Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04883671

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

Led by Dana-Farber Cancer Institute · Updated on 2025-09-23

32

Participants Needed

5

Research Sites

439 weeks

Total Duration

On this page

Sponsors

D

Dana-Farber Cancer Institute

Lead Sponsor

A

Adenoid Cystic Carcinoma Research Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed adenoid cystic carcinoma (ACC) with distant metastases
  • One to five detectable metastatic sites for Cohort 1; at least one non-bone metastatic site for Cohort 2
  • Maximum size of brain lesions is 3 cm for Cohort 1
  • All metastatic sites in Cohort 1 must be suitable for SBRT treatment
  • Primary tumor controlled or stable without progression within 6 months prior to enrollment for Cohort 1
  • Age 18 years or older
  • ECOG performance status of 0-2
  • Prior systemic therapy allowed except no treatment within 2 weeks before or during SBRT
  • Ability to understand and sign informed consent
  • Women of childbearing potential must have negative pregnancy test before treatment
  • Men sexually active with women of childbearing potential must use contraception during and 1 month after treatment
Not Eligible

You will not qualify if you...

  • Systemic therapy for ACC within 2 weeks before enrollment for Cohort 1
  • Need for urgent surgery for metastatic brain or spine disease
  • Use of alternative local ablative therapies for planned SBRT sites before enrollment for Cohort 1
  • Bone metastasis in femur requiring surgical stabilization
  • Active progressing disease larger than 1 cm not suitable for SBRT for Cohort 1
  • Pregnant or breastfeeding women
  • Uncontrolled illnesses such as severe heart failure, unstable angina, arrhythmia, or psychiatric/social issues limiting compliance
  • Other progressing malignancies requiring treatment, except certain skin cancers, in situ cervical cancer, or low-risk prostate cancer under surveillance
  • History of other cancers in remission less than 2 years ago

AI-Screening

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Trial Site Locations

Total: 5 locations

1

University of California, San Francisco

San Francisco, California, United States, 94158

Actively Recruiting

2

University of Chicago

Chicago, Illinois, United States, 60637

Actively Recruiting

3

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

4

Dana Farber Cancer Institute

Boston, Massachusetts, United States, 02215

Actively Recruiting

5

MD Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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Research Team

J

Jonathan D Schoenfeld, MD, MPH

CONTACT

G

Glenn J Hanna, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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