Clinical trial · Interventional
Intraoperative Boost Radiotherapy With Electrons (IOERT) Followed By Hypofractionated Whole-Breast Irradiation (WBRT)
NCT01295723CI-TRIAL-00058414unknownN/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)
Hypofractionated intraoperative boost (HIOB) is defined as hypofractionated WBRT (40.5 Gy in 2.7 Gy per fraction) preceded by an intraoperative boost to the tumor bed (10 Gy IOERT). The HIOB study concept will test whether such a combined schedule is superior or iso-effective standard RT in terms of local control and cosmetic outcome.
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 |
|---|---|---|---|
| Invasive Lobular and Ductal Carcinoma | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hypofractionated Whole Breast Radiation Therapy | Radiation | — | UNRESOLVED |
| Intraoperative Electron Radiation Therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intraoperative Electron Radiation Therapy
- description
- A single dose of electron irradiation given at the surgical site during the operation to remove the cancerous tumor will replace the usual 5-8 days of localized radiation. Hypofractionated Whole Breast Radiation Therapy must start within 14-56 days post operatively.
- interventionNames
- Radiation: Hypofractionated Whole Breast Radiation Therapy
- Radiation: Intraoperative Electron Radiation Therapy
Primary outcomes (1)
- measure
- Assessment of acute and late toxicity
- timeFrame
- 5 years
- description
- Assessment of acute toxicity of breast irradiation according to CTC-toxicity Scoring - systems: * At the end of Radiation Therapy * At time of first follow-up investigation (week 8 - 10) Assessment of late toxicity according to NSABP scoring - systems at 6, 12, 24, 36, 48, and 60 months
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Histological proven invasive breast carcinoma (ductal and lobular) * Age \> 40 years * Karnofsky performance status \>70% * Single discrete tumor or focal microcalcifications that can be imaged on a specimen radiograph or multifocal disease within the same quadrant with a maximum dimension of 4 cm (invasive foci) * Nodal Status: NO-1 * Clear surgical margins: R0; min 2mm. Re-excision after IOERT is permitted but not required to achieve (-) margin. * All grades G1 - G3 * Any hormonal receptor and Her-2 status * Informed consent Exclusion Criteria: * In-situ Carcinoma without invasive component or multifocal disease \> 4 cm * Tumor stage: T3 or 4 * Nodal Status \> N1 pathologically * Surgical margins \< 2mm * Multicentricity * Previous radiotherapy to the involved breast * Karnofsky Index \< 70% * Mixed connective tissue diseases e.g. rheumatoid polyarthritis, thromboangitis obliterans, systemic lupus. * Distant metastases * Unable to provide written consent
References
Publications (0)
Data not yet available
No reference posted for this study.