1500 Participants Needed

SBRT vs Standard Radiation for Cancer

Recruiting at 2 trial locations
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Roswell Park Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

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.12345

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.16789

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.310111213

Research Team

Anurag Singh MD | Roswell Park ...

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.
See 4 more

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
See 9 more

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 OverviewThe 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
2Treatment groups
Experimental Treatment
Group I: Arm II (SBRT)Experimental Treatment3 Interventions
Patients undergo single fraction SBRT.
Group II: Arm I (palliative RT)Experimental Treatment3 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

Find a Clinic Near You

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

References

Treatment Time Optimization in Single Fraction Stereotactic Ablative Radiation Therapy: A 10-Year Institutional Experience. [2022]
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]
Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. [2020]
Delivery of magnetic resonance-guided single-fraction stereotactic lung radiotherapy. [2022]
Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. [2013]
Technical know-how in stereotactic ablative radiotherapy (SABR). [2022]
Stereotactic Ablative Body Radiation for Stage I Lung Cancer in Israel: A Retrospective Single-Center Report. [2022]
Biological equivalent dose is associated with radiological toxicity after lung stereotactic ablative radiation therapy. [2023]
Individualized Stereotactic Ablative Radiotherapy for Lung Tumors: The iSABR Phase 2 Nonrandomized Controlled Trial. [2023]
Undetected lymph node metastases in presumed early stage NSCLC SABR patients. [2017]
Comparison of single- and five-fraction schedules of stereotactic body radiation therapy for central lung tumours: a single institution experience. [2022]
Stereotactic body radiation therapy for non-spine bone metastases--a review of the literature. [2022]
Stereotactic body radiation therapy (SBRT) for clinically localized prostate cancer: the Georgetown University experience. [2022]