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

Eligibility Criteria

• * 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.
• * 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.