SBRT vs Standard Radiation for Cancer

Recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Brain metastases, Pregnancy, Severe comorbidities, others

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

Prior Safety Data This treatment has passed at least one previous human trial

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

Compensation: Varies

Number of Visits: 3

Duration: Up to 10 fractions

1500 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well single-fraction stereotactic body radiation therapy (SBRT) works when compared to standard radiation therapy in treating patients with cancer that has spread to other places in the body (metastatic). Stereotactic body radiation therapy uses special equipment to position a patient and deliver radiation to tumors with high precision. This method can kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Stereotactic Ablative Radiotherapy (SABR) for cancer?

Stereotactic Ablative Radiotherapy (SABR) is a precise radiation treatment that is effective for early-stage non-small cell lung cancer (NSCLC) and is considered a standard care option for inoperable cases, with local control and side effects similar to surgery. It is also being explored for use in other cancers, such as breast cancer with bone metastases, although more evidence is needed. ^{1 2 3 4 5}

Is Stereotactic Ablative Radiation Therapy (SABR) generally safe for humans?

Stereotactic Ablative Radiation Therapy (SABR) is generally considered safe for treating certain cancers, like early-stage lung cancer, but it can cause some side effects, including potential damage to nearby structures. The risk of serious side effects is low when the treatment is carefully planned and delivered. ^{1 6 7 8 9}

How is SBRT different from standard radiation treatment for cancer?

SBRT (Stereotactic Body Radiation Therapy) is unique because it delivers high doses of radiation in fewer sessions compared to standard radiation therapy, which typically involves lower doses over more sessions. This approach can be more effective in controlling tumors and is often used for patients who cannot undergo surgery. ^{3 10 11 12 13}

Research Team

Anurag K. Singh

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

This trial is for adults with confirmed metastatic cancer causing symptoms or likely to cause symptoms, where radiation could help. They must be able to follow the study plan and complete surveys. Pregnant women, those with brain metastases, recent severe heart issues, active severe infections, or prior radiation at the same site are excluded.

Inclusion Criteria

Participants of child-bearing potential must agree to use adequate contraceptive methods (e.g., hormonal or barrier method of birth control; abstinence) prior to study entry. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately

I have another cancer besides the one being treated, but it is under control or confirmed to be metastatic.

My cancer has been confirmed through lab tests.

Exclusion Criteria

I am under the age of 18.

I am scheduled for surgery to remove or stabilize cancer at the site planned for radiation.

Unwilling or unable to follow protocol requirements

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either single-fraction SBRT or multiple fractions of palliative radiation therapy

Up to 10 fractions

1-10 visits (in-person)

Follow-up

Participants are monitored for safety, quality of life, and pain response after treatment

12 weeks

2 visits (in-person)

Treatment Details

Interventions

• Palliative Radiation Therapy
• Single-Fraction SBRT

Trial Overview The trial compares single-fraction SBRT—a precise high-dose radiation therapy given in one session—to standard palliative radiation therapy over multiple sessions for patients with metastatic cancer. It aims to see which method better relieves symptoms while minimizing harm to healthy tissue.

Participant Groups

Group I: Arm II (SBRT) Experimental Treatment 3 Interventions

Patients undergo single fraction SBRT.

Group II: Arm I (palliative RT) Experimental Treatment 3 Interventions

Patients undergo 1, 3-5, 5-6, or 10 fractions of palliative RT deemed appropriate by the treating physician.

Single-Fraction SBRT is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Stereotactic Body Radiation Therapy for:

• Primary lung cancer
• Pancreatic cancer
• Liver tumors
• Kidney tumors
• Adrenal gland tumors
• Spine tumors
• Metastatic tumors

Approved in European Union as Stereotactic Body Radiation Therapy for:

• Primary lung cancer
• Pancreatic cancer
• Liver tumors
• Kidney tumors
• Adrenal gland tumors
• Spine tumors
• Metastatic tumors

Approved in Canada as Stereotactic Body Radiation Therapy for:

• Primary lung cancer
• Pancreatic cancer
• Liver tumors
• Kidney tumors
• Adrenal gland tumors
• Spine tumors
• Metastatic tumors

Approved in Japan as Stereotactic Body Radiation Therapy for:

• Primary lung cancer
• Pancreatic cancer
• Liver tumors
• Kidney tumors
• Adrenal gland tumors
• Spine tumors
• Metastatic tumors

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+

Findings from Research

Over a 10-year period, the use of single-fraction stereotactic ablative radiation therapy (SF SABR) increased, primarily for lung treatments, demonstrating its growing acceptance as an effective treatment option.

The average intrafraction motion during SF SABR was found to be 1.7 ± 1.6 mm, indicating that despite the higher uncertainty associated with single-session treatments, the motion was acceptable and supports the efficacy of this approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment Time Optimization in Single Fraction Stereotactic Ablative Radiation Therapy: A 10-Year Institutional Experience. Gaudreault, M., Yeo, A., Kron, T., et al.[2022]

In a multicenter phase 3 trial involving 101 patients with inoperable stage 1 non-small-cell lung cancer, stereotactic ablative body radiotherapy (SABR) demonstrated significantly better local control compared to standard radiotherapy, with a 68% reduction in the risk of local treatment failure (hazard ratio 0.32).

