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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

Must not have

Subjects who have had radiotherapy to a target within 3 cm of the IVC tumor thrombus

Subjects with a history of pulmonary embolism is excluded

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation therapy close to my IVC tumor.

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I have never had a pulmonary embolism.

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I do not have a history of high blood pressure in the lungs.

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I do not have untreated brain metastases.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

Adverse events post surgery

Overall survival

Peri-operative morbidity

+6 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Stereotactic ablative radiation therapyExperimental Treatment1 Intervention

SABR

0 / 9Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor

1,079 Previous Clinical Trials

1,056,139 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.