SBRT vs Standard Radiation for Cancer

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Anurag K. Singh

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Brain metastases, Pregnancy, Severe comorbidities, others

No Placebo Group

Prior Safety Data

Approved in 4 Jurisdictions

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}

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

Trial 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 (Radiation)
• Single-Fraction SBRT (Radiation Therapy)

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

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

The Cancer Institute at St. Francis Hospital East Hills, NY

Good Samaritan Hospital West Islip, NY

Roswell Park Cancer Institute Buffalo, NY

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute Lead Sponsor

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] Stereotactic ablative radiation therapy (SABR) delivered in a single fraction (SF) can be considered to have higher uncertainty given that the error probability is concentrated in a single session. This study aims to report the variation in technology and technique used and its effect on intrafraction motion based on a 10 years of experience in SF SABR.

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] Stereotactic ablative body radiotherapy (SABR) is widely used to treat inoperable stage 1 non-small-cell lung cancer (NSCLC), despite the absence of prospective evidence that this type of treatment improves local control or prolongs overall survival compared with standard radiotherapy. We aimed to compare the two treatment techniques.

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

Stereotactic ablative body radiotherapy (SABR) for bone only oligometastatic breast cancer: A prospective clinical trial. [2020] Stereotactic ablative body radiotherapy (SABR) is an emerging noninvasive approach for the treatment of oligometastases. Limited prospective evidence is available in breast cancer.

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

Delivery of magnetic resonance-guided single-fraction stereotactic lung radiotherapy. [2022] Single-fraction stereotactic ablative radiotherapy (SABR) is an effective treatment for early-stage lung cancer, but concerns remain about the accurate delivery of SABR in a single session. We evaluated the delivery of single-fraction lung SABR using magnetic resonance (MR)-guidance.

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

Stereotactic ablative radiotherapy (SABR) for non-small cell lung cancer. [2013] Stereotactic ablative radiotherapy (SABR), otherwise known as stereotactic body radiation therapy (SBRT), is an external beam treatment modality that offers the ability to deliver with high precision large doses of radiation over a limited number of fractions. SABR is currently a standard of care in the treatment of early-stage primary non-small cell lung cancers (NSCLCs) that are medically inoperable and for metastases in many anatomical locations. To date, local control and toxicity parameters with SABR for early-stage NSCLCs are comparable to those found in reports of experiences with surgical resection. It is increasingly apparent that some patients with borderline resectable lung primaries are also looking to SABR as a noninvasive means of therapy. However, randomized comparisons have not been completed to assess survival in operable patients. This review summarizes the advanced technology and radiation concepts that have helped clinicians optimize the use of stereotactic ablative therapies for lung cancer, with an emphasis on the rationale for future continued use of this advanced treatment modality.

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

Technical know-how in stereotactic ablative radiotherapy (SABR). [2022] Stereotactic ablative radiotherapy (SABR) is an addition to the armamentarium against cancer. The technical requirements for SABR are very stringent, given its very narrow therapeutic window. However, when the principles are strictly followed, it is possible to deliver SABR to extracranial tumours safely and effectively.

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

Stereotactic Ablative Body Radiation for Stage I Lung Cancer in Israel: A Retrospective Single-Center Report. [2022] Stereotactic ablative radiation therapy (SABR) is the application of a very high radiation dose to a small treatment volume. It is the new standard of care in medically inoperable early-stage lung cancer.

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

Biological equivalent dose is associated with radiological toxicity after lung stereotactic ablative radiation therapy. [2023] Stereotactic ablative radiation therapy (SABR) is the standard of care for inoperable early-stage non-small-cell lung cancer. Although the probability of grade ≥ II toxicities is low, many patients present radiological subclinical toxicities usually associated with long-term patient management challenges. We evaluated radiological changes and correlated them with the received Biological Equivalent Dose (BED).

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

Individualized Stereotactic Ablative Radiotherapy for Lung Tumors: The iSABR Phase 2 Nonrandomized Controlled Trial. [2023] Stereotactic ablative radiotherapy (SABR) is used for treating lung tumors but can cause toxic effects, including life-threatening damage to central structures. Retrospective data suggested that small tumors up to 10 cm3 in volume can be well controlled with a biologically effective dose less than 100 Gy.

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

Undetected lymph node metastases in presumed early stage NSCLC SABR patients. [2017] Stereotactic body radiation therapy (SBRT, also called stereotactic ablative body radiation SABR) is the treatment of choice for many patients with early-stage non-small cell lung cancer (NSCLC), including those who are unfit for surgery or refuse surgery.

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] Stereotactic body radiation therapy (SBRT) is a treatment option for patients with early-stage non-small cell lung cancer who are medically inoperable or decline surgery. Here we compare the outcome of patients with centrally located lung tumours who underwent either single fraction (SF)- or five-fraction (FF-) SBRT at a single institution over 5 years.

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

Stereotactic body radiation therapy for non-spine bone metastases--a review of the literature. [2022] Stereotactic body radiation therapy (SBRT) has the ability to deliver significantly higher biologically equivalent doses (BED) compared to conventional radiation treatment. The main goal of SBRT is to improve local tumor control while reducing pain. The side effects however may be greater than those of conventional treatment.

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

Stereotactic body radiation therapy (SBRT) for clinically localized prostate cancer: the Georgetown University experience. [2022] Stereotactic body radiation therapy (SBRT) delivers fewer high-dose fractions of radiation which may be radiobiologically favorable to conventional low-dose fractions commonly used for prostate cancer radiotherapy. We report our early experience using SBRT for localized prostate cancer.