6(5):650-659. doi: 10.1001/jamaoncol.2020.0147.

  PMID: 32215577 BACKGROUND

• Lorini L, Ardighieri L, Bozzola A, Romani C, Bignotti E, Buglione M, Guerini A, Lombardi D, Deganello A, Tomasoni M, Bonini SA, Sigala S, Farina D, Ravanelli M, Bossi P. Prognosis and management of recurrent and/or metastatic head and neck adenoid cystic carcinoma. Oral Oncol. 2021 Apr;115:105213. doi: 10.1016/j.oraloncology.2021.105213. Epub 2021 Feb 9.

  PMID: 33578204 BACKGROUND

• Tyan K, Bae JE, Lorch JH, Margalit DN, Tishler RB, Huynh MA, Jo VY, Haddad RI, Chau NG, Hanna GJ, Schoenfeld JD. Oligometastatic adenoid cystic carcinoma: Correlating tumor burden and time to treatment with outcomes. Head Neck. 2022 Mar;44(3):722-734. doi: 10.1002/hed.26964. Epub 2021 Dec 19.

  PMID: 34927307 BACKGROUND

• Palma DA, Olson R, Harrow S, Gaede S, Louie AV, Haasbeek C, Mulroy L, Lock M, Rodrigues GB, Yaremko BP, Schellenberg D, Ahmad B, Senthi S, Swaminath A, Kopek N, Liu M, Moore K, Currie S, Schlijper R, Bauman GS, Laba J, Qu XM, Warner A, Senan S. Stereotactic Ablative Radiotherapy for the Comprehensive Treatment of Oligometastatic Cancers: Long-Term Results of the SABR-COMET Phase II Randomized Trial. J Clin Oncol. 2020 Sep 1;38(25):2830-2838. doi: 10.1200/JCO.20.00818. Epub 2020 Jun 2.

  PMID: 32484754 BACKGROUND

• Palma DA, Olson R, Harrow S, Gaede S, Louie AV, Haasbeek C, Mulroy L, Lock M, Rodrigues GB, Yaremko BP, Schellenberg D, Ahmad B, Griffioen G, Senthi S, Swaminath A, Kopek N, Liu M, Moore K, Currie S, Bauman GS, Warner A, Senan S. Stereotactic ablative radiotherapy versus standard of care palliative treatment in patients with oligometastatic cancers (SABR-COMET): a randomised, phase 2, open-label trial. Lancet. 2019 May 18;393(10185):2051-2058. doi: 10.1016/S0140-6736(18)32487-5. Epub 2019 Apr 11.

  PMID: 30982687 BACKGROUND

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Department of Radiation Oncology, NCI, AIIMS, Jhajjar

Study Record Dates

• First Submitted: September 22, 2026
• First Posted: September 28, 2026
• Study Start (Estimated): December 20, 2026
• Primary Completion (Estimated): December 20, 2032
• Study Completion (Estimated): December 20, 2032
• Last Updated: September 28, 2026

Record last verified: 2026-09