Clinical trial · Interventional
Image Guided Radiotherapy (IGRT) for Prone Partial Breast Irradiation
Image Guided Radiotherapy (IGRT) for Prone Partial Breast Irradiation (PBI)
- 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)
Partial breast irradiation (PBI) is becoming a new paradigm for breast cancer radiation.\[1\] No type I or II evidence is currently available to demonstrate equivalence to standard whole breast radiotherapy, and a prospective randomized trial jointly sponsored by NSABP and RTOG (NSABP B-39 and RTOG 0413) is currently accruing patients, comparing whole breast radiotherapy to PBI, either by brachytherapy or external beam techniques (EB). Until the results of this or similar trials are available, PBI remains a research domain, and it should be offered to patients only in the context of a clinical experimental protocol.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IGRT for prone partial breast irradiation (PBI) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- IGRT of prone partial breast
- description
- IGRT for prone partial breast irradiation (PBI): All patients will be treated prone with 6 Gy/fraction delivered in 5 fractions over a 1-week period for a total dose of 30 Gy.
- interventionNames
- Other: IGRT for prone partial breast irradiation (PBI)
Primary outcomes (1)
- measure
- Measure the outcome of applying IGRT to PBI
- timeFrame
- 10 years
- description
- Apply IGRT to PBI as part of breast preservation in post-menopausal women with T1 breast cancers and acquire preliminary data on the role of this tool to assure correct targeting. Measure local recurrence within the field of conformal radiation as well as local recurrence outside the field
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Post-menopausal women defined as either: 1. at least 2 years without menstrual period or 2. patients older than 50 with serological evidence of post-menopausal status or 3. hysterectomized patients of any age with FSH confirmation of post-menopausal status * pT1 breast cancer, excised with negative margins * pN0 or sentinel node negative or N0 clinically if the tumor is \< 1 cm in size Exclusion Criteria: * Previous radiation therapy to the ipsilateral breast * Presence of a proportion of DCIS in the core biopsy specimen which is compatible with extensive intraductal component (EIC)
References
Publications (0)
Data not yet available