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70. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie (DGNC)
Joint Meeting mit der Skandinavischen Gesellschaft für Neurochirurgie

Deutsche Gesellschaft für Neurochirurgie (DGNC) e. V.

12.05. - 15.05.2019, Würzburg

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PriCoTTF – a phase I/II trial of tumour treating fields prior and concomitant to radiotherapy in newly diagnosed glioblastoma

PriCoTTF – eine Phase I/II Studie zu Tumortherapiefeldern vorausgehend und konkomitant zu Strahlentherapie und Temozolomid im neudiagnostizierten Glioblastom

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  • Martin Glas - Universitätsklinikum Essen, Klinische Neuroonkologie, Essen, Deutschland; Universität Duisburg-Essen, Westdeutsches Tumorzentrum (WTZ), Essen, Deutschland
  • Björn Scheffler - Deutsches Konsortium für Translationale Krebsforschung (DKTK), Partner Site Universitätsklinikum Essen, DKFZ-Division Translational Neurooncology at the West German Cancer Center (WTZ), Essen, Deutschland
  • presenting/speaker Lazaros Lazaridis - Universitätsklinikum Essen, Klinische Neuroonkologie, Essen, Deutschland; University Duisburg-Essen, Westdeutsches Tumorzentrum (WTZ), Essen, Deutschland
  • Ulrich Herrlinger - Universität Bonn, Klinische Neuroonkologie, Bonn, Deutschland
  • Daniela Pierscianek - Universität Duisburg-Essen, Westdeutsches Tumorzentrum (WTZ), Essen, Deutschland; Universitätsklinikum Essen, Klinik für Neurochirurgie, Essen, Deutschland
  • Ulrich Sure - Universität Duisburg-Essen, Westdeutsches Tumorzentrum (WTZ), Essen, Deutschland; Universitätsklinikum Essen, Klinik für Neurochirurgie, Essen, Deutschland
  • Martin Proescholdt - Universität Regensburg, Klinik für Neurologie, Regensburg, Deutschland
  • Peter Hau - Universität Regensburg, Klinik für Neurologie, Regensburg, Deutschland
  • Jörg Hense - Universität Duisburg-Essen, Westdeutsches Tumorzentrum (WTZ), Essen, Deutschland; Universitätsklinikum Essen, Klinik für Medizinische Onkologie, Essen, Deutschland
  • Christoph Kleinschnitz - Universitätsklinikum Essen, Klinik für Neurologie, Essen, Deutschland
  • Anca-Ligia Grosu - Universitätsklinikum Freiburg, Klinik für Radiologie, Freiburg, Deutschland
  • Martin Stuschke - Universität Duisburg-Essen, Westdeutsches Tumorzentrum (WTZ), Essen, Deutschland; Universitätsklinikum Essen, Klinik für Radiotherapie, Essen, Deutschland
  • Sied Kebir - Universitätsklinikum Essen, Klinische Neuroonkologie, Essen, Deutschland; University Duisburg-Essen, Westdeutsches Tumorzentrum (WTZ), Essen, Deutschland

Deutsche Gesellschaft für Neurochirurgie. 70. Jahrestagung der Deutschen Gesellschaft für Neurochirurgie (DGNC), Joint Meeting mit der Skandinavischen Gesellschaft für Neurochirurgie. Würzburg, 12.-15.05.2019. Düsseldorf: German Medical Science GMS Publishing House; 2019. DocP203

doi: 10.3205/19dgnc539, urn:nbn:de:0183-19dgnc5399

Published: May 8, 2019

© 2019 Glas et al.
This is an Open Access article distributed under the terms of the Creative Commons Attribution 4.0 License. See license information at http://creativecommons.org/licenses/by/4.0/.

Outline

Text

Objective: In newly diagnosed glioblastoma (ndGBM) patients therapy with Tumor Treating Fields (TTFields) in combination with adjuvant temozolomide (TMZ) demonstrated significantly increased survival in the EF-14 phase III trial, wherein TTFields treatment was initiated 4-7 weeks after completion of radiochemotherapy and was administered on average 3.8 months after tumor diagnosis. Preclinical data support that TTFields synergistically enhance efficacy of radiotherapy in GBM, presumably by inhibiting DNA damage repair in irradiated cells. The presented phase I/II trial will evaluate safety and feasibilty of TTFields initiated prior and concomitant to combined radiochemotherapy in ndGBM.

Methods: In total, 33 patients will be enrolled in this multicenter trial. Patients ≤70 years (study arm A) will be investigated separately from those over 70 (study arm B). In arm A, enrolment will begin with 7 patients and continue afterward up to 20 patients provided that treatment is well tolerated. Patients will be treated with postsurgical TTFields (2–4 weeks after surgery and 1–2 weeks prior radiotherapy) followed by TTFields concomitant to 6 weeks of radiotherapy (60 Gy in 30 fractions with 2 Gy per fraction).

In arm B, enrolment will begin with 6 patients and continue afterward up to 13 patients given that treatment is well tolerated. Patients will be treated with postsurgical TTFields (2–4 weeks after surgery and 1–2 weeks prior radiotherapy) followed by TTFields concomitant to 3 weeks of hypofractionated radiotherapy (40 Gy given at 2,67 Gy per fraction). In both study arms, TTFields treatment will continue seamlessly after radiotherapy completion to cover a duration of approx. 9 months from TTFields onset. In both study arms, concomitant and adjuvant chemotherapy will be administered according to institutional standards and interdisciplinary tumor conference. In case of tumor recurrence, TTFields re-challenge is permitted.

Results: Primary endpoints are safety and tolerance based on the frequency of pre-specified adverse events (treatment limiting toxicity, TLT). Secondary endpoints consist in particular of PFS, OS, radiologic response and frequency of adverse events. First experiences will be presented.

Conclusion: The objective is to demonstrate that the administration of TTFields therapy prior and concomitant to radiotherapy and adjuvant chemotherapy is feasible and safe. Moreover, first data obtained on efficacy (phase II) may lay the groundwork for a potential randomized phase III trial.