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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

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

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

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
~20
Stereotactic Body Radiation Therapy
2012
Completed Phase 2
~780

Find a Location

Who is running the clinical trial?

Roswell Park Cancer InstituteLead Sponsor
402 Previous Clinical Trials
29,307 Total Patients Enrolled
Anurag K SinghPrincipal InvestigatorRoswell Park Cancer Institute
5 Previous Clinical Trials
414 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Quality-of-Life Assessment a reliable predictor of patient safety and health outcomes?

"Since this is a phase 2 trial, there is some evidence of safety but not efficacy. Therefore, our team scores Quality-of-Life Assessment as a 2."

Answered by AI

Is there still room for new patients in this clinical trial?

"This research, which was initially published on November 18th 2019, is still recruiting patients according to information found on clinicaltrials.gov. The most recent update was made on May 2nd, 2022."

Answered by AI
~656 spots leftby Nov 2027