SBRT for Oligo-Progressive Cancer
(RADIANT Trial)
Trial Summary
What is the purpose of this trial?
Systemic therapy is the main treatment for patients with metastatic cancers. Oligo-progression has become a recognized entity for metastatic cancer and it is thought that a subset of cancer cells may develop heterogeneity and resistant clones while receiving systemic therapy. This results in overall tumor response but progression in metastatic sites. Current standard is to change systemic therapies. With advancing technologies, stereotactic body radiation therapy is being used to deliver high doses of focused radiation to the disease site, while minimizing risk of injury to the surrounding organs. SBRT is increasingly being used in patients presenting oligo-metastatic disease, and is recognized as having a potential for cure. This study will investigate the use of SBRT for breast and genito-urinary cancer patients with oligo-progression. Patients will be seen before and at the end of treatment and will be followed at 4 month intervals for up to 2 years. During the visits participants will complete quality of life questionnaires and will have standard of care imaging. Patients will also have the option to provide blood at baseline, during treatment, and at various follow up time points for analysis of ctDNA
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 data supports the effectiveness of the treatment Stereotactic Body Radiotherapy (SBRT) for oligo-progressive cancer?
Research suggests that SBRT can improve progression-free and overall survival in patients with oligometastatic non-small cell lung cancer. It is also shown to have high local control rates and low toxicity, potentially delaying the need for systemic therapy changes and improving quality of life.12345
Is Stereotactic Body Radiotherapy (SBRT) generally safe for humans?
Stereotactic Body Radiotherapy (SBRT), also known as Stereotactic Ablative Radiotherapy (SABR), is generally considered safe, but some serious complications have been reported. Studies have shown that while it is effective in controlling tumors, there are concerns about high-grade toxic effects, especially in certain types of cancer or tumor locations. Strategies to reduce these risks are important to ensure a favorable balance between benefits and potential side effects.678910
How is SBRT different from other treatments for oligo-progressive cancer?
SBRT (Stereotactic Body Radiotherapy) is unique because it delivers very precise, high doses of radiation directly to tumors while minimizing damage to nearby healthy tissues. This approach can effectively control tumor growth with low toxicity and may delay the need to change systemic therapies, potentially improving survival and quality of life for patients with oligo-progressive cancer.1451112
Eligibility Criteria
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive stereotactic body radiation therapy (SBRT) for oligo-progressive malignancies
Follow-up
Participants are monitored for safety and effectiveness after treatment, with follow-up visits every 4 months for up to 2 years
Treatment Details
Interventions
- Stereotactic Body Radiotherapy
Stereotactic Body Radiotherapy is already approved in European Union, United States, Canada, Japan for the following indications:
- Lung cancer
- Liver cancer
- Spine tumors
- Pancreatic cancer
- Prostate cancer
- Early-stage lung cancer
- Liver cancer
- Spine tumors
- Pancreatic cancer
- Prostate cancer
- Lung cancer
- Liver cancer
- Spine tumors
- Pancreatic cancer
- Prostate cancer
- Lung cancer
- Liver cancer
- Spine tumors
- Pancreatic cancer
- Prostate cancer
Find a Clinic Near You
Who Is Running the Clinical Trial?
University Health Network, Toronto
Lead Sponsor