Intraoperative Radiation Therapy for Breast Cancer

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen byJose Bazan, MD, MS

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Ohio State University Comprehensive Cancer Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This phase II trial studies the side effects of intraoperative electron beam radiotherapy boost and to see how well it works in treating patients with stage I-II breast cancer undergoing surgery with reconstruction. Giving a single dose of electron beam radiation to the tumor cavity during the breast surgery before reconstruction may be a better way to kill tumor cells and shrink tumors.

Research Team

Jose Bazan, MD, MS

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

This trial is for women with stage I-II breast cancer who are clinically node negative and have no distant metastases. They must not have had previous invasive breast cancers (except LCIS), be non-pregnant, non-lactating, and willing to use contraception during radiation therapy. Exclusions include prior chest radiotherapy, bilateral or multiple cancers not removable through one incision, active lupus or scleroderma, among others.

Inclusion Criteria

You have early stage breast cancer that has not spread to the lymph nodes.

Your doctor may recommend an ultrasound and biopsy of lymph nodes in your armpit before surgery if they think it's necessary.

You have been diagnosed with breast cancer by a pathologist.

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Exclusion Criteria

You can participate if you have had lobular breast carcinoma in situ (LCIS), but not if you have had any other type of breast cancer.

You have advanced stage breast cancer that has spread to nearby lymph nodes or other parts of the body.

You have two or more cancers that cannot be removed through one small incision.

See 10 more

Treatment Details

Interventions

Intraoperative Electron Beam Radiotherapy Boost (Radiation Therapy)

Trial OverviewThe trial tests intraoperative electron beam radiotherapy as a boost during surgery before reconstruction in patients with early-stage breast cancer. It aims to see if delivering this single dose of radiation directly to the tumor site is effective in killing remaining tumor cells and reducing the tumor size.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Treatment (IOERT boost)Experimental Treatment6 Interventions

Patients undergo standard of care lumpectomy and then undergo 1 fraction of IOERT boost to the lumpectomy cavity. Patients then undergo standard of care oncoplastic reconstruction and whole breast radiation therapy.