Clinical trial · Interventional
Highly Accelerated Dose-Integrated Radiotherapy in 5 Fractions in Breast Cancer
Evaluation of Dose Integrated Accelerated Irradiation in Older Women (≥ 70 Year) With Early and Loco-regionally Advanced Stages of 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)
Adjuvant radiotherapy in breast cancer improves local control, also in the elderly. Hormonal therapy in hormone sensitive tumors improves results but can not substitute radiotherapy. Improved local control leads to less breast cancer related morbidity and mortality, also in an older population (Schonberg, JCO, 2011). Unfortunately, in older patients with lower life expectancy, adjuvant radiotherapy is often omitted. Following reasons are invoked: * frailty of the patient * fear for toxicity * impaired mobility, rendering transportation and positioning more difficult * dependency for transportation to and from the radiotherapy departement * negative cost effectiveness ratio, due to high cost (especially for complex techniques and long schedules) and lower benefit (lower life expectancy) Hypofractionation is feasible without increased toxicity, and combines better local control with patient comfort and lower costs. Further lowering the number of fractions (from 15-21 to 5) will further improve patient comfort, but is challenging when different doses are needed in the same target volume. This problem is addressed using advanced techniques permitting dose-integration. In the elder with cancer, several unrecognized geriatric problems, including depression and cognitive impairment, can be detected by CGA . Some problems do interact with cancer treatment. In this study screening and assessment is provided to support patients and to develop an inventory of radiotherapy obstacles. Our study includes breast cancer patients, ≥70 years old, referred for adjuvant radiotherapy after surgical treatment. A schedule of 5 fractions is offered, encompassing different targets of treatment.
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 |
| Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Dose-integrated accelerated EBRT in pN0 breast cancer | Radiation | — | UNRESOLVED |
| Dose-integrated accelerated EBRT in pN+ breast cancer | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Accelerated dose-integrated radiotherapy - pN0
- description
- Lymph node negative breast cancer
- interventionNames
- Radiation: Dose-integrated accelerated EBRT in pN0 breast cancer
- type
- EXPERIMENTAL
- label
- Accelerated dose-integrated radiotherapy - pN1
- description
- Lymph node positive breast cancer
- interventionNames
- Radiation: Dose-integrated accelerated EBRT in pN+ breast cancer
Primary outcomes (1)
- measure
- Breast retraction (LENTSOMA)
- timeFrame
- 6 weeks post-radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 70 years old * AND breast conserving surgery or mastectomy for breast carcinoma * AND multidisciplinary decision of adjuvant irradiation * AND absence of distant metastases * AND informed consent obtained, signed and dated before specific protocol procedures Exclusion Criteria: * Bilateral breast irradiation * In case of mastectomy: positive resection margin, needing boost * 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, and unlikely to complete the study * History of previous radiation treatment to the same region
References
Publications (0)
Data not yet available