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Oncoplastic Surgery + IORT for Breast Cancer

N/A

Recruiting

Led By Janie L Weng Grumley, MD

Research Sponsored by Saint John's Cancer Institute

Eligibility Criteria Checklist

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

Must have

Time from initial BCT should be ≥ 1 year

No evidence of metastatic disease (M0)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial will study whether giving radiation therapy during surgery (intraoperative radiotherapy or IORT) to people who have had radiation therapy for breast cancer in the past may improve how the surgery looks, decrease surgical complications, and improve survival.

Who is the study for?

This trial is for women over 50 with early-stage breast cancer who've had chest radiation before and now have a single tumor ≤3cm without spread to lymph nodes or distant organs. They must be at least one year past initial treatment, refuse mastectomy, and have enough skin distance from the tumor for safe radiation.Check my eligibility

What is being tested?

The study tests oncoplastic partial mastectomy combined with IORT in patients previously treated with radiation. It's a single-group trial focusing on how well this approach works and its impact on appearance, complications, recurrence rates, necessity of full mastectomy later, and survival outcomes.See study design

What are the potential side effects?

While specific side effects are not listed here, typical risks may include skin reactions like redness or burn-like symptoms near the treatment area, potential wound healing issues due to prior radiation exposure, and general surgical risks such as infection or bleeding.

Eligibility Criteria

Inclusion Criteria

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

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It has been at least a year since my initial breast-conserving therapy.

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My cancer has not spread to other parts of my body.

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I have had radiation therapy to my entire breast or chest wall before.

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My disease is in one spot and smaller than 3 cm.

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My cancer has not spread to my lymph nodes.

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I have chosen not to undergo a mastectomy.

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I am 50 years old or older.

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My breast cancer has returned and is confirmed by tissue analysis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

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

Cosmetic Outcomes as evaluated by clinician completion of the Harvard Breast Cosmesis Grading Scale

Cosmetic Outcomes as evaluated using BREAST-Q questionnaire as a measure of patient-reported ratings.

Cosmetic Outcomes as evaluated using the Harvard Breast Cosmesis Grading Scale as a measure of patient-reported ratings.

+1 more

Secondary outcome measures

Segmental Mastectomy

Effectiveness of partial mastectomy with IORT, measured by local recurrence.

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single-armExperimental Treatment2 Interventions

Intraoperative Radiotherapy (Xoft, 20 Gy single dose)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intraoperative Radiotherapy

2012

N/A

~250

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Saint John's Cancer InstituteLead Sponsor

25 Previous Clinical Trials

6,997 Total Patients Enrolled

Janie L Weng Grumley, MDPrincipal InvestigatorSaint John's Cancer Institute

Media Library

Oncoplastic partial mastectomy Clinical Trial Eligibility Overview. Trial Name: NCT05289466 — N/A

Intra-Operative Radiation Therapy Research Study Groups: Single-arm

Intra-Operative Radiation Therapy Clinical Trial 2023: Oncoplastic partial mastectomy Highlights & Side Effects. Trial Name: NCT05289466 — N/A

Oncoplastic partial mastectomy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05289466 — N/A

Frequently Asked Questions

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

Is registration for this clinical experiment still available?

"According to clinicaltrials.gov, this medical endeavour is still recruiting participants; the trial was first posted on December 16th 2021 and last refreshed on March 18th 2022."

Answered by AI

How many participants may take part in this investigation?

"Correct. The clinicaltrial.gov database provides proof that this medical study, which was first uploaded to the website on December 16th 2021, is actively recruiting participants. A total of 30 patients need to be acquired from a single site."

Answered by AI

What are the main goals of this medical experiment?

"Over the course of five years, this trial will be monitoring Cosmetic Outcomes as evaluated by clinician completion of the Harvard Breast Cosmesis Grading Scale for its primary endpoint. Secondary objectives include assessing partial mastectomy with IORT's Effectiveness in terms of distant recurrence (measured dichotomously), disease-specific survival, and overall survival."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation.

Janie Grumley 2021. "Oncoplastic Partial Mastectomy With Intraoperative Radiation Therapy (IORT) in Early Stage Breast Cancer Patients With Prior History of Chest Wall Radiation.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05289466.