32 Participants Needed

SBRT for Adenoid Cystic Carcinoma

Recruiting at 3 trial locations
JD
GJ
JD
Glenn J. Hanna, MD profile photo
Overseen ByGlenn J. Hanna, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Dana-Farber Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of 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)

Will I have to stop taking my current medications?

You will need to stop any systemic therapy (like certain cancer drugs) at least 2 weeks before starting the radiation treatment and until after the last session of SBRT. Other medications are not specifically mentioned, so it's best to discuss with the trial team.

Is stereotactic body radiation therapy (SBRT) generally safe for humans?

Stereotactic body radiation therapy (SBRT), also known as stereotactic ablative radiotherapy (SABR), is generally considered safe for treating various tumors, but some serious complications have been reported. The risk of side effects can vary depending on the location of the tumor, with higher risks near sensitive structures like the bronchial tree. Strategies are in place to reduce these risks and improve safety.12345

How is SBRT treatment different for adenoid cystic carcinoma?

SBRT (Stereotactic Body Radiation Therapy) is unique because it delivers high doses of radiation precisely to the tumor while sparing surrounding healthy tissue, which is particularly beneficial for treating lung metastases from adenoid cystic carcinoma that are resistant to conventional radiotherapy.678910

What data supports the effectiveness of the treatment SBRT for Adenoid Cystic Carcinoma?

Stereotactic Body Radiation Therapy (SBRT) has shown effectiveness in treating various cancers, such as non-small cell lung cancer, by delivering precise, high doses of radiation to tumors while minimizing damage to surrounding healthy tissue. This approach has been associated with high local control rates and low toxicity, suggesting potential benefits for treating other types of tumors, including Adenoid Cystic Carcinoma.111121314

Who Is on the Research Team?

JD

Jonathan D. Schoenfeld, MD MPH

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

This trial is for adults with adenoid cystic carcinoma that has spread to other parts of the body. Participants should have 1-5 metastatic sites, a stable primary tumor, and an ECOG performance status of 0-2. Women must not be pregnant and agree to contraception measures. No recent systemic therapy (4 weeks before radiotherapy) is allowed.

Inclusion Criteria

I can take care of myself and am up and about more than half of the day.
I have 1 to 5 areas where cancer has spread, including in bones or brain.
My primary cancer has not worsened in the last 6 months.
See 9 more

Exclusion Criteria

I need urgent surgery for cancer spread to my brain or spine.
Pregnant or lactating women
I have cancer spread to my thigh bone and need surgery to stabilize it.
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive stereotactic body radiotherapy (SBRT) to 1-5 sites of metastatic disease over the course of 1-8 business days

1-2 weeks
1-8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments for progression-free survival and overall survival

5 years
Regular follow-up visits up to 5 years

Optional Systemic Therapy

Participants may receive systemic therapy such as chemotherapy, immunotherapy, or targeted therapies at the discretion of their treating physician after SBRT

What Are the Treatments Tested in This Trial?

Interventions

  • SBRT
Trial Overview The SOLAR Trial is testing if starting stereotactic body radiation therapy (SBRT) early can affect the progression of advanced adenoid cystic carcinoma, improve quality of life, or increase survival compared to standard care.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Active Control
Group I: Stereotactic Body Radiotherapy (SBRT) 1-5 Metastatic Sites (Cohort 1)Experimental Treatment1 Intervention
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.
Group II: Standard of Care (Cohort 1)Active Control1 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).
Group III: Local Ablative Therapy (Cohort 2)Active Control1 Intervention
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.

