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Radiation

Partial Breast Irradiation for Recurrent Breast Cancer

Q: Is this research project recruiting participants presently?

<p>This medical study, which was made available to the public on November 22nd 2023 and last updated two weeks ago, is not currently looking for participants. However, there are 2761 other trials that do have open recruitment slots at this time.</p>

Q: Has the FDA given its approval for Radiation Therapy (RT) to be used?

<p>Based on our analysis, radiation therapy was given a rating of 2 due to the preliminary data that supports its safety but lacks any evidence for efficacy.</p>

Phase 2

Recruiting

Led By Janice Lyons, MD

Research Sponsored by Case Comprehensive Cancer Center

Eligibility Criteria Checklist

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

Must have

Negative resection margins with at least a no tumor on ink from invasive and 2 mm margins for ductal carcinoma in-situ or a negative re-excision

Participants' recurrences must have histologically confirmed ductal carcinoma in-situ, invasive ductal, medullary, papillary, colloid (mucinous), or tubular histologies

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

Study Summary

This trial will compare giving radiation once a day or twice a day for breast cancer that has returned after surgery.

Who is the study for?

This trial is for adults over 18 with a specific breast cancer recurrence that's small (<3cm), treated surgically without spread to lymph nodes or distant organs. Participants must be in good health, understand the study, and consent to join. It excludes those with certain other breast cancers, genetic mutations like BRCA, systemic diseases affecting skin/connective tissue, pregnant/lactating women, and anyone unable to consent.Check my eligibility

What is being tested?

The study tests if radiation therapy once daily for 15 treatments after repeat surgery is as effective as the standard twice-daily radiation for 30 treatments. The goal is to see if fewer sessions can still prevent cancer from returning while potentially reducing inconvenience and side effects.See study design

What are the potential side effects?

Radiation therapy may cause skin irritation at the treatment site, fatigue, mild swelling or tenderness of the breast area involved. Rarely it might lead to more serious issues such as changes in skin texture or secondary cancers.

Eligibility Criteria

Inclusion Criteria

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

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My surgery removed all visible cancer with clear margins.

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My breast cancer recurrence is of a specific type, confirmed by a biopsy.

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I can take care of myself but might not be able to do heavy physical work.

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I am older than 18 years.

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My breast cancer has come back in one spot only.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 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

Treatment-related adverse events as graded by CTCAE criteria

Secondary outcome measures

Evaluation of Cosmesis

In-breast tumor recurrence rate

Mastectomy-free survival rate

+3 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Radiation Therapy(RT)Experimental Treatment1 Intervention

There will be one treatment cohort. Radiation therapy will be delivered daily for 15 daily fractions, 2.67Gy per fraction, delivered using a 3-D or IMRT(Intensity Modulate Radiation Therapy) plan. For participants with high-risk features deemed by the radiation oncologist who would otherwise be a candidate for a boost (age <50, high grade, poor biology, close margins), 48 Gy delivered in fifteen fractions of 3.2 Gy is allowed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Radiation Therapy

2017

Completed Phase 3

~7250

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Case Comprehensive Cancer CenterLead Sponsor

453 Previous Clinical Trials

31,875 Total Patients Enrolled

Janice Lyons, MDPrincipal InvestigatorUniversity Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

3 Previous Clinical Trials

86 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 this research project recruiting participants presently?

"This medical study, which was made available to the public on November 22nd 2023 and last updated two weeks ago, is not currently looking for participants. However, there are 2761 other trials that do have open recruitment slots at this time."

Answered by AI

Has the FDA given its approval for Radiation Therapy (RT) to be used?

"Based on our analysis, radiation therapy was given a rating of 2 due to the preliminary data that supports its safety but lacks any evidence for efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation in Ipsilateral Breast

2023. "Repeat Breast Conserving Surgery Followed by Daily Partial Breast Irradiation in Ipsilateral Breast". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06129747.