BridgeMD
New treatment option for Adenoid Cystic Carcinoma
Official title Stereotactic Body Radiotherapy (SBRT) for Early Treatment of Oligometastatic Adenoid Cystic Carcinoma: The SOLAR Trial
ClinicalTrials.gov ID: NCT04883671
What this study is testing
- What it's testing
- 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)
- Time commitment: about 10 years
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Subject must have histologically confirmed adenoid cystic carcinoma (ACC) of any primary site with distant metastases detected clinically or on...
- 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
You likely can't join if
- 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
- Alternative locally ablative therapies received (radiofrequency ablation, cryotherapy, or [chemo]embolization) for any metastatic foci planned for...
- Bone metastasis in a femoral bone for which surgical stabilization is recommended.
See the full eligibility 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 may have additional sites of disease for which radiation is not feasible or indicated provided this disease is: 1) Less than 1 cm in maximum diameter on most recent imaging; or 2) Stable over the last 3...
- Cohort 2
- At least 1 site of non-osseous disease
- Cohort 1
- All (up to 5) metastatic foci should be amenable to SBRT as per review by a radiation oncologist based on protocol specified dose / dose constraints (there is no prespecified minimum or maximum size)
- Cohort 2
- At least one metastatic focus amenable to local ablative treatment with any of the following: radiation therapy; radiofrequency, microwave, or cryoablation; bland or chemoembolization
- Cohort 1
- Primary tumor either controlled, or amenable for local treatment with SBRT
- Defined as no evidence of progression at primary or local site of disease (if known) within 6 months prior to enrollment
- Age 18 years or older
- ECOG performance status of 0-2
- Prior systemic therapy is allowed but no therapy (cytotoxic or molecularly targeted agents) 2 weeks prior to the first fraction of radiotherapy, and until after the last fraction of SBRT.
- Cohort 1
- For patients with metastases that have been previously treated (prior resection, radiotherapy, radiofrequency or cryoablation):
- If the previously treated site is controlled based on imaging, the patient is eligible for this trial and does not need further treatment of the controlled site
- If the previously treated site is not controlled based on imaging, the patient is eligible for this trial as long as the site is amenable to SBRT
- Ability to understand and the willingness to sign a written informed consent document.
- Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of (chemo)radiation therapy. "Women of...
- Men who are sexually active with WOCBP must agree to use any contraceptive method with a failure rate of less than 1% per year. Men who are sexually active with WOCBP will be instructed to adhere to contraception for a...
- 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
- Alternative locally ablative therapies received (radiofrequency ablation, cryotherapy, or [chemo]embolization) for any metastatic foci planned for SBRT at the time of study enrollment that precludes administration of...
- Bone metastasis in a femoral bone for which surgical stabilization is recommended.
- Cohort 1
- Active disease \>1 cm that is progressing and not amenable to SBRT.
- Pregnant or lactating women.
- Uncontrolled intercurrent illness including, but not limited to, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance...
- Has a known additional malignancy that is progressing or requires active treatment. Exceptions: include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative...
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 10 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.