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)
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) impacts disease progression, quality of life, and overall survival in patients with a limited number of metastases (one to five) from their adenoid cystic carcinoma cancer. The use of SBRT to treat all areas of disease after early spread of ACC is investigational. SBRT is a more focused form of radiation compared to the palliative radiation typically received per standard of care treatment. Recent retrospective studies conducted suggest that patients with adenoid cystic carcinoma cancer may benefit from early initiation of a targeted radiation therapy. The research study procedures include screening for eligibility and study treatment including evaluations and follow up visits. After enrollment participants will be randomized into two groups: Standard of Care or Stereotactic body radiotherapy (SBRT). All participants in the study, regardless of treatment regimen, will be followed for up to 10 years. It is expected that about 32 people will take part in this research study. Two organizations, Gateway for Cancer Research and the Adenoid Cystic Carcinoma Research Foundation (ACCRF), are supporting this research study by providing funding.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
32
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 to 1-5 sites of metastatic disease over the course of 1-8 business days to each area of cancer
University of California, San Francisco
San Francisco, California, United States
RECRUITINGUniversity of Chicago
Chicago, Illinois, United States
RECRUITINGBrigham and Women's Hospital
Boston, Massachusetts, United States
RECRUITINGDana Farber Cancer Institute
Boston, Massachusetts, United States
RECRUITINGMD Anderson Cancer Center
Houston, Texas, United States
RECRUITINGProgression 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
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
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
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
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
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
Time to next systemic therapy for progression of disease
Assessed using Kaplan-Meier
Time frame: Time from randomization to initiation of systemic therapy for progression of disease, assessed up to 5 years
Time to local therapy for progression of disease
Assessed using Kaplan-Meier
Time frame: Time from randomization to initiation of local therapy for progression of disease, assessed up to 5 years
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