IOeRT for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen byKyle Arneson

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Avera McKennan Hospital & University Health Center

No Placebo Group

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine if lumpectomy followed by Intraoperative Electron Radiation Therapy (IOeRT) as a single, full dose partial breast irradiation will have as good or better results in preventing recurrence of local breast cancer, cosmetic appearance and early and late side effects.

Research Team

Kyle Arneson

Principal Investigator

Avera Cancer Insitute

Eligibility Criteria

This trial is for post-menopausal women over 60 with a specific type of early-stage breast cancer that hasn't spread to lymph nodes. Candidates must have negative surgical margins, be BRCA1/2 negative, and agree to breast conservation therapy and sentinel lymph node biopsy. They should not have received prior chemotherapy for this cancer or have certain aggressive cancer features.

Inclusion Criteria

My breast cancer is a single, small tumor less than 2cm.

The edges of the removed tissue show no signs of cancer under a microscope.

I agree to have a sentinel lymph node biopsy to check my underarm area.

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Exclusion Criteria

My immune system is weakened.

I have had breast cancer or another cancer that has not spread and is not expected to shorten my life within 5 years.

My breast cancer has spread to my skin or chest wall.

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Treatment Details

Interventions

Single Fraction IOeRT (Radiation Therapy)

Trial OverviewThe study tests if a single dose of Intraoperative Electron Radiation Therapy (IOeRT) after lumpectomy can prevent the recurrence of local breast cancer effectively while maintaining cosmetic appearance and minimizing side effects compared to traditional treatments.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Single Fraction IOeRTExperimental Treatment1 Intervention

A single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered.