SBRT for Oligo-Progressive Cancer

(RADIANT Trial)

Overseen By Srinivas Raman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must be taking: ADT, Docetaxel

Disqualifiers: ≥6 metastases, Spinal cord compression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: Duration not specified

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to treat certain types of advanced breast and genito-urinary cancers when they resume growth despite ongoing treatment. It tests stereotactic body radiotherapy (SBRT), which uses precise, high-dose radiation to target and potentially eliminate resistant cancer spots while sparing healthy tissue. The trial seeks patients with five or fewer cancer sites treatable with this approach. Participants should have breast cancer or prostate, bladder, or kidney cancer that isn't spreading widely but is not fully responding to current treatments. Eligible patients will provide feedback on their quality of life and may give blood samples for additional analysis throughout the study. As an unphased trial, this study offers a unique opportunity to contribute to innovative cancer treatment research that could benefit future patients.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, it mentions that patients with oligo-progressive disease should have been receiving systemic therapy for at least 3 months, suggesting that continuing some treatments might be allowed.

What prior data suggests that Stereotactic Body Radiotherapy is safe for treating oligo-progressive cancer?

Research has shown that stereotactic body radiation therapy (SBRT) is generally safe for treating certain cancers with limited spread. Studies have found that SBRT effectively targets and destroys cancer cells while protecting nearby healthy tissue. This precision results in fewer side effects compared to traditional radiation.

In past studies, patients experienced mild to moderate side effects, such as tiredness or skin irritation, which are common with radiation treatments. Serious side effects were rare. These findings suggest that SBRT is well-tolerated and a viable option for treating cancers resistant to other treatments.

Prospective participants in a clinical trial for SBRT can be reassured that the therapy has been studied for its safety in humans. However, it is essential to discuss potential risks and benefits with a healthcare provider to determine if it is the right choice. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Stereotactic Body Radiotherapy (SBRT) for oligo-progressive cancer because it offers a highly precise way to target cancer cells with radiation. Unlike traditional radiation therapy, which can affect a larger area, SBRT delivers focused beams of radiation to just the tumor, minimizing damage to surrounding healthy tissue. This precision could lead to fewer side effects and potentially better outcomes. Additionally, SBRT is typically completed in fewer sessions, which is more convenient for patients and may improve their quality of life during treatment.

What evidence suggests that SBRT is effective for oligo-progressive cancer?

Research has shown that stereotactic body radiotherapy (SBRT) can effectively treat oligo-progressive cancer. SBRT targets specific tumor sites with high doses of focused radiation while protecting nearby healthy tissue. In this trial, participants with oligo-progressive genitourinary cancers and oligo-metastatic breast cancer will receive SBRT. Studies have found that SBRT can effectively stop the growth of targeted tumors. For patients with certain types of breast and genitourinary cancers, SBRT can delay the need to switch to other treatments. Overall, SBRT has been linked to fewer side effects compared to other treatments, making it a promising option for those dealing with specific metastatic cancer sites. ^{1 4 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults with certain types of cancer, like breast or genitourinary cancers, who have a small number (5 or less) of progressing tumors despite systemic therapy. Participants must be able to consent and have at least one tumor that can be treated with SBRT. They should not have had prior radiotherapy that overlaps with the treatment area or any conditions listed in the exclusion criteria.

Inclusion Criteria

My cancer has grown by at least 5 mm while on treatment, as shown on two scans 2-3 months apart.

My cancer is confirmed to be in the genitourinary tract.

My cancer has spread to 5 or fewer places in or outside my brain.

Exclusion Criteria

My cancer is not neuroendocrine, lymphoma, myeloma, or germ cell.

I do not have a current blockage in my intestines.

