Proton Versus Photon Ultrahypofractionated Radiation Therapy and Its Impact on Normal Tissue

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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)

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥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.

Locations
United States
Massachusetts
Massachusetts General Hospital Cancer Center
RECRUITING
Boston
Contact Information
Primary
Rachel Jimenez, MD
RBJIMENEZ@PARTNERS.ORG
617-726-8651
Time Frame
Start Date: 2023-08-15
Estimated Completion Date: 2025-09-17
Participants
Target number of participants: 60
Treatments
Experimental: Accelerated Proton Beam Radiation Therapy (PBT) Group
Participants will be randomized 1:1 to XRT group and stratified by receipt of chemotherapy and cardiac risk factors and will complete:~* Cardiac MRI and blood tests within 1 month prior to start of radiation therapy.~* Radiation therapy 1x daily for 5 days over 1 week.~* End of radiation therapy visit with blood tests.~* 6 month follow up visit with cardiac MRI, blood tests, questionnaires, and photographic imaging.~* 12 month follow up visit with questionnaires and photographic imaging.
Experimental: Accelerated Photon Radiation Therapy (XRT) Group
Participants will be randomized 1:1 to XRT group and stratified by receipt of chemotherapy and cardiac risk factors and will complete:~* Cardiac MRI and blood tests within 1 month prior to start of radiation therapy.~* Radiation therapy 1x daily for 5 days over 1 week.~* End of radiation therapy visit with blood tests.~* 6 month follow up visit with cardiac MRI, blood tests, questionnaires, and photographic imaging.~* 12 month follow up visit with questionnaires and photographic imaging.
Related Therapeutic Areas
Sponsors
Collaborators: American Society of Clinical Oncology, National Cancer Institute (NCI)
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov