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

Trial Summary

What is the purpose of this trial?

A multicenter randomized phase II trial of stereotactic body radiotherapy for oligo-progressive metastatic cancers. Eligible patients will be randomized in a 1:2 ratio between receiving their standard of care therapy or stereotactic ablative radiotherapy (SABR) to all sites of oligo-progressive lesions.Radiotherapy will be administered as soon as possible following randomization, and subjects will be followed until next disease progression. The primary outcome is progression-free survival (PFS).

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.

What data supports the effectiveness of this treatment for metastatic cancer?

Stereotactic Ablative Radiotherapy (SABR), also known as Stereotactic Body Radiation Therapy (SBRT), is effective in treating early-stage non-small cell lung cancer, offering high precision and large doses of radiation with good local control and low toxicity. This suggests it may also be beneficial for treating metastatic cancer, as it is used for metastases in various locations. ^{1 2 3 4 5}

How is SABR treatment different from other treatments for metastatic cancer?

Stereotactic Ablative Radiotherapy (SABR) is unique because it delivers high doses of radiation precisely to cancer cells, minimizing damage to surrounding healthy tissue. This precision makes it a promising option for patients with metastatic cancer, especially those with HIV, as it may reduce the risk of toxic effects compared to traditional radiotherapy. ^{6 7 8 9 10}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

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

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

2. Italy pubmed.ncbi.nlm.nih.gov

A multi-institutional analysis of fractionated versus single-fraction stereotactic body radiotherapy (SBRT) in the treatment of primary lung tumors: a comparison between two antipodal fractionations. [2021]

3. Switzerland 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. [2020]

4. Ireland pubmed.ncbi.nlm.nih.gov

Biological equivalent dose is associated with radiological toxicity after lung stereotactic ablative radiation therapy. [2023]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Patient-Reported Financial Burden Following Stereotactic Body Radiation Therapy for Localized Prostate Cancer. [2022]

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

Radiotherapy in patients with HIV: current issues and review of the literature. [2018]

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

The use of new antiretroviral therapy in combination with chemotherapy. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Autologous stem cell transplantation in HIV-related lymphoma in the rituximab era - a feasibility study in a monocentric cohort. [2018]

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

Factors Influencing Adherence to Antiretroviral Therapy among People Living with HIV in Coastal South India. [2018]

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

Safety and Tolerability of Carboplatin and Paclitaxel in Cancer Patients with HIV (AMC-078), an AIDS Malignancy Consortium (AMC) Study. [2022]