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Radiation Therapy

Stereotactic Radiation for Breast Cancer

Phase 1
Waitlist Available
Led By Asal Rahimi, 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
Appropriate staging studies identifying as American Joint Committee on Cancer (AJCC) stage 0, I, or II breast cancer. If stage II, the tumor size must be 3 cm or less
Ductal carcinoma in situ (DCIS) or invasive epithelial (ductal, medullary, papillary, mucinous (colloid), or tubular histologies
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial is testing a new way to give radiation to people with pancreatic cancer.

Who is the study for?
This trial is for adults with early-stage breast cancer (stage 0, I, or II) who've had a lumpectomy with clear margins and no tumor larger than 3 cm. Participants must be disease-free from other cancers for at least a year, able to consent, not pregnant or breastfeeding, and willing to use contraception during the study.Check my eligibility
What is being tested?
The trial is testing how safe and effective Stereotactic Body Radiation Therapy (SBRT) is as a single fraction adjuvant treatment in patients who have undergone surgery for early-stage breast cancer.See study design
What are the potential side effects?
Potential side effects of stereotactic radiation may include skin changes like redness or irritation at the treatment site, fatigue, discomfort in the treated area, and rare risks associated with radiation exposure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My breast cancer is in an early stage (0, I, or II) and if stage II, my tumor is 3 cm or smaller.
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My breast cancer is non-invasive or invasive with specific types.
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I am 18 years old or older.
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I can take care of myself and am up and about more than 50% of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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
cosmesis
dose-limiting toxicity
Other outcome measures
Breast
distant disease-free interval
overall survival
+2 more

Side effects data

From 2019 Phase 1 & 2 trial • 160 Patients • NCT02052648
67%
Hypotension
67%
Nausea
67%
Constipation
67%
Cough
33%
Nocturia
33%
Abdominal pain
33%
Vision blurred
33%
Seizure
33%
Fatigue
33%
Traumatic haematoma
33%
Mood altered
33%
Pain in extremity
33%
Hyperchloraemia
33%
Micturition urgency
33%
Pollakiuria
33%
Urinary incontinence
33%
Pain
33%
Rectal haemorrhage
33%
Hypokalaemia
33%
Haemorrhoids
33%
Hyperglycaemia
33%
Decreased appetite
33%
Vomiting
33%
Proctitis
33%
Dyspnoea
33%
Sepsis
33%
Pyrexia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Phase 1 Dose Level 1
Phase 2 Cohort 2b
Phase 2 Cohort 2a
Phase 1 Dose Level 2
Phase 1 Dose Level 3
Phase 2 Cohort 2c

Trial Design

1Treatment groups
Experimental Treatment
Group I: Stereotactic RadiationExperimental Treatment1 Intervention
Single Fraction Stereotactic Radiation. Step No. Fractions Dose per fraction -1 1 20 0 (starting) 1 22.5 1 26.5 1 30
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Radiation
2014
Completed Phase 2
~170

Find a Location

Who is running the clinical trial?

University of Texas Southwestern Medical CenterLead Sponsor
1,047 Previous Clinical Trials
1,053,739 Total Patients Enrolled
22 Trials studying Breast Cancer
6,262 Patients Enrolled for Breast Cancer
Asal Rahimi, MDPrincipal InvestigatorUTSW Medical Center
7 Previous Clinical Trials
5,248 Total Patients Enrolled
4 Trials studying Breast Cancer
173 Patients Enrolled for Breast Cancer

Media Library

Stereotactic Radiation (Radiation Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT02685332 — Phase 1
Breast Cancer Research Study Groups: Stereotactic Radiation
Breast Cancer Clinical Trial 2023: Stereotactic Radiation Highlights & Side Effects. Trial Name: NCT02685332 — Phase 1
Stereotactic Radiation (Radiation Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02685332 — Phase 1

Frequently Asked Questions

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

Is this particular medical experimentopen for recruitment?

"According to clinicaltrials.gov, this trial is no longer recruiting new participants. Initially posted on March 31st 2016 and last modified 8/15/2022, the study has since concluded; however, there are still 2288 other medical studies actively seeking patients at present."

Answered by AI

To what extent might Stereotactic Radiation prove detrimental to a person's health?

"The data available for Stereotactic Radiation's safety was limited, so it earned a rating of 1."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Phase I Dose Escalation of Single Fraction Adjuvant Stereotactic Body Partial Breast Irradiation Early Stage Breast CA
Asal Rahimi 2016. "Phase I Dose Escalation of Single Fraction Adjuvant Stereotactic Body Partial Breast Irradiation Early Stage Breast CA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02685332.
~12 spots leftby Jun 2026
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