Clinical trial · Interventional
Clinical Trial of The Use of Bolus in Post Mastectomy Irradiation in Breast Cancer
Randomized Clinical Trial of the Impact of the Use of Bolus in the Treatment of Post Mastectomy Radiotherapy for Breast Cancer
- 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)
The aim of this study is to evaluate the impact of adding bolus in adjuvant radiotherapy after mastectomy, in relation to the time of treatment interruption and acute effects. This study evaluates whether there is an increase in treatment time with the addition of the bolus, which can overshadow the benefit of increased dose to the skin and subcutaneous tissue. The patients will continue to be followed for oncologic outcomes, focusing on chest wall local control.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Radiodermatitis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Alternate Bolus | Radiation | — | UNRESOLVED |
| Continuous Bolus | Radiation | — | UNRESOLVED |
| No Bolus | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- OTHER
- label
- Standard Risk - No bolus
- description
- No Bolus
- interventionNames
- Radiation: No Bolus
- type
- OTHER
- label
- Standard Risk - Alternate Bolus
- description
- Alternate 5mm Bolus
- interventionNames
- Radiation: Alternate Bolus
- type
- OTHER
- label
- High Risk - Alternate Bolus
- description
- Alternate 5mm Bolus
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Undergoing mastectomy with or without reconstruction of early breast * breast malignancy histologically proven * protocol addended to allow inclusion of men that meet all inclusion criteria Exclusion Criteria: * Karnofsky Performance Scale (KPS) \<70% * Concomitant chemotherapy (only permitted or hormone therapy molecular-targeted) * Prior ipsilateral thoracic / cervical irradiation * Proven metastatic disease (excluded from oncologic outcomes analyses)
References
Publications (0)
Data not yet available