Stereotactic Body Radiotherapy (SBRT) for Early Treatment of Oligometastatic Adenoid Cystic Carcinoma: The SOLAR Trial
Dana-Farber Cancer Institute
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)
Description
This is a randomized phase II, open-label and non-blinded two-arm study aimed to investigate the potential benefit of treating oligometastatic adenoid cystic carcinoma (ACC) with early initiation of stereotactic body radiotherapy (SBRT). Given the overall uncertainty about the role of local therapy in the treatment of ACC, there is also a prospective observational cohort that will investigate outcomes following local ablative treatments in patients with advanced or metastatic ACC. This research study is investigating how the specialized and focused stereotactic body radiation therapy (SBRT) i…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion 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…
Interventions
- OtherStandard of Care
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).
- RadiationSBRT
SBRT to 1-5 sites of metastatic disease over the course of 1-8 business days to each area of cancer
Locations (5)
- University of California, San FranciscoSan Francisco, California
- University of ChicagoChicago, Illinois
- Brigham and Women's HospitalBoston, Massachusetts
- Dana Farber Cancer InstituteBoston, Massachusetts
- MD Anderson Cancer CenterHouston, Texas