Phase III Study Comparing X-ray and Proton Beam Radiation Therapy in Breast Cancer Patients

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT04443413

Provider View

This clinical trial is comparing the side effects of two types of radiation therapy, x-ray and proton beam, in patients who have had breast cancer surgery. The study aims to find out which treatment has fewer complications.

Patient Parameters

Program Overview

This study is looking at two different types of radiation therapy to see which one causes fewer side effects in breast cancer patients who have had surgery. X-ray therapy uses high-energy rays to target cancer cells, while proton beam therapy uses a different type of high-energy beam. Researchers want to know which method is safer and more effective for patients.

Description

The main goal of this study is to compare the side effects of two radiation treatments over a 24-month period. One treatment involves 5 sessions of radiation, while the other involves 25 sessions.

Secondary goals include:

  • Checking for any immediate side effects within the first year after treatment.
  • Monitoring for any long-term side effects that appear or continue after the first year.
  • Evaluating how well the cancer is controlled over five years, including survival rates and disease progression.

The study will also look at:

  • Patients' quality of life through surveys.
  • Factors that might affect cosmetic outcomes or require additional surgery.
  • The cost and effectiveness of each treatment.
  • Comparing the use of x-ray therapy with proton therapy for different types of breast cancer treatment.
  • Assessing cosmetic results through patient feedback and expert reviews.

Participants will be randomly assigned to one of two groups:

Group 1: Patients will receive x-ray therapy in 25 sessions, with an optional 4 additional sessions, starting within 12 weeks after their last breast cancer surgery or chemotherapy.

Group 2: Patients will receive proton beam therapy in 5 sessions, with an optional 5 additional sessions, starting within 12 weeks after their last breast cancer surgery or chemotherapy.

After treatment, patients will have follow-up visits at 12 weeks, 6 months, 12 months, 24 months, 36 months, and 5 years.

Eligibility Criteria

Inclusion Criteria

  • Must be 18 years or older.
  • Must have a confirmed diagnosis of breast cancer.
  • Must have had breast-conserving surgery or mastectomy (reconstruction is allowed).
  • Must have specific stages of breast cancer (T1-T4c, N0-3, M0).
  • Must have a performance status score of 0 to 2, indicating good overall health.
  • Must be able to provide written informed consent.
  • Must need radiation therapy as part of their treatment plan.
  • If unsure about eligibility, consult the study's principal investigator.

Exclusion Criteria

  • Cannot have medical conditions that prevent safe radiation therapy.
  • Cannot have severe illnesses or conditions that would interfere with the study.
  • Cannot have uncontrolled illnesses like infections, heart failure, or psychiatric conditions.
  • Cannot have active lupus or scleroderma.
  • Cannot have had previous radiation to the same breast or chest area.
  • Cannot have cancer that has spread from another origin.
  • Cannot have recurrent breast cancer.
  • Cannot require radiation to both breasts.
  • Cannot have inflammatory breast cancer (cT4d).
  • Cannot be male.
  • Must be able to comply with study requirements.

Get This Program In Your Inbox

Receive detailed information about this treatment opportunity to review with your healthcare provider.