SBRT is already approved in United States, European Union, Canada, Japan for the following indications:

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Approved in United States as SBRT for:
  • Prostate cancer
  • Lung cancer
  • Liver cancer
  • Pancreatic cancer
  • Spinal tumors
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Approved in European Union as SBRT for:
  • Prostate cancer
  • Lung cancer
  • Liver cancer
  • Pancreatic cancer
  • Spinal tumors
  • Bone metastases
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Approved in Canada as SBRT for:
  • Prostate cancer
  • Lung cancer
  • Liver cancer
  • Pancreatic cancer
  • Spinal tumors
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Approved in Japan as SBRT for:
  • Prostate cancer
  • Lung cancer
  • Liver cancer
  • Pancreatic cancer

Find a Clinic Near You

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials
1,128
Recruited
382,000+

Adenoid Cystic Carcinoma Research Foundation

Collaborator

Trials
3
Recruited
80+

Gateway for Cancer Research

Collaborator

Trials
47
Recruited
2,500+

Adenoid Cystic Carcinoma Research Foundation

Collaborator

Trials
7
Recruited
160+

Published Research Related to This Trial

In a study of 31 patients with previously irradiated malignant skull base tumors treated with stereotactic ablative radiotherapy (SABR), the treatment demonstrated low toxicity, with no severe (grade 4 or 5) side effects reported.
The estimated 1-year overall survival rate was 35%, indicating that while SABR is well-tolerated, the survival outcomes for these patients remain limited, with a median time-to-progression of 3.3 months.
Stereotactic ablative radiosurgery for locally advanced or recurrent skull base malignancies with prior external beam radiation therapy.Xu, KM., Quan, K., Clump, DA., et al.[2020]
Stereotactic ablative body radiosurgery (SABR) and stereotactic body radiation therapy (SBRT) deliver high doses of radiation precisely to tumors, which may improve treatment outcomes compared to conventional low-dose radiation therapy (1.8-2Gy).
These advanced techniques not only enhance tumor ablation but also interact beneficially with biological and immunologic therapies, while incorporating methods to protect normal tissues, making them suitable for various types of cancer.
Stereotactic ablative body radiosurgery (SABR) or Stereotactic body radiation therapy (SBRT).Folkert, MR., Timmerman, RD.[2022]
Stereotactic body radiation therapy (SBRT) is a preferred treatment for early-stage non-small cell lung cancer (NSCLC) patients who cannot undergo surgery, but accurate lymph node staging is crucial for optimal patient selection.
Current staging methods like PET/CT and EBUS have limited sensitivity in detecting lymph node metastases, which can lead to undetected cancer spread and poorer outcomes; thus, invasive staging procedures are often necessary to improve detection and potentially enhance survival with adjuvant therapies.
Undetected lymph node metastases in presumed early stage NSCLC SABR patients.Cerra-Franco, A., Diab, K., Lautenschlaeger, T.[2017]

Citations

Stereotactic ablative radiosurgery for locally advanced or recurrent skull base malignancies with prior external beam radiation therapy. [2020]
Stereotactic ablative body radiosurgery (SABR) or Stereotactic body radiation therapy (SBRT). [2022]
Undetected lymph node metastases in presumed early stage NSCLC SABR patients. [2017]
Stereotactic ablative radiotherapy for small lung tumors with a moderate dose. Favorable results and low toxicity. [2022]
Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. [2013]
Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. [2018]
Incidence and risk factors for chest wall toxicity after risk-adapted stereotactic radiotherapy for early-stage lung cancer. [2022]
An optimal dose-fractionation for stereotactic body radiotherapy in peripherally, centrally and ultracentrally located early-stage non-small lung cancer. [2023]
Safety and Effectiveness of Stereotactic Ablative Radiotherapy for Ultra-Central Lung Lesions: A Systematic Review. [2020]
Stereotactic body radiotherapy for adenoid cystic carcinoma metastatic to the lung: a case report. [2021]
11.United Statespubmed.ncbi.nlm.nih.gov
A Rare Case of Unresectable Adenoid Cystic Carcinoma of the Nasopharynx Treated with Intensity Modulated Proton Therapy. [2020]
Long-Term Outcomes of Personalized Stereotactic Ablative Brachytherapy for Recurrent Head and Neck Adenoid Cystic Carcinoma after Surgery or External Beam Radiotherapy: A 9-Year Study. [2021]
13.United Statespubmed.ncbi.nlm.nih.gov
Outcomes and prognostic variables in adenoid cystic carcinoma of the head and neck: a recent experience. [2022]
Particle Beam Radiation Therapy for Adenoid Cystic Carcinoma of the Nasal Cavity and Paranasal Sinuses. [2020]
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