Clinical trial · Interventional
Prospective Phase II Study of Intraoperative Radiotherapy (IORT) in Elderly Patients with Small Breast Cancer
TARGIT-E(Elderly) Prospective Phase II Study of Intraoperative Radiotherapy (IORT) in Elderly Patients with Small 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)
This prospective, multicentric single arm phase II study is based on the protocol of the international TARGIT-A study. The purpose is to investigate the efficacy of a single intraoperative radiotherapy treatment within elderly low risk patients (≥ 70 years, cT1, cN0, cM0, invasive-ductal) which is followed by WBRT only when risk factors are present. In presence of risk factors postoperative WBRT will be added to complete the radiotherapeutic treatment according to international guidelines.
Conditions
Conditions (4)
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 Diseases | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Neoplasm Recurrence, Local | — | UNRESOLVED | — |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intraoperative radiotherapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intraoperative radiotherapy
- description
- single arm with intraoperative radiotherapy
- interventionNames
- Radiation: intraoperative radiotherapy
Primary outcomes (1)
- measure
- Local Relapse
- timeFrame
- up to ten years
- description
- Rate of local relapse (within 2cm of the initial tumor bed)
Secondary outcomes (5)
- measure
- Overall Survival
- timeFrame
- up to ten years
- description
- Death is an event
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * cT1c cN0 cM0 * ≥ 70 years old * invasive-ductal histology * compliance * informed consent Exclusion Criteria: * extensive intraductal component (EIC) * multifocality /-centricity * lymph vessel invasion (L1) * clinical signs of distant metastases or clinically suspicious lymph nodes * other histology * \< 70 years old * missing informed consent or non-compliance * bilateral breast cancer at time of diagnosis * known BRACA 1/2 mutations (genetic testing not required)
References
Publications (2)
- DERIVEDSperk E, Lemanski C, Neumaier C, Lauer J, Siefert V, Volker R, Lindner C, Niehoff P, Tallet AR, Racadot S, Petit A, Pazos M, Le-Blanc Onfroy M, Martin E, Reuter C, Hermann RM, Pohl F, Friedrichs K, Wurschmidt F, Pigorsch S, Kolberg HC, Graf H, Brunner TB, Malter W, Park-Simon TW, Brucker C, Fleckenstein J, Petersen C, Tuschy B, Wilken EE, Buttner S, Sutterlin M, Flyger H, Wenz F. Intraoperative radiotherapy in elderly patients with breast cancer: long-term follow-up results of the prospective phase II trial TARGIT-E. BMC Cancer. 2025 Dec 4;25(1):1862. doi: 10.1186/s12885-025-15289-0. PMID 41345599
- DERIVEDNeumaier C, Elena S, Grit W, Yasser AM, Uta KT, Anke K, Axel G, Marc S, Frederik W. TARGIT-E(lderly)--prospective phase II study of intraoperative radiotherapy (IORT) in elderly patients with small breast cancer. BMC Cancer. 2012 May 8;12:171. doi: 10.1186/1471-2407-12-171. PMID 22569123