Study on Higher or Standard Daily Radiation Therapy for Early-Stage Breast Cancer After Surgery

Sponsor: Radiation Therapy Oncology Group

Sponsor score: 0

ClinicalTrials ID:NCT01349322

Provider View

This clinical trial is comparing two types of daily radiation therapy to see which is more effective for treating early-stage breast cancer that has been surgically removed. The study aims to find out if a higher daily dose of radiation is as effective as the standard daily dose.

Patient Parameters

Program Overview

The purpose of this study is to determine if a higher daily dose of radiation therapy, given over a shorter period, is as effective as the standard daily dose in treating early-stage breast cancer that has been removed by surgery. The trial will compare the effectiveness and side effects of both treatments, focusing on how well they control cancer and their impact on breast appearance and symptoms.

Description

This study is designed to compare two different radiation therapy approaches for patients with early-stage breast cancer who have had surgery to remove the cancer. The main goal is to see if a higher daily dose of radiation, given over a shorter time, is as effective in controlling cancer as the standard daily dose given over a longer period.

The study will also look at the side effects of both treatments, including any breast-related symptoms and changes in appearance. Researchers will assess the risk of heart-related side effects for patients with cancer on the left side of the chest. They will also evaluate the use of advanced radiation techniques to ensure the treatment is safe and effective.

Participants will be randomly assigned to one of two treatment groups. After completing the radiation therapy, they will have follow-up visits at 1 month, 6 months, and then annually to monitor their health and the treatment's effectiveness.

Eligibility Criteria

Inclusion Criteria

  • Women with a confirmed diagnosis of early-stage breast cancer that has been surgically removed.
  • Must meet specific criteria, such as being under 50 years old, having certain cancer characteristics, or having received prior chemotherapy.
  • Surgery must have been completed within 50 days before joining the study.
  • Must have had breast-conserving surgery with clear margins.
  • Must have had specific tests and imaging done before starting the study.
  • Must be 18 years or older.
  • Must have adequate blood counts and organ function.
  • Women of childbearing potential must have a negative pregnancy test and agree to use contraception during the study.
  • Must provide informed consent to participate.

Exclusion Criteria

  • Advanced stages of breast cancer or cancer that has spread to other parts of the body.
  • Previous or concurrent cancer treatments that do not align with the study's requirements.
  • Certain medical conditions that could interfere with the study or increase risks, such as severe heart or lung disease.
  • Pregnant or breastfeeding women, or those not willing to use contraception.
  • Men with breast cancer.
  • Previous radiation therapy to the breast or nearby areas that would overlap with the study treatment.

Locations

FACILITYZIPCITYSTATE
University of Alabama at Birmingham Cancer Center35233BirminghamAlabama
The Kirklin Clinic at Acton Road35243BirminghamAlabama
21st Century Oncology-Scottsdale85251ScottsdaleArizona
Mayo Clinic in Arizona85259ScottsdaleArizona
Arizona Oncology Associates-West Orange Grove85704TucsonArizona
Banner University Medical Center - Tucson85719TucsonArizona
CHI Saint Vincent Cancer Center Hot Springs71913Hot SpringsArkansas
University of Arkansas for Medical Sciences72205Little RockArkansas
Sutter Cancer Centers Radiation Oncology Services-Auburn95603AuburnCalifornia
Sutter Cancer Centers Radiation Oncology Services-Cameron Park95682Cameron ParkCalifornia

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