SBRT for Adenoid Cystic Carcinoma

Recruiting at 3 trial locations

Overseen by Jonathan D. Schoenfeld, MD MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Dana-Farber Cancer Institute

Must not be taking: Cytotoxic agents

Disqualifiers: Pregnancy, Urgent surgery, Uncontrolled illness, others

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{10 11 12 13 14}

Research Team

Jonathan D. Schoenfeld, MD MPH

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

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 am 18 years old or older.

I have 1 to 5 areas where cancer has spread, including in bones or brain.

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.

Trial Timeline

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

Treatment Details

Interventions

• SBRT (Radiation Therapy)

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.

Participant Groups

Group I: Stereotactic Body Radiotherapy (SBRT) 1-5 Metastatic Sites (Cohort 1) Experimental Treatment 1 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 Control 1 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 Control 1 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 Canada, Japan for the following indications:

Approved in Canada as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer
• Spinal tumors

Approved in Japan as SBRT for:

• Prostate cancer
• Lung cancer
• Liver cancer
• Pancreatic cancer

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

Dr. Benjamin L. Ebert

Dana-Farber Cancer Institute

Chief Executive Officer

MD from Harvard Medical School, PhD from Oxford University

Dr. Craig A. Bunnell

Dana-Farber Cancer Institute

Chief Medical Officer since 2012

MD from Harvard Medical School, MPH from Harvard School of Public Health, MBA from MIT Sloan School of Management

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+

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Undetected lymph node metastases in presumed early stage NSCLC SABR patients. Cerra-Franco, A., Diab, K., Lautenschlaeger, T.[2017]

In a study of 39 patients with 45 lung lesions treated with stereotactic ablative body radiotherapy (SBRT), local progression-free survival rates were high, with 90.5% at 1 year and 80.5% at 2 years, indicating effective tumor control.

The treatment was well-tolerated with only mild acute side effects, suggesting that the moderate dose schedules of 35 Gy (5 fractions) or 37.5 Gy (3 fractions) are safe and effective for managing non-small cell lung cancer and metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy for small lung tumors with a moderate dose. Favorable results and low toxicity. Duncker-Rohr, V., Nestle, U., Momm, F., et al.[2022]

Stereotactic ablative radiotherapy (SABR) is an effective treatment for early-stage non-small cell lung cancers (NSCLCs) that are medically inoperable, providing local control and toxicity levels comparable to surgical resection.

SABR is gaining interest as a noninvasive treatment option for patients with borderline resectable lung cancers, although further randomized studies are needed to evaluate its survival benefits in operable patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. Iyengar, P., Westover, K., Timmerman, RD.[2013]

Stereotactic ablative radiotherapy (SABR) has rapidly expanded in clinical use for treating various primary and metastatic tumors, demonstrating promising results in tumor control.

Despite its effectiveness, SABR can lead to serious complications, highlighting the need for strategies to reduce these risks and improve the safety of the treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. Lo, SS., Sahgal, A., Chang, EL., et al.[2018]

In a study of 500 patients treated with stereotactic ablative body radiotherapy (SABR) for stage I non-small cell lung cancer, severe chest wall pain (CWP) occurred in only 2% of patients, indicating that serious toxicity is rare with this treatment.

The study found that larger treatment volumes and closer tumor-chest wall distances were associated with increased risk of CWP and rib fractures, suggesting that careful planning of radiation doses can help minimize these risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and risk factors for chest wall toxicity after risk-adapted stereotactic radiotherapy for early-stage lung cancer. Bongers, EM., Haasbeek, CJ., Lagerwaard, FJ., et al.[2022]

Stereotactic body radiotherapy (SBRT) is effective for treating early-stage non-small cell lung cancer (NSCLC) in patients who cannot undergo surgery, showing good outcomes and low toxicity for tumors located in the periphery.

However, the risk of severe toxicity increases for tumors near critical structures like the bronchial tree or mediastinum, highlighting the importance of careful dose-fractionation planning in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An optimal dose-fractionation for stereotactic body radiotherapy in peripherally, centrally and ultracentrally located early-stage non-small lung cancer. Zarębska, I., Harat, M.[2023]

Stereotactic ablative radiotherapy (SABR) for ultra-central lung tumors shows a high median local control rate of 96% at one year, indicating its effectiveness in managing these challenging lesions.

