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

NCT04883671 | Recruiting DMC FDA Device

• 1 other identifier: 21-171
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 5

Brief Summary

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)

Conditions

Adenoid Cystic Carcinoma; Metastatic Adenoid Cystic Carcinoma

Keywords

Adenoid Cystic Carcinoma; Metastatic Adenoid Cystic Carcinoma

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival (PFS) (Cohort 1)

  Assessed using RECIST v1.1 and Kaplan-Meier

  Time from randomization to local, regional, distant progression or death due to any cause, whichever occurs first, assessed up to 5 years

• Local Control Rate (Cohort 2)

  Estimating 2-year local control rate following local treatment of ACC lesions. Assessed using RECIST v1.1.

  2 years from enrollment

Secondary Outcomes (6)

• Overall Survival (OS)

  Time from randomization to death from any cause or date last known alive, assessed up to 5 years

• Toxicity Rate

  Enrollment to end of treatment up to 2 years

• Quality of Life (QOL) assessments by FACT-G

  Baseline and every 3 months for 2 years

• Local Disease Control Rate

  Time from randomization to free of locoregional progression, assessed up to 5 years

• Time to next systemic therapy for progression of disease

  Time from randomization to initiation of systemic therapy for progression of disease, assessed up to 5 years

Study Arms (3)

Standard of Care (Cohort 1)

ACTIVE COMPARATOR

Participants will be randomly assigned and receive standard of care as determined by their physician and may include: palliative radiation and/or a systemic therapy (like chemotherapy, immunotherapy, or targeted therapies).

Other: Standard of Care

Stereotactic Body Radiotherapy (SBRT) 1-5 Metastatic Sites (Cohort 1)

EXPERIMENTAL

Participants will be randomly assigned and receive SBRT to 1-5 sites of metastatic disease over the course of 1-8 business days to each area of cancer. After SBRT is completed participant may go on to receive systemic therapy (like chemotherapy, immunotherapy, or targeted therapies) per discretion of their treating physician.

Radiation: SBRT

Local Ablative Therapy (Cohort 2)

NO INTERVENTION

Participants embarking on standard of care local ablative therapy (not limited to radiofrequency, microwave, or cryoablation, bland or chemoembolization, palliative radiotherapy, or surgical metastasectomy) not eligible for cohort 1 will be enrolled and followed.

Interventions

Standard of Care OTHER

Participants will be randomly assigned and receive standard of care as determined by their physician and may include: palliative radiation and/or a systemic therapy (like chemotherapy, immunotherapy, or targeted therapies).

Standard of Care (Cohort 1)

SBRT RADIATION

SBRT to 1-5 sites of metastatic disease over the course of 1-8 business days to each area of cancer

Also known as: Stereotactic Body Radiotherapy

Stereotactic Body Radiotherapy (SBRT) 1-5 Metastatic Sites (Cohort 1)

Eligibility Criteria

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

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

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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Adenoid Cystic Carcinoma Research Foundation: collaborator
• Gateway for Cancer Research: collaborator

Study Sites (5)

University of California, San Francisco

San Francisco, California, 94158, United States

RECRUITING

University of Chicago

Chicago, Illinois, 60637, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Carcinoma, Adenoid Cystic

Interventions

Standard of Care; Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Jonathan D Schoenfeld, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan D Schoenfeld, MD, MPH

CONTACT

617-632-5296; jonathan_schoenfeld@dfci.harvard.edu

Glenn J Hanna, MD

CONTACT

617-632-3090; glenn_hanna@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: May 12, 2021
• Study Start: December 27, 2021
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2030
• Last Updated: September 23, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)