NCT06452485 Postoperative Re-irradiaTion With and Without HYPERthermia, or Surgery Only: Toxicity, Quality of Life and Survival in Patients With Locoregional Recurrent Breast Cancer
| NCT ID | NCT06452485 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Amsterdam UMC, location VUmc |
| Condition | Locoregional Recurrence |
| Study Type | OBSERVATIONAL |
| Enrollment | 500 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2027-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 500 participants in total. It began in 2024-02-01 with a primary completion date of 2027-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Desiree Van Den Bongard, Dr
PRINCIPAL INVESTIGATOR
Amsterdam UMC
Frequently Asked Questions
Who can join the NCT06452485 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Locoregional Recurrence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06452485 currently recruiting?
Yes, NCT06452485 is actively recruiting participants. Contact the research team at l.f.wurfbain@amsterdamumc.nl for enrollment information.
Where is the NCT06452485 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT06452485 clinical trial?
NCT06452485 is sponsored by Amsterdam UMC, location VUmc. The principal investigator is Desiree Van Den Bongard, Dr at Amsterdam UMC. The trial plans to enroll 500 participants.