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| Name | Class |
|---|---|
| Borstkanker Onderzoek Groep | NETWORK |
| Comprehensive Cancer Centre The Netherlands | OTHER |
| Dutch Cancer Society | OTHER |
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In the Netherlands, breast cancer patients with locoregional recurrence (LRR) and high-risk factors are treated with 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 comparing postoperative re-irradiation and hyperthermia-treatment in high-risk LRR patients.
The optimal management of LRR breast cancer is multidisciplinary, and based on various prognostic risk factors and previous treatments. The surgical treatment of local recurrences is salvage mastectomy after previous breast-conserving therapy, or local excision after previous mastectomy. Regional treatment of tumor-positive lymph nodes consists of axillary radiotherapy and/or lymph node dissection. High-risk LRR patients have an indication for postoperative irradiation to improve locoregional control and disease-free survival. In previously irradiated high-risk LRR patients, postoperative re-irradiation is administered with or without hyperthermia in the Netherlands depending on the treating center and treating professional. Before the preoperative systemic treatment era, primary re-irradiation with hyperthermia was the evidence-based standard of care in high-risk unresectable LRR. Hyperthermia was used to increase the therapeutic efficacy of re-irradiation. The introduction of preoperative systemic therapy in 2010 resulted in more resectable high-risk LRRs. This resulted in postoperative re-irradiation instead of primary re-irradiation in LRR patients, including variation in the use of hyperthermia. There is no evidence-based standard of care regarding the combination of postoperative re-irradiation with or without hyperthermia in high-risk LRR patients. The major problem is that only retrospective data and no prospective (randomized) data is available on oncological outcomes (survival and recurrence) and toxicity following postoperative re-irradiation and hyperthermia. Consequently, there is a high need to assess oncological outcomes and toxicity of postoperative re-irradiation with or without hyperthermia in a randomized controlled trial (RCT). So far, an RCT has not been feasible due to the large variation in postoperative re-irradiation and hyperthermia, and preferences regarding hyperthermia-treatment by professionals. In the RT-HYPE study, the investigators evaluate oncological outcomes, toxicity and quality of life in high-risk LRR patients, including the harmonization of hyperthermia-treatment. The results of the RT-HYPE study are needed for the optimization of the shared decision making (SDM) process on post-operative re-irradiation with or without hyperthermia, between professionals and patients. In addition, these results allow to set-up a future RCT comparing postoperative re-irradiation with and without hyperthermia treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Postoperative re-irradiation with hyperthermia | Postoperative re-irradiation with hyperthermia in patients with locoregional recurrent breast cancer |
| |
| Postoperative re-irradiation without hyperthermia | Postoperative re-irradiation without hyperthermia in patients with locoregional recurrent breast cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No interventions, patient-reported outcomes (PROMs) and toxicity will be collected in both groups. | Other | Patients will receive standard of care. Patients need to fill in questionnaires, these are additional interventions for the included subject. Questionnaires for patient-reported outcomes (PROMs) and toxicity will be filled in one week before treatment, one week before re-irradiation, one week and three months after re-irradiation, one, two and five years after surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported toxicity according to PRO-CTCAE in LRR patients | Patient-reported toxicity according to PRO-CTCAE after a median follow-up of five years after diagnosis of (subsequent) LRR disease. | Five years |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life at 2 and 5 years after diagnosis of LRR disease | EORTC-C30 | at 2 and 5 years after diagnosis of LRR disease |
| Quality of Life at 2 and 5 years after diagnosis of LRR disease | EORTC -BR45 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients aged 18 years and older with an indication for postoperative re-irradiation with or without hyperthermia, eligible patients with a LRR with high-risk characteristics treated with mastectomy/local excision and postoperative re-irradiation, or mastectomy/local excision and postoperative re-irradiation with hyperthermia. Patients also treated with (neo-)adjuvant systemic treatment and/or with oligometastases (<=5 metastases), are allowed to be part of the study population.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisca Wurfbain, MD | Contact | +31 6-25414750 | l.f.wurfbain@amsterdamumc.nl | |
| Desiree Van Den Bongard, Dr | Contact | +31 6-25414750 | h.j.vandenbongard@amsterdamumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Desiree Van Den Bongard, Dr | Amsterdam UMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Recruiting | Amsterdam | Netherlands |
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|
| at 2 and 5 years after diagnosis of LRR disease |
| LRR-free survival in LRR patients | at 2 and 5 years after diagnosis of LRR disease |
| distant metastasis-free survival in LRR patients | at 2 and 5 years after diagnosis of LRR disease |
| breast-cancer event-free survival in LRR patients | at 2 and 5 years after diagnosis of LRR disease |
| overall survival in LRR patients | at 2 and 5 years after diagnosis of LRR disease |
| Referral patterns in patients diagnosed with LRR | Referral patterns (per institute, professional, patient-related factors including performance status, and travel distance). | 5 year |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000071066 | Patient Reported Outcome Measures |
| ID | Term |
|---|---|
| D019538 | Health Care Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D006302 | Health Services Research |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D063868 | Patient Outcome Assessment |
| D017063 | Outcome Assessment, Health Care |
| D010043 | Outcome and Process Assessment, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
| D017531 | Health Care Evaluation Mechanisms |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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