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Radiation Therapy
SABR for Kidney Cancer
Phase 1 & 2
Waitlist Available
Led By Raquibul Hannan, MD
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
Tumor thrombus must be ≥ level II (As per Mayo classification)
Performance status ECOG 0-2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 years
Awards & highlights
Study Summary
This trial is testing whether a specific type of cancer treatment is safe and effective for treating tumors in the IVC.
Who is the study for?
This trial is for adults with kidney cancer that has spread to the large vein (IVC) carrying blood from the lower body to the heart. Participants must be able to have an MRI or CT scan, be in fair health (ECOG 0-2), and use birth control if needed. They should agree to surgery after radiation therapy and can join even with treated metastases elsewhere.Check my eligibility
What is being tested?
The study tests pre-operative Stereotactic Ablative Radiation Therapy (SABR) on IVC tumor thrombus in kidney cancer patients. It aims to assess safety, feasibility, and whether this treatment before surgery can help patients remain free of cancer one year post-treatment.See study design
What are the potential side effects?
Potential side effects may include skin reactions at the treatment site, fatigue, nausea, changes in blood counts leading to increased infection risk or bleeding problems, and possible damage to nearby organs like intestines or liver.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My cancer has a significant blood clot in a vein according to the Mayo classification.
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I am able to get out of my bed or chair and move around.
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My kidney cancer has spread to the large vein leading to my heart.
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I am 18 years old or older.
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All my cancer spread areas have been treated with surgery or targeted radiation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Survival at one year
To determine the feasibility of neoadjuvant SABR followed immediately by IVC tumor thrombectomy
To determine the operative safety of neoadjuvant SABR followed immediately by IVC tumor thrombectomy
Secondary outcome measures
Adverse events post surgery
Overall survival
Peri-operative morbidity
+6 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Stereotactic ablative radiation therapyExperimental Treatment1 Intervention
SABR
Find a Location
Who is running the clinical trial?
University of Texas Southwestern Medical CenterLead Sponsor
1,045 Previous Clinical Trials
1,053,649 Total Patients Enrolled
Raquibul Hannan, MD3.03 ReviewsPrincipal Investigator - UTSW
University of Texas Southwestern Medical Center
1 Previous Clinical Trials
60 Total Patients Enrolled
1Patient Review
In 2014, I received treatment from Dr. Hannah for prostate cancer. In 2017, I started to experience blood in my urine. This condition worsened and I was diagnosed with radiation cystitis of the bladder. I have been treated twice now with 45 days each in a hyperbaric chamber. This lasts for a few months and now I am looking at major surgery to remove the bladder. I don’t believe that Dr. Hannah did an adequate job of overseeing my radiation treatment.
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had radiation therapy close to my IVC tumor.My albumin level is at least 3.4 g/dL or higher.I agree to use birth control during the study.My cancer has a significant blood clot in a vein according to the Mayo classification.I can have surgery and SABR even if I've had other experimental treatments.I am able to get out of my bed or chair and move around.My kidney cancer has spread to the large vein leading to my heart.I have never had a pulmonary embolism.You need to be able to have an MRI or CT scan.I do not have a history of high blood pressure in the lungs.Your AST blood test should ideally be less than or equal to 34 IU/L, but slightly higher levels may be allowed.I do not have untreated brain metastases.My urologist has approved me for a specific surgery to remove a tumor from a large vein.My cancer has spread to other parts of my body.I am 18 years old or older.My doctor has approved me for a specific radiation therapy for my tumor.All my cancer spread areas have been treated with surgery or targeted radiation.If the level of a specific protein in your blood is less than 3.4, it might increase the chance of problems after surgery.
Research Study Groups:
This trial has the following groups:- Group 1: Stereotactic ablative radiation therapy
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.
Is there still capacity for individuals to join this clinical trial?
"Affirmative, clinicaltrials.gov divulges that the medical research is currently recruiting participants. Originally listed on June 1st 2015 and recently updated on July 11th 2022, this trial seeks 29 volunteers across a single site."
Answered by AI
What are the key goals that this trial is aiming to accomplish?
"In this 90-day clinical trial, the primary objective is to establish the operative safety of neoadjuvant SABR followed immediately by IVC tumor thrombectomy. Secondary objectives are assessing recurrence free survival after one year, rate of pulmonary emboli within a 12 month period, and systemic metastasis rates. Pulmonary Embolus will be determined if patients display symptoms along with radiographic evidence on CT angio or V/Q scan; whereas Systemic Metastasis requires any evidence that progresses over 6 weeks on repeated scans."
Answered by AI
How many participants have registered for this experiment?
"Affirmative. According to records on clinicaltrials.gov, this medical study is currently enlisting patients; it was initially published in June 2015 and most recently updated in July 2022. 29 participants are needed at a single site for the trial's completion."
Answered by AI
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