Stereotactic Body Radiotherapy (SBRT) for Early Treatment of Oligometastatic Adenoid Cystic Carcinoma: The SOLAR Trial

Recruiting now · Not applicable

Conditions studied: Adenoid Cystic Carcinoma, Metastatic Adenoid Cystic Carcinoma

In brief

The aim of this study is to learn whether the early initiation of a specialized and focused type of radiation called stereotactic body radiation therapy (SBRT) will impact the progression of advanced adenoid cystic carcinoma, quality of life, and overall survival. The name(s) of the study intervention involved in this study is: * Stereotactic Body Radiation Therapy (SBRT)

Key facts

Study ID

NCT04883671

Run by

Dana-Farber Cancer Institute

People needed

32

Starts

2021-12-27

Expected to finish

2030-06-01

Last updated by the study team

2025-09-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• University of California, San Francisco — San Francisco, California, United States (enrolling)
• University of Chicago — Chicago, Illinois, United States (enrolling)
• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• MD Anderson Cancer Center — Houston, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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