Clinical trial · Interventional
Trial to Compare Radiation Fibrosis With Five Versus Three Fractions
Prone Partial Breast Irradiation (PBI): Prospective Randomized Controlled Non-inferiority Trial to Compare Radiation Fibrosis With Five Versus Three Fractions
- 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)
Post meno-pausal women with T1 Breast cancers will be randomized to receive either 600 centiGray (cGy) X 5 over five consecutive days (arm 1) versus 800 cGy X 3 fractions given every other day (arm 2). Patients will complete treatment in one week. All patients will be followed a month after the completion of treatment then q6 months for the first year, then yearly for the next 10 years.
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 |
|---|---|---|---|
| Malignant Neoplasm of Breast Stage I | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Arm 1 600 cGY x 5 fractions | Radiation | — | UNRESOLVED |
| Arm 2 800 cGY x 3 fractions | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Arm 1 - 600 cGY x 5 fractions
- description
- Patients will receive 600 cGY x 5 fractions of radiation therapy over 5 consecutive days.
- interventionNames
- Radiation: Arm 1 600 cGY x 5 fractions
- type
- OTHER
- label
- Arm 2 - 800 cGY x 3 fractions
- description
- Patients will receive 800 cGY x 3 fractions of radiation therapy every other day for 3 days.
Primary outcomes (1)
- measure
- Number of participants with grade 2 or 3 fibrosis between the two treatment groups will be compared.
- timeFrame
- 60 months
- description
- The primary analysis will be the difference in proportions of patients with grade 2 or 3 fibrosis between the two treatment groups compared using a non-inferiority z- test. The proportions of patients by grade of fibrosis will be compared in the two treatment arms using contingency table methods and chi square tests.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 50 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Post-menopausal women with status post segmental mastectomy defined as either 1) at least 2 years without menstrual period or 2) or patients older than 50 with serological evidence of post-menopausal status or 3) hysterectomized patients of any age with Follicle Stimulating Hormone (FSH) confirmation of post-menopausal status. 2. Stage 1 (pT1) breast cancer, excised with negative margins. 3. clinically N0 or No Regional Lymph node (pN0) or sentinel node negative Exclusion Criteria: 1. Previous radiation therapy to the ipsilateral breast. 2. Presence of a proportion of Ductal Carcinoma in-situ (DCIS) in the core biopsy specimen which is compatible with extensive intraductal component (EIC).
References
Publications (0)
Data not yet available