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

ConditionsAdenoid Cystic CarcinomaMetastatic Adenoid Cystic Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute

About this trial

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)

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standard of Care

    Other intervention

    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

Treatment groups

32 Participants
are divided into 3 treatment groups
Group A: Standard of Care (Cohort 1)Active comparator 1 intervention
Group B: Stereotactic Body Radiotherapy (SBRT) 1-5 Metastatic Sites (Cohort 1)Experimental treatment 1 intervention
Group C: Local Ablative Therapy (Cohort 2)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Progression Free Survival (PFS) (Cohort 1)

Assessed using RECIST v1.1 and Kaplan-Meier

Time frame
Time from randomization to local, regional, distant progression or death due to any cause, whichever occurs first, assessed up to 5 years
2

Local Control Rate (Cohort 2)

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

Time frame
2 years from enrollment

Secondary outcomes

1

Overall Survival (OS)

Assessed using RECIST v1.1 and Kaplan-Meier

Time frame
Time from randomization to death from any cause or date last known alive, assessed up to 5 years
2

Toxicity Rate

Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Time frame
Enrollment to end of treatment up to 2 years
3

Quality of Life (QOL) assessments by FACT-G

Descriptive statistics will be performed to characterize QOL data

Time frame
Baseline and every 3 months for 2 years
4

Local Disease Control Rate

Free of locoregional progression within irradiated oligometastatic sites, assessed using Kaplan-Meier

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Dana-Farber Cancer Institute

Lead sponsor

Adenoid Cystic Carcinoma Research Foundation

Collaborator

Gateway for Cancer Research

Collaborator

Source ClinicalTrials.gov
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