Clinical trial · Observational
Postoperative Re-irradiaTion With and Without HYPERthermia, or Surgery Only: Toxicity, Quality of Life and Survival in Patients With Locoregional Recurrent 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)
In the Netherlands, breast cancer patients with locoregional recurrence (LRR) and intermediate- and high-risk factors are treated with surgery with or without postoperative re-irradiation with or without hyperthermia. Retrospective studies showed that 3-year locoregional control after postoperative re-irradiation with hyperthermia was 68-83%, and severe toxicity in up to 40% of LRR patients. Unfortunately, no prospective (randomized) data are available on clinical outcomes. Consequently, variation exists in hyperthermia-treatment and re-irradiation schedules. Prospective real-world data on oncological outcomes, toxicity and quality of life is highly needed for shared decision-making between patients and professionals. These data will be used in the design of a future randomized trial in high-risk LRR patients.
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 Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Hyperthermia | — | UNRESOLVED | — |
| Locoregional Recurrence | — | UNRESOLVED | — |
| Re-irradiation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No interventions, patient-reported outcomes (PROMs) and toxicity will be collected in both groups. | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Postoperative re-irradiation with hyperthermia
- description
- Postoperative re-irradiation with hyperthermia in patients with locoregional recurrent breast cancer
- interventionNames
- Other: No interventions, patient-reported outcomes (PROMs) and toxicity will be collected in both groups.
- label
- Postoperative re-irradiation without hyperthermia
- description
- Postoperative re-irradiation without hyperthermia in patients with locoregional recurrent breast cancer
- interventionNames
- Other: No interventions, patient-reported outcomes (PROMs) and toxicity will be collected in both groups.
- label
- surgery only
- description
- Patients who do not receive postoperative re-irradiation after salvage mastectomy.
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion criteria: * ≥ 18 years old * WHO performance scale ≤ 2 * Diagnosed with local +/- regional recurrence (LRR) (i.e. true recurrence or second primary) with high-risk tumor characteristics\* and previously treated with postoperative local +/- regional irradiation for primary breast cancer/previous recurrence with an indication for salvage mastectomy with/without postoperative re-irradiation (+/-hyperthermia)\*\* if re-irradiation: including overlap of re-irradiated volume with previous irradiated volume * Diagnosed with a chest wall recurrence and treated with local excision with/without NAST and postoperative re irradiation with/without hyperthermia. In patients with a clinical/radiological complete response after neoadjuvant systemic treatment, NO surgery and re irradiation (+/- hyperthermia) (since surgery is not possible in this group) * (Neo-)adjuvant systemic (NAST) treatment is allowed * Use of PET(FES/FDG)-CT for staging of nodal and disseminated disease * Oligometastases in lymph nodes in the mediastinum, neck, contralateral axillary/supraclavicular region (up to a maximal number of five) is allowed * Proficient in Dutch at a level allowing to understand the questionnaires and patient information sheet \* Definition of high-risk tumor characteristics are: * (Focal) irradical resection * All clinical and pathological stages except for low-risk LRR: - rcT1-2N0 - r(y)pT1-2N0 \*\* according to local clinical practice and/or shared decision making process Exclusion criteria: • Diagnosed with primary breast sarcoma
References
Publications (0)
Data not yet available