Shorter Radiation Treatment for Breast Cancer That Has Spread to Lymph Nodes

Sponsor: University of Colorado, Denver

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT02700386

Provider View

This study is exploring a shorter radiation treatment for breast cancer patients who have had surgery and have cancer cells in their lymph nodes. The goal is to see if a four-week radiation course is as effective as the traditional six-week course.

Patient Parameters

Program Overview

The study aims to find out if a shorter, four-week radiation treatment can effectively treat breast cancer that has spread to the lymph nodes, compared to the traditional six-week treatment. This shorter course has been shown to be safe and effective for treating breast cancer in the breast tissue alone, but it is now being tested for a larger area including the chest, armpit, and shoulder.

Description

Participants in this study will receive a shorter course of radiation treatment lasting about four weeks, instead of the usual six weeks. This shorter treatment is designed to be just as effective as the longer one. It has already been proven safe and effective for treating breast cancer in the breast tissue. However, since cancer cells were found in the lymph nodes, radiation will be directed to a larger area, including the chest, armpit, and shoulder, which hasn't been fully tested with this shorter dose yet.

Eligibility Criteria

Inclusion Criteria

  • Women aged 18 or older who have had surgery for breast cancer and have cancer in their lymph nodes.
  • Women who have had either a total mastectomy or a lumpectomy.
  • Acceptable procedures for checking lymph nodes include axillary node dissection or sentinel node biopsy.
  • Women with certain stages of breast cancer, including those who had chemotherapy or are under 50 years old.
  • Must have recovered from surgery with no signs of infection and be in good overall health.
  • Must start the study within 180 days after surgery or chemotherapy.
  • Must be able to understand and sign a consent form.

Exclusion Criteria

  • Women under 18 years old.
  • Pregnant women.
  • Men.
  • Women with certain advanced stages of breast cancer or who haven't had surgery.
  • Women with positive margins after surgery or no cancer in lymph nodes.
  • Women more than 180 days out from surgery or chemotherapy.
  • Patients with lymph node involvement not treatable by surgery.
  • Patients with cancer in both breasts or previous radiation to the chest.
  • Patients with distant cancer spread or life expectancy under 5 years.
  • Patients with certain autoimmune diseases or other serious health conditions.
  • Patients with psychiatric or addiction issues that prevent study participation.
  • Patients with another cancer diagnosis not disease-free for at least 5 years.

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