Study on Using Electron Beam Radiation During Surgery for Stage I-II Breast Cancer with Reconstruction

Sponsor: Ohio State University Comprehensive Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02927912

Provider View

This clinical trial is exploring the use of a single dose of electron beam radiation during breast cancer surgery to see if it can effectively target and reduce tumors in patients with stage I-II breast cancer undergoing reconstruction.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the side effects and effectiveness of using a single dose of electron beam radiation during breast cancer surgery for patients with stage I-II breast cancer who are also having breast reconstruction. This approach aims to target the tumor area more precisely during surgery, potentially improving the treatment outcome by killing more cancer cells and reducing tumor size.

Description

The main goal of this study is to find out how often patients experience significant breast tissue hardening (grade 3 fibrosis) one year after receiving a single dose of electron beam radiation during surgery, followed by standard whole breast radiation.

Secondary goals include:

  • Checking the rate of cancer returning in the same breast over five years.
  • Assessing changes in patients' self-reported cosmetic outcomes using a specific questionnaire.
  • Evaluating doctors' assessments of cosmetic results using a standard scale and photographs.

Study Process:

  • Patients will have a standard lumpectomy (breast-conserving surgery) and receive a single dose of electron beam radiation directly to the surgery area.
  • After surgery, patients will undergo breast reconstruction and receive whole breast radiation therapy as part of standard care.
  • Follow-up visits will occur at 1 month, 6 months, 1 year, and annually for up to 5 years to monitor outcomes.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with stage I or II breast cancer with no cancer spread to lymph nodes.
  • No signs of cancer spread to other parts of the body based on medical exams.
  • Recent mammograms of both breasts within 90 days of diagnosis.
  • Adequate blood cell counts and hemoglobin levels.
  • Women of childbearing age must have a negative pregnancy test and agree to use contraception during radiation therapy.
  • Must provide informed consent to participate in the study.

Exclusion Criteria

  • Advanced breast cancer (stage III or IV) or cancer that has spread to other parts of the body.
  • History of other invasive cancers unless disease-free for at least 3 years.
  • Previous breast cancer or certain types of breast conditions.
  • Multiple tumors that cannot be removed with a single surgery.
  • Cancer in both breasts.
  • Certain types of breast cancer like ductal carcinoma in situ (DCIS) only.
  • Non-breast cancers like sarcoma or lymphoma.
  • Male breast cancer.
  • Paget's disease of the nipple.
  • Previous radiation therapy to the breast or nearby areas.
  • Pregnant women or those not willing to use contraception.
  • Certain autoimmune diseases or other medical conditions that prevent participation.

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