Clinical trial · Interventional
Hypofractionated Radiotherapy in Breast Cancer
A Pilot Study of Hypofractionated Simultaneous Integrated Boost Radiotherapy in Stage 0, I and III Breast Cancer Patients
- 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)
As the number of breast cancer (BrCA) survivors has markedly increased, clinicians are now seeking to reduce treatment-related toxicities and inconveniences of treatment, namely the traditional 6 weeks of daily radiation treatment (XRT). Skin thickening, fibrosis, and edema are some of the most common acute and potentially long-term debilitating toxicities of BrCA XRT. The purpose of this study is to learn if three weeks of daily radiation treatment (RT) to the breast is safe in breast cancer patients who are usually prescribed 6 weeks of daily radiation after breast surgery (e.g. lumpectomy or mastectomy) as standard of care.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer, Breast | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Inflammation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated Simultaneous Integrated Boost Radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Participants with Stage 0-III breast cancer
- description
- Women with Stage 0-III breast cancer, treated with breast conserving surgery or mastectomy and clear margins, will receive 15 doses of radiation over three weeks.
- interventionNames
- Radiation: Hypofractionated Simultaneous Integrated Boost Radiotherapy
Primary outcomes (3)
- measure
- Number of Participants Per Cutaneous Toxicity Grade (0, 1, 2, 3, 4)
- timeFrame
- Duration of Study (Up to 18 months)
- description
- Cutaneous toxicity rate will be assessed by the National Cancer Institute - Common Toxicity Criteria (NCI-CTC) v.3 grading scale. THe NCI CTCAE grades go from 0 to 4. Grade 0: none. Grade 1: Mild or localized; topical intervention indicated. Grade 2: Intense or widespread; intermittent; skin changes from scratching (e.g., edema, papulation, excoriations, lichenification, oozing/crusts); limiting instrumental ADLs. Grade 3-4: Severe or life-threatening. The higher the grade, the worse the outcome.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: Participants must have one or more of the following characteristics and be eligible for breast or chest wall with or without regional nodal radiotherapy: * Prior Chemotherapy for Breast Cancer * Greater than 25 cm of breast separation (the largest distance on an axial slice of the planning CT simulation scan between the entry and exit points of the radiation beam on the body) * Non-Caucasian Race * Less than or equal to 50 years of age * Requiring regional nodal irradiation without evidence of N3 disease Exclusion Criteria: * Males will be excluded * Women who are pregnant or nursing a child may not take part in this study
References
Publications (0)
Data not yet available