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

Part of paid clinical trials in San Francisco, California.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT04883671
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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).
  • SBRT — RADIATION
    SBRT to 1-5 sites of metastatic disease over the course of 1-8 business days to each area of cancer

Study Details

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 Dates

Start date
Dec 27, 2021
Status verified
Sep 2025
Primary completion
Jun 1, 2028
Completion
Jun 1, 2030

Study Design

Enrollment
32 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Standard of Care (Cohort 1)
    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).
  • Experimental: Stereotactic Body Radiotherapy (SBRT) 1-5 Metastatic Sites (Cohort 1)
    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.
  • No Intervention: Local Ablative Therapy (Cohort 2)
    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.

Primary Outcome Measure

Progression Free Survival (PFS) (Cohort 1) [ Time Frame: Time from randomization to local, regional, distant progression or death due to any cause, whichever occurs first, assessed up to 5 years ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94158
Sue Yom, MD, PhD
[email protected]
877-827-3222
Sue Yom, MD, PhD (PRINCIPAL_INVESTIGATOR)
University of ChicagoChicagoIllinois60637
Alexander T Pearson, MD, PhD
[email protected]
855-702-8222
Alexander T Pearson, MD, PhD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02115
Jonathan D Schoenfeld, MD, MPH
[email protected]
617.632.5296
Jonathan D Schoenfeld, MD, MPH (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
Jonathan D Schoenfeld, MD, MPH
[email protected]
617-632-5296
Jonathan D Schoenfeld, MD, MPH (PRINCIPAL_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Matthew S Ning, MD, MPH
[email protected]
832-710-8779
Matthew S Ning, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
University of California, San Francisco· San Francisco, CAUniversity of Chicago· Chicago, ILBrigham and Women's Hospital· Boston, MADana Farber Cancer Institute· Boston, MAMD Anderson Cancer Center· Houston, TX

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