I cannot handle the physical setup needed for SBRT.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive stereotactic body radiation therapy (SBRT) for oligo-progressive malignancies

Duration not specified

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with follow-up visits every 4 months for up to 2 years

24 months

6 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Stereotactic Body Radiotherapy

Trial Overview The study is testing Stereotactic Body Radiotherapy (SBRT) on patients with oligo-progressive metastatic disease—meaning their cancer has spread but only a few areas are getting worse while on standard treatments. The goal is to see if high-dose radiation focused on these few areas can control the disease without harming nearby organs.

How Is the Trial Designed?

Group I: Oligo-metastatic Breast Cancer Experimental Treatment 1 Intervention

Receiving SBRT.

Group II: Oligo-Progression; GU Experimental Treatment 1 Intervention

Receiving SBRT.

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

Approved in European Union as Stereotactic Body Radiation Therapy for:

• Lung cancer
• Liver cancer
• Spine tumors
• Pancreatic cancer
• Prostate cancer

Approved in United States as Stereotactic Body Radiation Therapy for:

• Early-stage lung cancer
• Liver cancer
• Spine tumors
• Pancreatic cancer
• Prostate cancer

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Lung cancer
• Liver cancer
• Spine tumors
• Pancreatic cancer
• Prostate cancer

Approved in Japan as Stereotactic Body Radiation Therapy for:

• Lung cancer
• Liver cancer
• Spine tumors
• Pancreatic cancer
• Prostate cancer

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

Stereotactic ablative radiation therapy (SABR) for lung oligometastases shows promising safety and efficacy, with a 24-month overall survival rate of 74.6% and minimal toxicity, as only one significant adverse event was reported among 77 patients studied over an average follow-up of 22 months.

Colorectal metastases exhibited a notably higher local failure rate compared to other types of tumors, suggesting they may be more resistant to SABR, indicating a need for potential dose escalation strategies for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colorectal Histology Is Associated With an Increased Risk of Local Failure in Lung Metastases Treated With Stereotactic Ablative Radiation Therapy. Binkley, MS., Trakul, N., Jacobs, LR., et al.[2022]

The TROG 13.01/ALTG 13.001 clinical trial is investigating the safety and efficacy of single versus multi-fraction stereotactic ablative body radiotherapy (SABR) for lung tumors in 84 patients with up to three metastases, aiming to determine the best treatment approach for pulmonary oligometastases.

The study will compare a single high dose of 28Gy to a total of 48Gy delivered in four fractions, assessing not only safety but also quality of life, survival rates, and potential cost implications of each treatment method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomised phase II trial of Stereotactic Ablative Fractionated radiotherapy versus Radiosurgery for Oligometastatic Neoplasia to the lung (TROG 13.01 SAFRON II). Siva, S., Kron, T., Bressel, M., et al.[2022]

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]

In a study of 381 patients treated with stereotactic ablative body radiotherapy (SABR) for oligometastatic disease, the incidence of grade 3 or higher toxic effects was found to be less than 5%, indicating a favorable safety profile.

The rates of grade 2 or higher toxic effects were 18.6%, which is lower than the previously reported 29% in the SABR-COMET trial, suggesting that SABR may have acceptable toxicity levels and supports further research in larger trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment With Stereotactic Ablative Radiotherapy for Up to 5 Oligometastases in Patients With Cancer: Primary Toxic Effect Results of the Nonrandomized Phase 2 SABR-5 Clinical Trial. Olson, R., Jiang, W., Liu, M., et al.[2023]

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]

Stereotactic ablative radiotherapy (SABR) is a highly effective and low-toxicity treatment for metastatic tumors, achieving local control rates of about 80%.

SABR shows promise in treating oligometastatic patients, with pilot studies suggesting it may be 'curative' in 20-25% of cases, especially when combined with systemic therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New concepts and insights into the role of radiation therapy in extracranial metastatic disease. Ricardi, U., Filippi, AR., Franco, P.[2013]

In a study of 40 patients with central and ultracentral non-small cell lung cancer (NSCLC) treated with stereotactic ablative radiotherapy (SABR), those with ultracentral tumors experienced worse overall survival (OS) and progression-free survival (PFS) compared to those with central tumors, indicating a need for careful consideration in treatment planning.

