German Brain Cancer Study Stopped Early Due to Slow Patient Recruitment

May 26, 2019 | Brain Metastases, Hippocampal Sparing, Melanoma, Tomotherapy

A prominent group of German investigators sought a noble study for a horrific condition. Patients with multiple brain metastases (BMs) from malignant melanoma face a dire situation. Recent developments in radiation techniques allow simultaneous integrated boost (SIB) concepts while sparing organs at risk. Data on conventional versus dose-escalated radiation approaches in multiple BMs from malignant melanoma are warranted.

The Study

The German team set up a prospective, single-center, randomized two-armed study. Patients with multiple BMs from malignant melanoma were treated either with conventional whole-brain radiotherapy (WBRT) applying 30 Gy in 10 fractions (standard arm) or helical tomotherapy applying 30 Gy to the whole brain with an integrated boost to metastases of 50 Gy in 10 fractions and sparing of the hippocampus (HA-WBRT, experimental arm).

The primary endpoint was treatment -related toxicity, while secondary endpoints were imaging response, intracerebral progression-free survival (PFS), overall survival (OS) and quality of life.

Results

As reported in DovePress, the study was stopped early due to slow patient recruitment.  7 patients were enrolled (standard arm n =3, experimental arm n = 4), and were followed -up for a median time of 5 months between 2013 and 2017. All patients were treated according to the protocol. The median OS, intracerebral PFS and follow-up time were 5 months, 2 months and 5 months respectively. The local control in every individual BM was significantly longer in the experimental versus the standard arm. No patient developed radiation-related high-grade toxicities

Lead Research/Investigators

Hank Hauswald

Denise Bernhardt

David Krug

Sonja Katayama

Gregor Habl

Justo Lorenzo Bermejo

JürgenDebus

Florian  Sterzing

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