Adjuvant stereotactic fractionated radiotherapy to the resection cavity in recurrent glioblastoma - the GlioCave study (NOA 17 - ARO 2016/3 - DKTK ROG trial)

Christoph Straube, Hagen Scherb, Jens Gempt, Jan Kirschke, Claus Zimmer, Friederike Schmidt-Graf, Bernhard Meyer, Stephanie E Combs, Christoph Straube, Hagen Scherb, Jens Gempt, Jan Kirschke, Claus Zimmer, Friederike Schmidt-Graf, Bernhard Meyer, Stephanie E Combs

Abstract

Background: Glioblastoma relapses in the vast majority of cases within 1 year. Maximum safe resection of the recurrent glioblastoma can be offered in some cases. Re-irradiation has been established for the treatment of recurrent glioblastoma, too. In both cases, adjuvant treatment, mostly using temozolomide, can improve PFS and OS after these interventions. However, combining gross tumor resection and adjuvant re-radiotherapy to the resection cavity has not been tested so far.

Methods/design: In the multicenter two-armed randomized Phase II GlioCave Study, fractionated stereotactic radiotherapy to the resection cavity, after gross tumor resection of recurrent glioblastoma, will be compared to observation. Depending on the size of the target volume, a total dose of 46 Gy in 2 Gy per fraction or a total dose if 36 Gy in 3 Gy per fraction will be applied. Progression free survival will be the primary endpoint of the study.

Discussion: Adjuvant treatment after gross tumor resection of recurrent glioblastoma is currently deemed to be limited to chemotherapy. However, re-irradiation has proven safety and tolerability in the treatment of macroscopic disease. Performing re-irradiation as an adjuvant measure after gross tumor resection has not been tested so far. The GlioCave Study will investigate the efficacy and the safety profile of this approach.

Trial registration: The trial was prospectively registered at clinicaltrials.gov ( NCT02715297 , registration date February 29th, 2016). The protocol presented hereby refers to the version 1.2 of the protocol (January 11th, 2017).

Keywords: Glioblastoma; Gross total resection; NOA; PFS; Randomized trial; Re-irradiation; Recurrence.

Conflict of interest statement

Ethics approval and consent to participate

A positive vote from the local ethical committee of the technical university of Munich, Germany (continuous registration code 525/15 S) was obtained.

The protocol received a positive vote from the “Unabhängiges Expertengremium der DEGRO”. By that, no further review is necessary.

All participants willed to participate into the trial have to give their written informed consent prior to inclusion into the GlioCave / NOA-17 trial. The informed consent includes also the permission for publication of anonymized patient data.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow chart of the GlioCave/NOA-17-Trial

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