Clinical trial · Interventional
Outcome of 15 Versus 5 Fractions in Adjuvant Breast Radiotherapy in Women Over 65 Years
A Partially Randomized Patient Preference Trial, Comparing Adjuvant Hypofractionated Radiotherapy in 15 Versus 5 Fractions After Breast Conserving Surgery or Mastectomy for Early or Locally Advanced Breast Cancer in Women Above 65 Years
- 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)
This study will evaluate the effect of highly accelerated external beam radiotherapy (EBRT) in 5 fractions over 10 days compared to 15 fractions over 3 weeks for early as well as locally-advanced stage breast cancer. Primary endpoint will be chronic toxicity (breast deformation and retraction). Secondary endpoints are acute toxicity, loco-regional and distant tumor control, patient reported QoL and cosmetic satisfaction. Patients with lymph node irradiation will be closely monitored for radiation induced plexopathy.
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 |
|---|---|---|---|
| Breastcancer | — | UNRESOLVED | — |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| LNI 15 fractions | Radiation | — | UNRESOLVED |
| LNI 5 fractions | Radiation | — | UNRESOLVED |
| SIB 15 fractions if needed | Radiation | — | UNRESOLVED |
| SIB 5 fractions if needed | Radiation | — | UNRESOLVED |
| TWI 15 fractions | Radiation | — | UNRESOLVED |
| TWI 5 fractions | Radiation | — | UNRESOLVED |
| WBI 15 fractions | Radiation | — | UNRESOLVED |
| WBI 5 fractions | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (10)
- type
- EXPERIMENTAL
- label
- WBI - randomized - 5
- description
- WBI 5 fractions SIB 5 fractions if needed
- interventionNames
- Radiation: WBI 5 fractions
- Radiation: SIB 5 fractions if needed
- type
- ACTIVE_COMPARATOR
- label
- WBI - randomized - 15
- description
- WBI 15 fractions SIB 15 fractions if needed
- interventionNames
- Radiation: WBI 15 fractions
- Radiation: SIB 15 fractions if needed
- type
- EXPERIMENTAL
- label
- WBI - observational - 5
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * breast conserving surgery or mastectomy for breast carcinoma * multidisciplinary decision of adjuvant irradiation * absence of distant metastases * informed consent obtained, signed and dated before specific protocol procedures Exclusion Criteria: * History of previous radiation treatment to the same region * Bilateral breast irradiation * Life expectancy of less than 2 years * Planned reconstructive breast surgery * Condition making toxicity evaluation difficult, e.g. skin disorders, pre-existing brachial plexus injury, … * Inability to respect constraints on skin, heart, lungs, esophagus, ribs, brachial plexus or any other organ at risk * Mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study * Patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits or unlikely to complete the study
References
Publications (0)
Data not yet available