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Radiation Therapy

Pre-Operative Radiation Therapy for Breast Cancer (SPORT-DS Trial)

N/A

Waitlist Available

Research Sponsored by Michael Yassa

Eligibility Criteria Checklist

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

Must have

Tumors less than 2cm clinically on physical exam, as well as on breast ultrasound

World Health Organization (WHO) performance status 0-2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up in the 2 years after treatment

Awards & highlights

SPORT-DS Trial Summary

This trial will study whether giving a single dose of radiotherapy to low-risk breast tumours 3 months before surgery is effective.

Who is the study for?

This trial is for women aged 65 or older with low-risk breast cancer. Eligible participants have a small tumor (less than 2cm), no nodal disease, positive estrogen receptor status, negative Her2, and are planning partial mastectomy. Exclusions include prior cancers (except certain skin cancers), large tumors, lobular carcinoma only, positive lymph nodes, and serious non-cancer illnesses.Check my eligibility

What is being tested?

The study tests a single dose of preoperative partial radiotherapy given three months before surgery on patients with low-risk breast tumors. It aims to assess the effectiveness and safety of this approach compared to traditional treatment timelines.See study design

What are the potential side effects?

Potential side effects may include skin changes at the radiation site, fatigue, mild swelling or tenderness in the treated area. More serious but less common risks involve damage to nearby organs like the heart or lungs.

SPORT-DS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tumor is smaller than 2cm according to a physical exam and ultrasound.

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I can take care of myself and perform light activities.

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I am a woman aged 65 or older.

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I am scheduled for a partial mastectomy and sentinel lymph node biopsy.

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My biopsy shows my cancer is estrogen receptor positive.

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My biopsy shows I am HER2 negative.

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My biopsy results show low to moderate abnormality.

SPORT-DS Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ in the 2 years after treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~in the 2 years after treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and in the 2 years after treatment for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

rate of pathological complete response

Secondary outcome measures

incidence of radiation toxicity

SPORT-DS Trial Design

1Treatment groups

Experimental Treatment

Group I: Single Pre-Operative Radiation Therapy with Delayed SurgeryExperimental Treatment1 Intervention

Single Pre-Operative Radiation Therapy with Delayed Surgery

0 / 7Eligibility criteria met

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Who is running the clinical trial?

Michael YassaLead Sponsor

Frequently Asked Questions

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

Is enrollment for this clinical trial currently open?

"As outlined on clinicaltrials.gov, this research is not recruiting patients currently; the trial was initially posted April 1st 2018 and updated August 30th 2021. However, there are 2600 other trials seeking participants presently."

Answered by AI

What potential hazards should patients be aware of regarding Single Pre-Operative Radiation Therapy - with Delayed Surgery?

"Due to the limited evidence in its favour, Single Pre-Operative Radiation Therapy - with Delayed Surgery was assessed as a 1 on our safety scale. This rating reflects that this is an experimental stage one trial lacking significant proof of efficacy and security."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Single Pre-Operative Radiation Therapy - With Delayed Surgery for Low Risk Breast Cancer

Michael Yassa 2018. "Single Pre-Operative Radiation Therapy - With Delayed Surgery for Low Risk Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03917498.

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