Treatment of early-stage breast cancer with percutaneous thermal ablation, an open-label randomised phase 2 screening trial
| Autor: | Reno Debets, Adriaan Moelker, Martine Franckena, Elles M F van de Voort, Glenn Yo, Linetta B. Koppert, Taco M A L Klem, Maura J P V Macco, Erwin Birnie, Gerson M. Struik, Cornelis Verhoef, R. Sinke |
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| Přispěvatelé: | Surgery, Radiology & Nuclear Medicine, Medical Oncology, Radiotherapy, Health Psychology Research (HPR) |
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Breast Neoplasms/surgery medicine.medical_treatment Breast surgery Breast Neoplasms breast tumours Malignancy quality in health care Breast cancer SDG 3 - Good Health and Well-being medicine Humans Stage (cooking) Survival rate Early Detection of Cancer clinical trials business.industry breast imaging Cryoablation General Medicine breast surgery Ablation medicine.disease Neoadjuvant Therapy Clinical trial Treatment Outcome Oncology Quality of Life Medicine Female Radiology business surgical pathology |
| Zdroj: | BMJ Open, 11(9):e052992. BMJ Publishing Group BMJ Open, Vol 11, Iss 9 (2021) BMJ Open BMJ Open, 11:e052992. BMJ PUBLISHING GROUP |
| ISSN: | 2044-6055 |
| Popis: | IntroductionBreast cancer is the most frequently diagnosed malignancy worldwide but almost half of the patients have an excellent prognosis with a 5-year survival rate of 98%–99%. These patients could potentially be treated with thermal ablation to avoid surgical excision, reduce treatment-related morbidity and increase patients’ quality of life without jeopardising treatment effectiveness. Previous studies showed highest complete ablation rates for radiofrequency, microwave and cryoablation. However, due to heterogeneity among studies, it is unknown which of these three techniques should be selected for a phase 3 comparative study.Methods and analysisThe aim of this phase 2 screening trial is to determine the efficacy rate of radiofrequency, microwave and cryoablation with the intention to select one treatment for further testing in a phase 3 trial. Additionally, exploratory data are obtained for the phase 3 trial. The design is a multicentre open-label randomised phase 2 screening trial. Patients with unifocal, invasive breast cancer with a maximum diameter of 2 cm without lymph node or distant metastases are included. Triple negative, Bloom-Richardson grade 3 tumours and patients with an indication for neoadjuvant chemotherapy will be excluded. Included patients will be allocated to receive one of the three thermal ablation techniques. Three months later surgical excision will be performed to determine the efficacy of thermal ablation. Treatment efficacy in terms of complete ablation rate will be assessed with CK 8/18 and H&E staining. Secondary outcomes include feasibility of the techniques in an outpatient setting, accuracy of MRI for complete ablation, patient satisfaction, adverse events, side effects, cosmetic outcome, system usability and immune response.Ethics and disseminationThis study protocol was approved by Medical Research Ethics Committee of the Erasmus Medical Center, Rotterdam, the Netherlands. Study results will be submitted for publication in peer-reviewed journals.Trial registration numberNL9205 (www.trialregister.nl); Pre-results. |
| Databáze: | OpenAIRE |
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