SABR was associated with a similar safety profile to standard radiotherapy, showing no increase in major toxicity, making it a preferred treatment option for patients with this type of lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy versus standard radiotherapy in stage 1 non-small-cell lung cancer (TROG 09.02 CHISEL): a phase 3, open-label, randomised controlled trial. Ball, D., Mai, GT., Vinod, S., et al.[2022]

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]

Single-fraction stereotactic ablative radiotherapy (SABR) for early-stage lung cancer can be delivered with high precision using magnetic resonance (MR) guidance, achieving a mean gross tumor volume coverage of 99.6%.

While most patients completed the treatment in a single session, the study highlighted the need for better tracking of small tumors and reducing overall treatment times, as the median procedure lasted 120 minutes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivery of magnetic resonance-guided single-fraction stereotactic lung radiotherapy. Finazzi, T., van Sörnsen de Koste, JR., Palacios, MA., 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) is a promising treatment option for extracranial tumors, demonstrating both safety and effectiveness when applied with strict adherence to technical guidelines.

The treatment has a very narrow therapeutic window, meaning precise delivery is crucial for maximizing its benefits while minimizing risks to surrounding healthy tissue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical know-how in stereotactic ablative radiotherapy (SABR). Lo, SS., Foote, M., Siva, S., et al.[2022]

Stereotactic ablative radiation therapy (SABR) for stage I lung cancer at Sheba Medical Center showed a median overall survival of 46 months and a 3-year survival rate of 59%, indicating its efficacy as a treatment for inoperable patients.

The treatment demonstrated excellent local control at 88% and had manageable toxicity, with only 8.4% of patients experiencing chest wall pain and a low incidence of severe side effects, suggesting it is a safe option for patients with early-stage lung cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Body Radiation for Stage I Lung Cancer in Israel: A Retrospective Single-Center Report. Appel, S., Lawrence, YR., Goldstein, J., et al.[2022]

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]

The iSABR trial demonstrated that individualized stereotactic ablative radiotherapy (SABR) for lung tumors resulted in high local control rates, with freedom from local recurrence at 1 year ranging from 94% to 97% across different patient groups.

The trial showed a low incidence of severe toxic effects (only 5%), indicating that personalized dosing strategies can minimize risks while maintaining effective treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individualized Stereotactic Ablative Radiotherapy for Lung Tumors: The iSABR Phase 2 Nonrandomized Controlled Trial. Gensheimer, MF., Gee, H., Shirato, H., et al.[2023]

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 patients with centrally located lung tumors, both single fraction (SF) and five-fraction (FF) stereotactic body radiation therapy (SBRT) showed comparable 1-year overall survival rates of 82% and 87%, respectively, indicating that both treatment options are effective.

There was no significant difference in severe toxicity (grade 3+) between the two groups, suggesting that SF-SBRT is a safe alternative for patients who cannot undergo multi-fraction treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of single- and five-fraction schedules of stereotactic body radiation therapy for central lung tumours: a single institution experience. Ma, SJ., Syed, YA., Rivers, CI., et al.[2022]

Stereotactic body radiation therapy (SBRT) shows high local control rates for non-spine bone metastases, with reported rates exceeding 85% in the studies reviewed, indicating its efficacy in managing tumors.

Grade 3 and 4 toxicities were rarely reported, suggesting that SBRT may have a favorable safety profile compared to conventional radiation treatments, although the variability in study endpoints complicates direct comparisons of outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for non-spine bone metastases--a review of the literature. Bedard, G., McDonald, R., Poon, I., et al.[2022]

Stereotactic body radiation therapy (SBRT) for localized prostate cancer showed a high two-year biochemical relapse-free survival rate of 99%, indicating its efficacy in controlling the disease.

The treatment was well tolerated, with low rates of gastrointestinal (1%) and genitourinary (31%) toxicities, and most patients who were sexually potent before treatment maintained their potency two years later.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy (SBRT) for clinically localized prostate cancer: the Georgetown University experience. Chen, LN., Suy, S., Uhm, S., et al.[2022]

References

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

Treatment Time Optimization in Single Fraction Stereotactic Ablative Radiation Therapy: A 10-Year Institutional Experience. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Stereotactic ablative radiotherapy versus standard radiotherapy in stage 1 non-small-cell lung cancer (TROG 09.02 CHISEL): a phase 3, open-label, randomised controlled trial. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Delivery of magnetic resonance-guided single-fraction stereotactic lung radiotherapy. [2022]

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

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

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

Technical know-how in stereotactic ablative radiotherapy (SABR). [2022]

7. Israel pubmed.ncbi.nlm.nih.gov

Stereotactic Ablative Body Radiation for Stage I Lung Cancer in Israel: A Retrospective Single-Center Report. [2022]

8. Ireland pubmed.ncbi.nlm.nih.gov

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

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

Individualized Stereotactic Ablative Radiotherapy for Lung Tumors: The iSABR Phase 2 Nonrandomized Controlled Trial. [2023]

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

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

11. England pubmed.ncbi.nlm.nih.gov

Comparison of single- and five-fraction schedules of stereotactic body radiation therapy for central lung tumours: a single institution experience. [2022]

12. China pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy for non-spine bone metastases--a review of the literature. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Stereotactic body radiation therapy (SBRT) for clinically localized prostate cancer: the Georgetown University experience. [2022]