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Tytuł pozycji:

Phase I feasibility study of Magnetic Resonance guided High Intensity Focused Ultrasound-induced hyperthermia, Lyso-Thermosensitive Liposomal Doxorubicin and cyclophosphamide in de novo stage IV breast cancer patients: study protocol of the i-GO study

Tytuł:
Phase I feasibility study of Magnetic Resonance guided High Intensity Focused Ultrasound-induced hyperthermia, Lyso-Thermosensitive Liposomal Doxorubicin and cyclophosphamide in de novo stage IV breast cancer patients: study protocol of the i-GO study
Autorzy:
Elsken van der Wall
Josanne S de Maar
Britt B M Suelmann
Manon N G J A Braat
H H B Vaessen
Arjen J Witkamp
S C Linn
Chrit T W Moonen
Roel Deckers
Temat:
Medicine
Źródło:
BMJ Open, Vol 10, Iss 11 (2020)
Wydawca:
BMJ Publishing Group, 2020.
Rok publikacji:
2020
Kolekcja:
LCC:Medicine
Typ dokumentu:
article
Opis pliku:
electronic resource
Język:
English
ISSN:
2044-6055
Relacje:
https://bmjopen.bmj.com/content/10/11/e040162.full; https://doaj.org/toc/2044-6055
DOI:
10.1136/bmjopen-2020-040162
Dostęp URL:
https://doaj.org/article/c3c7040d140341f3a463f16136639988  Link otwiera się w nowym oknie
Numer akcesji:
edsdoj.3c7040d140341f3a463f16136639988
Czasopismo naukowe
Introduction In breast cancer, local tumour control is thought to be optimised by administering higher local levels of cytotoxic chemotherapy, in particular doxorubicin. However, systemic administration of higher dosages of doxorubicin is hampered by its toxic side effects. In this study, we aim to increase doxorubicin deposition in the primary breast tumour without changing systemic doxorubicin concentration and thus without interfering with systemic efficacy and toxicity. This is to be achieved by combining Lyso-Thermosensitive Liposomal Doxorubicin (LTLD, ThermoDox, Celsion Corporation, Lawrenceville, NJ, USA) with mild local hyperthermia, induced by Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU). When heated above 39.5°C, LTLD releases a high concentration of doxorubicin intravascularly within seconds. In the absence of hyperthermia, LTLD leads to a similar biodistribution and antitumour efficacy compared with conventional doxorubicin.Methods and analysis This is a single-arm phase I study in 12 chemotherapy-naïve patients with de novo stage IV HER2-negative breast cancer. Previous endocrine treatment is allowed. Study treatment consists of up to six cycles of LTLD at 21-day intervals, administered during MR-HIFU-induced hyperthermia to the primary tumour. We will aim for 60 min of hyperthermia at 40°C–42°C using a dedicated MR-HIFU breast system (Profound Medical, Mississauga, Canada). Afterwards, intravenous cyclophosphamide will be administered. Primary endpoints are safety, tolerability and feasibility. The secondary endpoint is efficacy, assessed by radiological response.This approach could lead to optimal loco-regional control with less extensive or even no surgery, in de novo stage IV patients and in stage II/III patients allocated to receive neoadjuvant chemotherapy.Ethics and dissemination This study has obtained ethical approval by the Medical Research Ethics Committee Utrecht (Protocol NL67422.041.18, METC number 18-702). Informed consent will be obtained from all patients before study participation. Results will be published in an academic peer-reviewed journal.Trial registration numbers NCT03749850, EudraCT 2015-005582-23.

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