Stereotactic Body Radiotherapy (SBRT) for Oligometastatic Adenoid Cystic Carcinoma
This study is looking at whether early treatment with Stereotactic Body Radiotherapy (SBRT) can help people with adenoid cystic carcinoma that has spread to a few other places in the body (oligometastatic). SBRT is a very focused type of radiation. You would be randomly assigned to either receive SBRT to 1-5 areas of cancer, or standard care which might include other radiation or medicines like chemotherapy. The study wants to see if SBRT affects how long it takes for the cancer to progress, your quality of life, and how long people live. To join, you need to be 18 or older with adenoid cystic carcinoma that has spread, and have 1 to 5 spots of cancer. The study aims to enroll 32 people, but its current status is unclear.
- Study design
- This is a randomized, open-label study with two groups, aiming to enroll 32 participants. It is a Phase II study.
- What's involved
- You would undergo screening to see if you qualify, receive study treatment, and have evaluations and follow-up visits. SBRT treatment involves 1-8 business days of radiation to each cancer area.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your progression-free survival will be measured for up to 5 years, and local control rate will be measured for 2 years from enrollment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT04883671
Stereotactic Body Radiotherapy (SBRT) for Early Treatment of Oligometastatic Adenoid Cystic Carcinoma: The SOLAR Trial
Recruiting
NAAges 18+InterventionalTreatmentDana-Farber Cancer InstituteInvestigator-initiated
~32 participants
Updated 2025-09-23 on ClinicalTrials.gov
What's tested:Standard of CareSBRT
At a glance
Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival (PFS) (Cohort 1)
Measured over Time from randomization to local, regional, distant progression or death due to any cause, whichever occurs first, assessed up to 5 years
+1 more outcome measured
Conditions
Where it's being run
5 sites across 4 statesMassachusetts2
California1
Illinois1
Texas1
Study leadership
- Jonathan D Schoenfeld, MD, MPH · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Subject must have histologically confirmed adenoid cystic carcinoma (ACC) of any primary site with distant metastases detected clinically or on imaging (biopsy of metastatic disease preferred, but not required)
Cohort 1
One to five detectable sites of metastatic disease at any organ or site (including bone and CNS involvement)
Maximum size of 3 cm for brain lesions.
Note: Measurable disease is not required
Note: Patients with isolated intracranial disease for whom SRS would be the preferred standard of care are not eligible.
Note: Patients may have additional sites of disease for which radiation is not feasible or indicated provided this disease is: 1) Less than 1 cm in maximum diameter on most recent imaging; or 2) Stable over the last 3 months as determined by the investigator
Cohort 2
At least 1 site of non-osseous disease
Cohort 1
All (up to 5) metastatic foci should be amenable to SBRT as per review by a radiation oncologist based on protocol specified dose / dose constraints (there is no prespecified minimum or maximum size)
Cohort 2
At least one metastatic focus amenable to local ablative treatment with any of the following: radiation therapy; radiofrequency, microwave, or cryoablation; bland or chemoembolization
Cohort 1
Primary tumor either controlled, or amenable for local treatment with SBRT
Defined as no evidence of progression at primary or local site of disease (if known) within 6 months prior to enrollment
Age 18 years or older
ECOG performance status of 0-2
Prior systemic therapy is allowed but no therapy (cytotoxic or molecularly targeted agents) 2 weeks prior to the first fraction of radiotherapy, and until after the last fraction of SBRT.
Cohort 1
For patients with metastases that have been previously treated (prior resection, radiotherapy, radiofrequency or cryoablation):
If the previously treated site is controlled based on imaging, the patient is eligible for this trial and does not need further treatment of the controlled site
If the previously treated site is not controlled based on imaging, the patient is eligible for this trial as long as the site is amenable to SBRT
Ability to understand and the willingness to sign a written informed consent document.
Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of (chemo)radiation therapy.
Men who are sexually active with WOCBP must agree to use any contraceptive method with a failure rate of less than 1% per year. Men who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 1 month after treatment. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception. See Appendix B for further guidance on contraception.
Exclusion
Cohort 1
Subject who has received systemic therapy for treatment of ACC within 2 weeks of enrollment.
Evidence of need for urgent surgical intervention for metastatic CNS or spine disease.
Cohort 1
Alternative locally ablative therapies received (radiofrequency ablation, cryotherapy, or \[chemo\]embolization) for any metastatic foci planned for SBRT at the time of study enrollment that precludes administration of SBRT.
Bone metastasis in a femoral bone for which surgical stabilization is recommended.
Cohort 1
Active disease \>1 cm that is progressing and not amenable to SBRT.
Pregnant or lactating women.
Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
Has a known additional malignancy that is progressing or requires active treatment. Exceptions: include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer, and low-risk prostate adenocarcinoma being managed with active surveillance. A history of another separate malignancy in remission without evidence of active disease in the last 2 years is permitted.
What this trial measures
- Progression Free Survival (PFS) (Cohort 1)Time from randomization to local, regional, distant progression or death due to any cause, whichever occurs first, assessed up to 5 years
Assessed using RECIST v1.1 and Kaplan-Meier
- Local Control Rate (Cohort 2)2 years from enrollment
Estimating 2-year local control rate following local treatment of ACC lesions. Assessed using RECIST v1.1.