Clinical trial · Interventional
Ultrahypofractionation and Normal Tissue Toxicity
Proton Versus Photon Ultrahypofractionated Radiation Therapy and Its Impact on Normal Tissue
NCT05912231CI-TRIAL-00097192active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Breast Cancer Female | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Breast Cancer Stage II | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Breast Cancer Stage III | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
| Myocardial Fibrosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Accelerated Photon Radiation Therapy (XRT) | Radiation | — | UNRESOLVED |
| Accelerated Proton Beam Radiation Therapy (PBT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Accelerated Proton Beam Radiation Therapy (PBT) Group
- description
- 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.
- interventionNames
- Radiation: Accelerated Proton Beam Radiation Therapy (PBT)
- type
- EXPERIMENTAL
- label
- Accelerated Photon Radiation Therapy (XRT) Group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.