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Radiation Therapy

Radiosurgery for Breast Cancer (RSU Trial)

Phase 1

Waitlist Available

Led By Rachel Blitzblau, MD PhD

Research Sponsored by Duke University

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 3 years

Awards & highlights

RSU Trial Summary

This trial will test how much radiation a person can safely receive before having breast surgery.

Eligible Conditions

Breast Cancer

RSU Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

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

Treatment Details

Study Objectives

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

Primary outcome measures

Maximum Tolerated Dose

Secondary outcome measures

Cosmetic Outcome

Local Control

Other outcome measures

Acquire Tissue

Magnetic Resonance Images(MRI)

Side effects data

From 2023 Phase 1 trial • 35 Patients • NCT00944528

81%

Fibrosis deep connective tissue

56%

Dermatitis radiation

50%

Breast pain

50%

Seroma

31%

Skin induration

25%

Skin ulceration

25%

Skin hyperpigmentation

19%

Breast atrophy

13%

Fatigue

13%

Superficial soft tissue fibrosis

13%

Skin and subcutaneous tissue disorders - Other

Telangiectasia

Hematoma

Pruritus

Chest pain -cardiac

Infections and infestations-Other

100%

80%

60%

40%

20%

Study treatment Arm

Single Dose Radiosurgery: Dose Level 3

Single Dose Radiosurgery: Dose Level 1

Single Dose Radiosurgery: Dose Level 2

RSU Trial Design

3Treatment groups

Experimental Treatment

Group I: Single dose radiosurgery: Dose Level 3Experimental Treatment1 Intervention

A single 21 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.

Group II: Single dose radiosurgery: Dose Level 2Experimental Treatment1 Intervention

A single 18 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.

Group III: Single dose radiosurgery: Dose Level 1Experimental Treatment1 Intervention

A single 15 Gy dose of radiation given in radiosurgery technique about 10 days before lumpectomy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiosurgery

2005

Completed Phase 2

~190

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Duke UniversityLead Sponsor

2,358 Previous Clinical Trials

3,420,034 Total Patients Enrolled

53 Trials studying Breast Cancer

9,916 Patients Enrolled for Breast Cancer

Rachel Blitzblau, MD PhDPrincipal InvestigatorDuke University Medical Center, Dept of Radiation Oncology

3 Previous Clinical Trials

82 Total Patients Enrolled

3 Trials studying Breast Cancer

82 Patients Enrolled for Breast Cancer

Media Library

Single Dose Partial Breast Radiotherapy (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00944528 — Phase 1

Frequently Asked Questions

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

Has the Federal Drug Administration (FDA) sanctioned Radiosurgery?

"Our team at Power rated Radiosurgery as a 1 on the safety scale, signifying that there is limited data to support both its effectiveness and security."

Answered by AI

Are there any vacancies in this trial for potential participants?

"Per clinicaltrials.gov, this research endeavor is not presently seeking participants as the trial was posted on January 1st 2010 and last updated eighteen days ago. However, there are currently 2,600 other studies searching for suitable enrollees."

Answered by AI