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Radiation Therapy

SBRT vs Standard Radiation for Cancer

Phase 2
Recruiting
Led By Anurag K Singh
Research Sponsored by Roswell Park Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Pathologically confirmed malignancy
Clinical or pathologic evidence of metastatic disease
Must not have
Severe, active co-morbidity defined as follows: Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months; Transmural myocardial infarction within the last 3 months; Acute bacterial or fungal infection requiring intravenous antibiotics at the time of registration; Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy at the time of registration
Individuals who are not yet adults (infants, children, teenagers)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial compares single-fraction SBRT to standard radiation therapy in treating metastatic cancer. SBRT uses special equipment to 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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects include skin reactions at the treatment site, fatigue, nausea, and temporary pain flare-ups. Long-term risks may involve damage to nearby organs or tissues depending on the area treated.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer has been confirmed through lab tests.
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My cancer has spread to other parts of my body.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I do not have severe heart issues, infections needing IV antibiotics, or serious lung problems currently.
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I am under the age of 18.
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I am scheduled for surgery to remove or stabilize cancer at the site planned for radiation.
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I have not had radiation on the same area where more is planned.
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I am currently pregnant or breastfeeding.
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I have brain metastases.
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I am unable to give consent for medical procedures.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Quality of life
Pain responses
Secondary study objectives
Overall survival
Other study objectives
Changes in immune markers
Cognitive function
Frailty Assessment
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Palliative Radiation Therapy
2015
Completed Phase 1
~80
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~790

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
412 Previous Clinical Trials
31,235 Total Patients Enrolled
Anurag K SinghPrincipal InvestigatorRoswell Park Cancer Institute
6 Previous Clinical Trials
426 Total Patients Enrolled

Media Library

Single-Fraction SBRT (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04068649 — Phase 2
Cancer Research Study Groups: Arm II (SBRT), Arm I (palliative RT)
Cancer Clinical Trial 2023: Single-Fraction SBRT Highlights & Side Effects. Trial Name: NCT04068649 — Phase 2
Single-Fraction SBRT (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04068649 — Phase 2
~547 spots leftby Nov 2027
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