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NCT05912231 | RECRUITING | Breast Cancer

Ultrahypofractionation and Normal Tissue Toxicity
Sponsor:

Massachusetts General Hospital

Information provided by (Responsible Party):

Rachel Beth Jimenez

Brief Summary:

This research is being done to see if proton beam radiation therapy (PBT) results in fewer changes to a participant's heart measured with MRI-imaging than conventional or "photon" radiation therapy (XRT) for participants with non-metastatic left sided breast cancer. The names of the two study groups in this research study are: * Proton Radiation Therapy (PBT) * Conventional or "Photon" Radiation Therapy (XRT)

Condition or disease

Breast Cancer

Breast Cancer Female

Breast Cancer Stage II

Breast Cancer Stage III

Myocardial Fibrosis

Intervention/treatment

Accelerated Proton Beam Radiation Therapy (PBT)

Accelerated Photon Radiation Therapy (XRT)

Phase

NA

Detailed Description:

This is a randomized phase II trial comparing participants with stage II-III breast cancer treated with accelerated Proton Beam Radiation Therapy (PBT) versus accelerated conventional photon radiation therapy (XRT) inclusive of the regional lymph nodes. Participants will be randomized into one of two study groups: proton beam radiation therapy versus photon radiation therapy. Randomization means that participants are put into a group by chance. Study procedures includes screening for eligibility, study treatment visits, Cardiac Magnetic Resonance Imaging (MRI), blood tests, and questionnaires. The National Cancer Institute, American Society of Clinical Oncology, and Claflin Grant are supporting this research by providing funding for the research study.

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : Proton Versus Photon Ultrahypofractionated Radiation Therapy and Its Impact on Normal Tissue
Actual Study Start Date : 2023-08-15
Estimated Primary Completion Date : 2025-09-17
Estimated Study Completion Date : 2025-09-17

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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)
Ultrahypofractionation and Normal Tissue Toxicity

Location Details

NCT05912231

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How to Participate

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Locations

RECRUITING

United States, Massachusetts

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States, 02215