TY - JOUR
T1 - Treatment of early-stage breast cancer with percutaneous thermal ablation, an open-label randomised phase 2 screening trial
T2 - Rationale and design of the THERMAC trial
AU - Van De Voort, Elles M.F.
AU - Struik, Gerson M.
AU - Koppert, Linetta B.
AU - Moelker, Adriaan
AU - Debets, Reno
AU - Yo, Glenn
AU - MacCo, Maura J.P.V.
AU - Sinke, Renata H.J.A.
AU - Franckena, Martine
AU - Birnie, Erwin
AU - Verhoef, Cornelis
AU - Klem, Taco M.A.L.
N1 - Funding Information:
This work was monetary supported by Team Westland, Stichting BOF (Foundation for the promotion of research Franciscus), Stichting Coolsingel (Coolsingel Foundation), Stichting Vrienden van het Havenziekenhuis (Friends of the Havenziekenhuis Foundation), Maurits en Anna de Kock Stichting (Maurits and Anna de Kock Foundation). Material support was provided by IceCure and AngioCare.
Publisher Copyright:
© 2021 BMJ Publishing Group. All rights reserved.
PY - 2021/9/6
Y1 - 2021/9/6
N2 - Introduction Breast 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 analysis The 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 dissemination This 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 number NL9205 (www.trialregister.nl); Pre-results.
AB - Introduction Breast 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 analysis The 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 dissemination This 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 number NL9205 (www.trialregister.nl); Pre-results.
UR - http://www.scopus.com/inward/record.url?scp=85114672674&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2021-052992
DO - 10.1136/bmjopen-2021-052992
M3 - Article
AN - SCOPUS:85114672674
VL - 11
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 9
M1 - e052992
ER -