Study on Shorter vs. Longer Proton Radiation Therapy for Breast Cancer

Sponsor: Proton Collaborative Group

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT05856773

Provider View

This clinical trial is comparing the effects of a shorter 3-week course of proton radiation therapy to the standard 5-week course for women with breast cancer who need radiation to the breast/chest wall and nearby lymph nodes.

Patient Parameters

Program Overview

The aim of this study is to find out if using proton radiation therapy over a shorter period (3 weeks) is as effective and safe as the traditional longer period (5 weeks) for women with breast cancer. The focus is on treating the breast or chest wall and the regional lymph nodes, which are areas where cancer might spread. Researchers want to see if the shorter treatment causes similar skin and tissue side effects compared to the longer treatment.

Description

This study is investigating whether a shorter course of proton radiation therapy, which involves fewer treatment days, is as effective as the standard longer course for treating breast cancer. The treatment targets the breast or chest wall and the regional lymph nodes, which are areas where cancer might spread. The goal is to see if the shorter treatment causes similar rates of skin and soft tissue side effects as the longer treatment. Proton therapy is a type of radiation that can precisely target cancer cells, potentially reducing damage to surrounding healthy tissue.

Eligibility Criteria

Inclusion Criteria

  • Women with Stage I-III breast cancer who have had surgery and are recommended to receive radiation therapy to the breast or chest wall and nearby lymph nodes.
  • Confirmed diagnosis of breast cancer that requires radiation to the breast/chest wall and regional lymph nodes.
  • No signs of cancer spread to other parts of the body based on specific scans.
  • Recent medical check-up within 90 days before joining the study.
  • Good overall health with a performance status score of 0, 1, or 2.
  • Negative pregnancy test for women who can have children.
  • Able to start radiation within 12 weeks after surgery or chemotherapy.
  • Breast implants or reconstruction are allowed.
  • If both breasts have cancer, at least one side must receive the comprehensive nodal irradiation as per the study protocol.

Exclusion Criteria

  • Advanced breast cancer with skin ulceration, satellite nodules, or swelling, or inflammatory breast cancer.
  • Remaining cancer detected by imaging or exam, except for small lymph nodes that can be treated with additional radiation.
  • Previous radiation therapy that overlaps with the current treatment area.
  • Previous removal of breast implants due to infection or healing issues without replacement.
  • Double port tissue expanders.
  • Evidence of cancer spread to distant parts of the body.
  • Pregnant or breastfeeding women.
  • Other serious health conditions that would prevent study treatment or follow-up.
  • History of connective tissue disorders like lupus or scleroderma.
  • Known BRCA 1 or BRCA 2 genetic mutation.
  • Active skin rash.
  • History of other invasive cancers unless disease-free for 3 years, except for certain non-threatening cancers.

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