However, there is a significant risk of severe treatment-related toxicity, particularly in patients with endobronchial disease or those receiving high doses to the bronchial tree, highlighting the need for careful patient selection and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Effectiveness of Stereotactic Ablative Radiotherapy for Ultra-Central Lung Lesions: A Systematic Review. Chen, H., Laba, JM., Zayed, S., et al.[2020]

A 76-year-old man with adenoid cystic carcinoma (ACC) successfully treated multiple lung metastases using stereotactic body radiotherapy (SBRT) with CyberKnife, delivering a high dose of 60 Gy in 10 fractions, resulting in no tumor recurrence after 21 months.

Despite experiencing acute radiation pneumonitis, the patient had no late toxicity, indicating that SBRT with CyberKnife is a safe and effective treatment option for managing lung metastases from ACC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for adenoid cystic carcinoma metastatic to the lung: a case report. Kobayashi, D., Abe, T., Saitoh, JI., et al.[2021]

Adenoid cystic carcinoma (ACC) can be effectively treated with intensity modulated proton therapy (IMPT) in cases where surgical options are not viable, as demonstrated in a case of unresectable Stage T4N0 ACC.

The treatment resulted in good local control of the tumor without significant late toxicity, highlighting the potential safety and efficacy of IMPT for challenging ACC cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Rare Case of Unresectable Adenoid Cystic Carcinoma of the Nasopharynx Treated with Intensity Modulated Proton Therapy. Phan, J., Ng, SP., Pollard, C., et al.[2020]

In a study of 21 patients with recurrent head and neck adenoid cystic carcinoma, personalized stereotactic ablative brachytherapy (SABT) showed an impressive objective response rate of 85.7% and a disease control rate of 100%, indicating its efficacy as a salvage treatment after previous therapies.

The treatment resulted in significant local control, with 3- and 5-year local control rates of 68.8% and 55.1%, respectively, and was generally safe, with most adverse events being mild and well-tolerated.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Chen, Y., Dai, J., Jiang, Y., et al.[2021]

Radiation therapy combined with surgery for patients with adenoid cystic carcinoma resulted in high local control rates, with 91% at five years and 81% at ten years, indicating its efficacy in managing this type of cancer.

However, distant metastases were a significant concern, with only 49% of patients free from them at ten years, and factors like T4 stage and nerve involvement were linked to poorer survival outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes and prognostic variables in adenoid cystic carcinoma of the head and neck: a recent experience. Gomez, DR., Hoppe, BS., Wolden, SL., et al.[2022]

In a study of 38 patients with sinonasal adenoid cystic carcinoma (SNACC) treated with particle beam radiation therapy (either proton beam therapy, carbon-ion radiotherapy, or a combination), the 3-year overall survival rate was an impressive 96.7%, indicating high efficacy of this treatment approach.

The treatment demonstrated a favorable safety profile, with no acute toxicities of grade 3 or above reported, suggesting that particle beam radiation therapy is a promising option for managing SNACC with satisfactory local control.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Particle Beam Radiation Therapy for Adenoid Cystic Carcinoma of the Nasal Cavity and Paranasal Sinuses. Hu, W., Hu, J., Huang, Q., et al.[2020]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiosurgery for locally advanced or recurrent skull base malignancies with prior external beam radiation therapy. [2020]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiosurgery (SABR) or Stereotactic body radiation therapy (SBRT). [2022]

3. England pubmed.ncbi.nlm.nih.gov

Undetected lymph node metastases in presumed early stage NSCLC SABR patients. [2017]

4. Germany pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy for small lung tumors with a moderate dose. Favorable results and low toxicity. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Serious complications associated with stereotactic ablative radiotherapy and strategies to mitigate the risk. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Incidence and risk factors for chest wall toxicity after risk-adapted stereotactic radiotherapy for early-stage lung cancer. [2022]

8. Singapore pubmed.ncbi.nlm.nih.gov

An optimal dose-fractionation for stereotactic body radiotherapy in peripherally, centrally and ultracentrally located early-stage non-small lung cancer. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Safety and Effectiveness of Stereotactic Ablative Radiotherapy for Ultra-Central Lung Lesions: A Systematic Review. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for adenoid cystic carcinoma metastatic to the lung: a case report. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

A Rare Case of Unresectable Adenoid Cystic Carcinoma of the Nasopharynx Treated with Intensity Modulated Proton Therapy. [2020]

12. Switzerland pubmed.ncbi.nlm.nih.gov

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 States pubmed.ncbi.nlm.nih.gov

Outcomes and prognostic variables in adenoid cystic carcinoma of the head and neck: a recent experience. [2022]

14. Switzerland pubmed.ncbi.nlm.nih.gov

Particle Beam Radiation Therapy for Adenoid Cystic Carcinoma of the Nasal Cavity and Paranasal Sinuses. [2020]