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Procedure

Stereotactic Body Radiation Therapy (SBRT) for Renal Cell Carcinoma

Phase 1 & 2

Waitlist Available

Led By Michael Bassetti

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up until 30 days after ablation (up to 12 weeks on study)

Awards & highlights

Study Summary

This trial is testing a new way to treat cancer with a combination of MRI-guided radiation and microwave ablation. They want to know if it's safe and effective.

Eligible Conditions

Renal Cell Carcinoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ until 30 days after ablation (up to 12 weeks on study)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~until 30 days after ablation (up to 12 weeks on study)

This trial's timeline: 3 weeks for screening, Varies for treatment, and until 30 days after ablation (up to 12 weeks on study) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Dose-limiting Toxicity With SBRT Combined With Microwave Ablation for Renal Cell Carcinoma

Secondary outcome measures

Local Control Rate Per RECIST Criteria as Reported by Count of Participants

Overall Survival

Progression Free Survival

+1 more

Other outcome measures

Tumor Pathology of Post-SBRT Specimen (Pathologic Evaluation)

Side effects data

From 2018 Phase 2 trial • 35 Patients • NCT01360593

21%

Anemia

18%

Neutropenia

15%

Hypoalbuminemia

15%

White blood cell decreased ( leukopenia)

15%

Diarrhea

12%

Liver Dysfunction

Hand-Foot

Bleeding

Stroke

Abdominal Infection

Ileus

Mucositis

Edema

Dermatitis

Platelet count decreased ( Thrombocytopenia)

100%

80%

60%

40%

20%

Study treatment Arm

Gem + Xeloda + SBRT

Trial Design

1Treatment groups

Experimental Treatment

Group I: Radiotherapy & Microwave AblationExperimental Treatment2 Interventions

3+3 dose-escalation wherein three dose levels of stereotactic body radiation therapy (SBRT) would be evaluated: Dose level I: 6 Gy x 5 fractions Dose level II: 8 Gy x 5 fractions Dose level III: 10 Gy x 5 fractions Radiation treatments will be delivered two to three times a week, with five fractions completed over two weeks. Four to six weeks after radiation treatment, patients will undergo repeat CT or MRI imaging to assess tumor response and suitability for microwave ablations. Eight weeks after the conclusion of SBRT, patients will undergo microwave ablation (approximately 12 weeks after registration).

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Stereotactic Body Radiation Therapy (SBRT)

2018

Completed Phase 2

~740

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor

1,189 Previous Clinical Trials

3,169,543 Total Patients Enrolled

Michael BassettiPrincipal InvestigatorUniversity of Wisconsin, Madison

1 Previous Clinical Trials

21 Total Patients Enrolled

Frequently Asked Questions

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

Is it possible to join the current clinical trial?

"According to the clinicaltrials.gov registry, this research endeavour is recruiting candidates as of now. It was initially publicised on June 28th 2018 and its details were most recently amended on December 20th 2021."

Answered by AI

What is the full scope of participants involved in this research project?

"Affirmative. According to clinicaltrials.gov, this medical research is currently recruiting individuals for participation; the trial was initially posted on June 28th 2018 and most recently updated on December 20th 2021. The study requires a total of 28 patients from one site only."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Microwave Ablation With MRI-Guided SBRT Boost in Renal Cell Carcinoma

2018. "Microwave Ablation With MRI-Guided SBRT Boost in Renal Cell Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02782715.