SABR for Metastatic Cancer

Recruiting at 6 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lawson Health Research Institute

Disqualifiers: Serious comorbidities, Prior radiotherapy, others

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

Compensation: Varies

Number of Visits: Unknown

90 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special type of radiation therapy called stereotactic ablative radiotherapy (SABR) for individuals with a specific type of lung cancer that has spread. The researchers aim to determine if SABR can delay cancer progression more effectively than usual treatments. Participants will either continue their current treatment or receive SABR to target new or growing cancer spots. Suitable candidates have lung cancer that has spread to no more than five spots and have been on the same treatment for at least six weeks. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options that could potentially enhance current care plans.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, it mentions that participants should have been on their current systemic therapy for at least 3 months before joining the trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that stereotactic ablative radiotherapy (SABR) is generally safe and well-tolerated for treating cancers that have spread. Studies have found that SABR rarely causes severe side effects. Most patients tolerate the treatment well, even with increased doses to enhance results. This method targets cancers that have spread to a few areas in the body. Overall, SABR is considered a safe option for managing these types of cancers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Stereotactic Ablative Radiotherapy (SABR) is unique because it precisely targets cancerous tumors with high-dose radiation, minimizing damage to surrounding healthy tissue. Unlike standard treatments like systemic therapies or observation, SABR offers a non-invasive approach that can treat multiple sites of cancer, even as they progress. Researchers are excited about SABR because it has the potential to extend the effectiveness of ongoing systemic treatments, offering patients a new way to manage metastatic cancer with fewer side effects.

What evidence suggests that this trial's treatments could be effective for metastatic cancer?

Studies have shown that Stereotactic Ablative Radiotherapy (SABR), one of the treatments in this trial, effectively treats cancers that have spread. One study found that SABR stopped cancer growth in nearly nine out of ten cases where cancer had spread to the spine. Another study noted that SABR improved symptoms in 86% of cases. Research also indicates that SABR can delay the need for additional treatments. For patients with five or fewer areas of cancer spread, SABR resulted in a one-year survival rate of 100%, compared to 50% for those with more than five areas. These findings suggest SABR could be a promising option for managing metastatic cancers. The trial also includes a Standard of Care Treatment arm, where treatment may involve continuing current systemic agents, observation, or switching to next-line treatment, at the discretion of the treating physicians. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

Adults with Non-Small Cell Lung Cancer (NSCLC) showing limited progression in up to 5 lesions, who've had a positive initial response or stable disease from recent systemic therapy. Not eligible if they have serious conditions like scleroderma, prior radiotherapy where treatment is needed, malignant pleural effusion, risk of spinal cord compression by the tumor, or can't treat all progressing sites.

Inclusion Criteria

Willing to provide informed consent

I am able to get out of my bed or chair and move around.

My cancer has spread to up to 5 spots without previous radiation.

Exclusion Criteria

My MRI shows a tumor near my spinal cord or compression of it.

I have had radiation therapy on the area that now needs treatment.

I have fluid buildup due to cancer in the lining of my lung.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Treatment

Participants are randomized to receive either standard of care therapy or stereotactic ablative radiotherapy (SABR) to all sites of oligo-progressive lesions

As soon as possible following randomization

Follow-up

Participants are monitored for progression-free survival and other outcomes until next disease progression

5 years

What Are the Treatments Tested in This Trial?

Interventions

• Standard of Care Treatment
• Stereotactic Ablative Radiotherapy (SABR)

Trial Overview The STOP Trial tests Stereotactic Ablative Radiotherapy (SABR) against standard cancer care for patients whose metastatic cancer has progressed only in a few areas. Participants are randomly chosen to receive either SABR or continue their current treatment and monitored for further disease progression.

How Is the Trial Designed?

Group I: Stereotactic Ablative Radiotherapy (SABR) Experimental Treatment 1 Intervention

SABR is delivered to all sites of progressive disease with continuation of current systemic agents. Further oligo-progressive lesions may be treated with SABR if possible. Upon progression at sites not amenable to SABR, the patient may receive any of the options in Arm 1.

Group II: Standard of Care Treatment Active Control 1 Intervention

Patient treatment may include the following 3 options, at the discretion of the treating physicians: * Continue with current systemic agent(s) * Observation * Switch to next-line treatment

Standard of Care Treatment is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Antiretroviral Therapy (ART) for:

• HIV/AIDS treatment
• Prevention of mother-to-child transmission of HIV

Approved in United States as Antiretroviral Therapy (ART) for:

• HIV/AIDS treatment
• Pre-exposure prophylaxis (PrEP)
• Post-exposure prophylaxis (PEP)

Approved in Canada as Antiretroviral Therapy (ART) for:

• HIV/AIDS treatment
• Prevention of mother-to-child transmission of HIV

Approved in Japan as Antiretroviral Therapy (ART) for:

• HIV/AIDS treatment

Approved in China as Antiretroviral Therapy (ART) for:

• HIV/AIDS treatment

Approved in Switzerland as Antiretroviral Therapy (ART) for:

• HIV/AIDS treatment

Who Is Running the Clinical Trial?