The incidence of severe treatment-related toxicities (grade ≥3) was higher in the ultracentral group, with 12.5% of patients experiencing significant complications, including severe bronchial obstruction and esophageal perforation, highlighting the potential risks associated with SABR in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term outcomes in patients with central and ultracentral non-small cell lung cancer treated with stereotactic body radiotherapy: single-institution experience. Song, X., Zhao, L., Jiang, N., et al.[2023]

Stereotactic ablative radiotherapy (SABR) was found to be a safe and effective treatment for women with oligometastatic or progressive gynecological cancers, with a median progression-free survival (PFS) of 10.8 months based on a study of 28 patients and 47 lesions.

Favorable treatment responses were associated with smaller tumor sizes and higher biologically effective doses, indicating that careful patient selection and treatment planning can enhance the effectiveness of SABR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Outcomes for Stereotactic Ablative Radiotherapy in Oligometastatic and Oligoprogressive Gynecological Malignancies. Mesko, S., Sandler, K., Cohen, J., et al.[2018]

Stereotactic body radiation therapy (SBRT) demonstrated a high local control rate of 86.8% at one year and 76.3% at two years in treating oligometastatic disease in elderly patients, with a median age of 79 years and 82 patients involved in the study.

The treatment was found to be safe, with only 4.2% of patients experiencing Grade 2-3 toxicity and 5.9% experiencing Grade 1 toxicity, indicating that SBRT is a viable option for elderly patients, especially those who are fragile or prefer to avoid more invasive treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of stereotactic body radiation therapy (SBRT) in the treatment of oligometastatic disease in the elderly. Scorsetti, M., Clerici, E., Navarria, P., et al.[2018]

Stereotactic body radiation therapy (SBRT) is recommended as a safe and effective treatment for patients with oligometastatic non-small cell lung cancer, particularly when there are 3 or fewer metastatic deposits, based on a review of literature from 2008 to 2020.

The American Radium Society Lung Cancer Panel advises that consolidative radiation therapy should follow first-line systemic therapy rather than being administered upfront, and emphasizes the importance of individualized treatment plans due to limited data on certain clinical scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

American Radium Society Appropriate Use Criteria for Radiation Therapy in Oligometastatic or Oligoprogressive Non-Small Cell Lung Cancer. Amini, A., Verma, V., Simone, CB., et al.[2022]

Stereotactic body radiotherapy (SBRT) is effective in treating metastatic cancer, particularly in cases of oligometastatic disease and oligoprogression, where it targets progressing tumors while other tumors remain stable.

SBRT offers high local control rates with low toxicity, potentially delaying the need for systemic therapy and improving patients' progression-free survival and quality of life, although more prospective clinical trials are needed to confirm these benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiotherapy for oligoprogressive cancer. Cheung, P.[2018]

Stereotactic ablative body radiotherapy (SABR) is a feasible and well-tolerated treatment for patients with bone-only oligometastatic breast cancer, with 80% of patients successfully receiving treatment and no severe (grade 3 or 4) toxicities reported.

The treatment showed promising efficacy, with a 100% local progression-free survival (LPFS) and 67% distant progression-free survival (DPFS) at two years, suggesting that SABR could be a viable option for this patient group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. David, S., Tan, J., Savas, P., et al.[2020]

Citations

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Stereotactic Ablative Radiation for Oligoprogressive Cancers Secondary endpoints included overall survival (OS), lesional control, quality of life, adverse events, and duration of systemic therapy ...

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Stereotactic Body Radiation Therapy for Oligoprogressive ... Conclusion. SBRT is a safe and viable treatment option for oligoprogressive and oligorecurrent NSCLC. Patients with 0 to 2 sites had better OS and longer TNT-D ...