Breast Cancer Clinical Trial
Official title:
Double-blind Randomized Multicenter Phase III Study Evaluation of the Efficacy of Hippocampal Avoidance on the Cognitive Toxicity of Whole-brain Radiation Therapy After Surgical Resection of Single Brain Metastasis of Breast Cancer.
The incidence of brain metastases (BM) in metastatic breast cancer is increasing, due to the
improvement in the control of systemic disease, and due to an improved detection through
imagery.
The treatment management of single BM remains controversial. Indeed, even though it is widely
accepted that local treatment increases the median survival time in patients having a good
prognostic status, the adding of "adjuvant" whole-brain radiation therapy (WBRT) is currently
subject to controversy, due to its potential toxicity. Yet, two randomized trials have
demonstrated a clear increase in intra-cerebral recurrence and in death from neurologic
origin in case of absence of "adjuvant" WBRT, without change in overall survival (but overall
survival was not a primary endpoint in any of these studies).
The data from literature on cognitive toxicity (CT) of WBRT on BM are scarce and sometimes
controversial. CT of WBRT affects the subcortical frontal functions. It is postulated that
the alteration of hippocampal neurogenesis (mainly due to inflammation process), situated in
the subgranular zone of the dentate gyrus, has an essential role in the development of these
brain dysfunctions.
It has been shown that the incidence of BM in the hippocampal region (hippocampus + 5mm
expansion) is low, in the range of 8,6%.
New irradiation techniques, in particular intensity-modulated radiotherapy associated with
rotational radiotherapy, allow to modulate the dose on an intra-cerebral structure, all the
while distributing an adapted dose to the remaining brain.
This prospective, randomized study, will compare, through a battery of neuropsychological
tests, the cognitive impact of WBRT of 40 Gy in 20 fractions with or without hippocampal
avoidance by intensity modulated radiotherapy, in patients presenting with a single operated
brain metastasis of breast cancer. If the hippocampal avoidance leads to a significant
improvement in cognitive function, this radiotherapy scheme could become the standard
postoperative treatment to be proposed to patients presenting the best prognostic factors.
This would allow to prevent long-term cognitive deficit, while preserving WBRT benefit on
intra-cerebral control.
Justification of evaluation criteria :
Principal criteria :
Evaluation criteria to assess cognitive toxicity have been selected on the basis of the
recommendations from C. Meyers and P. Brown, who propose an adapted test battery to evaluate
memory, verbal function, visual and motor coordination, and executive function. The selected
tests have been validated, also in French. They comprise HVLT-R (Hopkins Verbal Learning Test
Revised), COWAT (Controlled Oral Word Association Test), Grooved Pegboard test, TMT A and B
(Trailmaking tests A and B), and MMSE. The calculation of patient numbers was based on the
HVLT-R test, as memory is thought to be the most frequently affected domain.
The tests will be performed before treatment ("baseline" cognitive function), at 4 months and
at 12 months. In case of a missing answer to the evaluation tests, the reason(s) for not
answering will be noted.
Secondary criteria :
Quality of life : QLQ-C30, QLQ-BN20, ADL, IADL Intra-cerebral Progression-free survival (PFS)
Overall survival.
n/a
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