Lawson Health Research Institute

Lead Sponsor

Trials

684

Recruited

432,000+

London Health Sciences Centre Research Institute and Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

686

Recruited

427,000+

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

678

Recruited

421,000+

London Health Sciences Centre OR Lawson Research Institute of St. Joseph's

Lead Sponsor

Trials

668

Recruited

424,000+

Published Research Related to This Trial

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]

In a study of 100 patients with early-stage non-small cell lung cancer (NSCLC) treated with stereotactic ablative body radiotherapy (SABR), the 1-, 2-, and 3-year local control rates were 100%, 93.55%, and 84.33%, respectively, indicating high efficacy in tumor control.

The treatment was associated with low toxicity, with only 2% of patients experiencing Grade-3 side effects, suggesting that SABR is a safe option for patients who are inoperable or refuse surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Definitive Treatment of Early-Stage Non-Small Cell Lung Cancer with Stereotactic Ablative Body Radiotherapy in a Community Cancer Center Setting. Heal, C., Ding, W., Lamond, J., et al.[2020]

HIV infection can complicate cancer treatment due to immune system changes, but using combination antiretroviral therapy, especially protease inhibitors, can effectively suppress HIV replication and improve patient outcomes during chemotherapy.

Continuing antiretroviral therapy during chemotherapy is crucial, aiming for HIV RNA levels below 500 copies/mL, while adjustments to treatment may be necessary if side effects occur or if the viral load increases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of new antiretroviral therapy in combination with chemotherapy. Tan, B., Ratner, L.[2019]

In a study of 102 patients treated with stereotactic ablative radiation therapy (SABR) for early-stage non-small-cell lung cancer, a significant correlation was found between higher Biological Equivalent Doses (BED) over 300 Gy and the development of radiological changes such as organizing pneumonia and lung affectation over a 2-year follow-up.

Radiological changes were more pronounced in patients receiving BEDs greater than 300 Gy to healthy lung volumes of at least 30 cc, suggesting that these findings could inform future radiotherapy dose constraints to minimize pulmonary toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biological equivalent dose is associated with radiological toxicity after lung stereotactic ablative radiation therapy. Cases, C., Benegas, M., Sánchez, M., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5675484/

Stereotactic ablative body radiotherapy (SABR) for effective ... Five hundred spinal metastases were treated with a single fraction of 12.5 – 25 Gy resulting in 88% radiographic control, 86% improvement in symptoms, and no ...

2. ascopubs.org ascopubs.org/doi/10.1200/GO-25-00004

Metastasis-Directed Stereotactic Body Radiation Therapy ... Conclusion. SBRT is effective and safe for treating OM and OP solid cancers, prolonging FISST and potentially delaying systemic treatments, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10993982/

Clinical outcomes and efficacy of stereotactic body radiation ... Patients who were treated with SBRT who had ≤5 metastatic lesions at first recurrence had a superior 1 year OS of 100 vs50% for those with >5 lesions (Figure 2B) ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0936655524001092

Treatment Outcomes of Stereotactic Ablative Body ... This study reported SABR treatment outcomes for multisite OM and OP diseases originating from metastatic breast cancer · It showed modest local control and post- ...

5. redjournal.org redjournal.org/article/S0360-3016(25)06023-7/abstract

One-Year Follow-Up of the BONY-M Phase 2 Trial Clinical outcomes following stereotactic body radiation therapy (SBRT) for non-spinal bone metastases: A systematic review and meta-analysis.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7689573/

Safety and Survival Rates Associated With Ablative ... The findings of this study suggest that stereotactic ablative radiotherapy is generally safe and well tolerated in the oligometastatic setting.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2452109422002299

Efficacy and Safety of Stereotactic Body Radiation Therapy ... Conclusions. SBRT provided durable LC for pediatric and AYA patients with cancer with minimal severe toxicities. Dose escalation may result in improved LC for ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11171376/

Disease Control and Toxicity Outcomes after Stereotactic ... Stereotactic ablative radiation therapy (SABR) may improve tumor control. We report the outcomes with the use of SABR in our pediatric solid tumor population.

9. jamanetwork.com jamanetwork.com/journals/jamaoncology/fullarticle/2773455

Safety and Survival Rates Associated With Ablative ... The findings of this study suggest that stereotactic ablative radiotherapy is generally safe and well tolerated in the oligometastatic setting.