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Radiation
SABR for Renal Cell Carcinoma
Phase 2
Waitlist Available
Led By Raquibul Hannan, MD, PhD
Research Sponsored by University of Texas Southwestern Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
A female of child-bearing potential is any woman who has not undergone a hysterectomy or bilateral oophorectomy, or has not been naturally postmenopausal for at least 12 consecutive months
ECOG 0-2; or KPS > 60
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 years
Awards & highlights
Study Summary
This trial is testing whether using SAbR to target oligo-progressive mRCC can help patients by delaying the need to change their systemic therapy and improve PFS.
Who is the study for?
This trial is for adults with metastatic kidney cancer who are responding to current systemic therapy but have limited progression in up to three sites. They must be on their first to fourth line of FDA-approved systemic therapy, willing to use contraception, and able to give informed consent.Check my eligibility
What is being tested?
The study tests if Stereotactic Ablative Body Radiation (SAbR) can delay the need for changing effective systemic therapies by targeting a few progressing cancer spots in patients with oligoprogressive renal cell carcinoma.See study design
What are the potential side effects?
Potential side effects include those related to radiation such as localized skin reactions, fatigue, possible damage or irritation to surrounding tissues and organs near the treated area, and general discomfort.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman who could still become pregnant.
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I am mostly self-sufficient and can carry out daily activities.
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I am currently undergoing my 1st to 4th round of systemic therapy.
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My kidney cancer is confirmed and has spread to other parts.
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My kidney cancer responds to treatment, confirmed by scans.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to change of systemic therapy
Secondary outcome measures
Health-related quality of life (HRQOL)
Local control
Number of participants with adverse events
+4 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Stereotactic ablative body radiation (SABR)Experimental Treatment1 Intervention
SAbR will be used to treat all sites of measurable metastases. New sites of metastasis will be treated if deemed appropriate by both medical and radiation oncologists with SAbR.
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Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,779 Total Patients Enrolled
Raquibul Hannan, MD, PhDPrincipal InvestigatorUniversity of Texas
5 Previous Clinical Trials
96 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a woman who could still become pregnant.I am mostly self-sufficient and can carry out daily activities.I am currently undergoing my 1st to 4th round of systemic therapy.I want to keep receiving treatment for my condition.My kidney cancer is confirmed and has spread to other parts.My kidney cancer responds to treatment, confirmed by scans.I am on medication for cancer, and scans show limited spread to 3 or fewer places.I agree to use effective birth control during and for 90 days after the study.I have received FDA-approved treatments for kidney cancer.Your current treatment is okay with your doctor.I have 3 or more risk factors for kidney cancer as per IMDC criteria.I have had or currently have brain metastasis.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Stereotactic ablative body radiation (SABR)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has Stereotactic ablative body radiation (SABR) been granted regulatory approval?
"Based on our analysis, SABR is rated a 2 out of 3 for safety due to the findings from Phase 2 clinical trials. Although there's evidence that it can be safe, efficacy still needs to be confirmed."
Answered by AI
Are there any vacancies left for participants in this research project?
"The information on clinicaltrials.gov proclaims that this particular trial has ceased its recruitment of patients, with the initial announcement being made in October 2018 and a last-minute update issued at the end of August 2022. Despite this, 354 other studies remain actively seeking candidates for enrolment."
Answered by AI
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