ACTIVE_NOT_RECRUITING

Ultrahypofractionation and Normal Tissue Toxicity

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Conditions

Breast CancerBreast Cancer FemaleBreast Cancer Stage IIBreast Cancer Stage IIIMyocardial FibrosisRadiation TherapyPhoton Radiation TherapyXRTProton Beam Radiation TherapyPBT

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Official Title

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

Quick Facts

Study Start:2023-08-15
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05912231

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥18 years of age
  2. * 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)
  3. * Prior chemotherapy is permitted
  4. * Ability to understand and the willingness to sign a written informed consent document
  5. * No contraindication to MRI
  6. * 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.
  1. * Person who is pregnant or breastfeeding.
  2. * 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.
  3. * Contra-indication to gadolinium contrast (e.g., chronic kidney disease)
  4. * Contra-indication to radiotherapy (e.g., scleroderma, p53 mutation)

Contacts and Locations

Principal Investigator

Rachel Jimenez, MD
PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Rachel Jimenez, MD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-15
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2023-08-15
Study Completion Date2026-12-31

Terms related to this study

Keywords Provided by Researchers

  • Radiation Therapy
  • Photon Radiation Therapy
  • XRT
  • Proton Beam Radiation Therapy
  • PBT
  • Breast Cancer
  • Breast Cancer Female
  • Breast Cancer Stage II
  • Breast Cancer Stage III
  • Myocardial Fibrosis

Additional Relevant MeSH Terms

  • Breast Cancer
  • Breast Cancer Female
  • Breast Cancer Stage II
  • Breast Cancer Stage III
  • Myocardial Fibrosis