Ultrahypofractionation and Normal Tissue Toxicity

Launched by MASSACHUSETTS GENERAL HOSPITAL · Jun 12, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating whether a type of radiation therapy called proton beam therapy (PBT) is better for protecting the heart compared to traditional photon radiation therapy (XRT) in women with certain types of breast cancer. The study aims to find out if PBT causes fewer changes to the heart as seen on MRI scans, especially for those with non-metastatic left-sided breast cancer.

To participate in the trial, women must be at least 18 years old and have been diagnosed with non-metastatic breast cancer that requires radiation treatment. They should be able to understand the study and agree to participate by signing a consent form. Women who are pregnant or breastfeeding cannot join, and there are some medical conditions that would exclude someone from participating, like severe kidney issues. If eligible, participants will receive either proton or conventional radiation therapy and will undergo MRI scans to monitor their heart health throughout the study. This research could help improve treatment options for breast cancer patients while minimizing heart risks.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • ≥18 years of age
• • Non-metastatic Breast Cancer patients who are scheduled to receive conventional left-sided or bilateral breast/chest wall RT inclusive of treatment to the internal mammary lymph nodes (IMNs)
• • Prior chemotherapy is permitted
• • Ability to understand and the willingness to sign a written informed consent document
• • No contraindication to MRI
• • Patients with right-sided breast cancer or patients with left-sided patients not requiring treatment to the IMNs, but where cardiac anatomy is determined to be unfavorable by the study PI, will be considered eligible.
• Exclusion Criteria:
• • Person who is pregnant or breastfeeding.
• • Patients receiving any other investigational agent will not be excluded from study eligibility, unless the patient is already enrolled in an interventional study evaluating cardiac toxicity. No cytotoxic therapy or radiotherapy may be used during radiation therapy.
• • Contra-indication to gadolinium contrast (e.g., chronic kidney disease)
• • Contra-indication to radiotherapy (e.g., scleroderma, p53 mutation)