Clinical trial · Observational
Proton vs Photon IMRT Toxicity in Breast Cancer
Comparative Toxicity of Postoperative Proton Versus Photon Intensity-Modulated Radiotherapy(IMRT) in Breast Cancer: A Multicenter, Prospective, Observational Study
- 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 study aims to compare the differences in acute and long-term toxicities between intensity-modulated proton therapy (IMPT) and intensity-modulated photon radiotherapy (IMRT/VMAT) in postoperative breast cancer patients, with a focus on evaluating their impact on critical organs, including the heart, lungs, skin, esophagus, thyroid, and lymphatic tissues. Eligible patients will be followed for at least one year to assess the incidence and severity of both acute and late toxicities, as well as differences in patient-reported outcomes (PROs), cosmetic outcomes following breast-conserving surgery, and overall quality of life.
Conditions
Conditions (1)
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 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Intensity-modulated photon radiotherapy (IMRT/VMAT) | Radiation | — | UNRESOLVED |
| Intensity-modulated proton therapy (IMPT) | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Intensity-modulated photon radiotherapy (IMRT/VMAT)
- description
- Participants will receive photon intensity-modulated radiation therapy (IMRT) targeting the whole breast or chest wall, with or without regional lymph node irradiation (including the ipsilateral supraclavicular, infraclavicular, and high-risk axillary lymph node regions, and optionally the internal mammary lymph node regions).
- interventionNames
- Radiation: Intensity-modulated photon radiotherapy (IMRT/VMAT)
- label
- Intensity-modulated proton therapy (IMPT)
- description
- Participants will receive photon Intensity-modulated proton therapy (IMPT) targeting the whole breast or chest wall, with or without regional lymph node irradiation (including the ipsilateral supraclavicular, infraclavicular, and high-risk axillary lymph node regions, and optionally the internal mammary lymph node regions).
- interventionNames
- Radiation: Intensity-modulated proton therapy (IMPT)
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female patients aged ≥18 years. 2. Pathological diagnosis of invasive breast cancer or ductal carcinoma in situ. 3. Undergone breast-conserving surgery or total mastectomy, with or without stage I breast reconstruction. 4. For invasive carcinoma, sentinel lymph node biopsy, axillary lymph node sampling, or axillary lymph node dissection was performed. 5. Required postoperative adjuvant radiotherapy. 6. Karnofsky Performance Status (KPS) score ≥ 70. 7. The estimated life expectancy of greater than 5 years . 8. Planned to receive photon intensity-modulated radiotherapy (IMRT) or proton IMRT, with written informed consent obtained. Exclusion Criteria: 1. Prior history of chest radiotherapy. 2. Severe cardiopulmonary dysfunction or other conditions that contraindicate radiotherapy. 3. Pregnancy or breastfeeding. 4. Concurrent active malignancies.
References
Publications (0)
Data not yet available