Metastatic Malignant Neoplasm to the Adult Brain Clinical Trial
Official title:
Sector Irradiation Versus Whole Brain Irradiation After Resection of Singular or Solitary Brain Metastasis - a Prospective Randomized Monocentric Trial
Microneurosurgical resection of intracerebral metastases leads to prolonged survival and
relief of symptoms in selected patients.
To minimize the risk of intracranial recurrence whole brain irradiation has been established
as standard adjuvant treatment in those patients. Sector irradiation resembles a brain -
tissue - sparing method by focusing the irradiation in the area of the tumor bed and a
surrounding 1mm security margin.
The aim of this study is to investigate whether adjuvant "sector""-irradiation following
microsurgical resection is equal to adjuvant whole brain irradiation in terms of local
control and superior to in terms of quality of life and neurocognitive deficits in a
prospective randomized trial.
Microneurosurgical resection of intracerebral metastases leads to prolonged survival and
relief of symptoms in selected patients. Traditionally whole-brain irradiation is the
treatment of choice following surgical resection. Whole brain irradiation has been the
standard approach to minimize the risk of intracranial recurrence following resection of
brain metastases. Almost 2 decades ago, Patchell et al. established the superiority of
resection of solitary metastases followed by whole brain irradiation compared with whole
brain irradiation alone with regard to survival, local control, and length of functional
independence. A following study by the same group failed to show a survival advantage for
the addition of whole brain irradiation compared to surgical resection alone in patients
with a solitary intracranial metastasis, although the likelihood of local and distant
recurrence and death from neurological causes were significantly reduced by whole brain
irradiation. Due to potential delayed neurocognitive effects associated with whole brain
irradiation, investigators have evaluated the use of partial brain irradiation in the form
of stereotactic radiosurgery instead of whole brain irradiation after resection of brain
metastases. They showed that despite whole brain irradiation means superior control of brain
recurrence in sites other than the resection bed, stereotactic radiosurgery after resection
resulted in equivalent survival times and neurological preservation. In a retrospective
series of 52 patients Karlovits et al. could show that stereotactic radiosurgery following
surgical resection leads to equal local control compared to standard whole brain
irradiation.
Study objective
The aim of this study is to investigate whether adjuvant "sector" -irradiation following
microsurgical resection is equal to adjuvant whole brain irradiation in terms of local
control and superior to in terms of quality of life and neurocognitive deficits in a
prospective randomized trial.
Hypothesis
1. Sector irradiation is equal to whole-brain irradiation in local tumor control after 3,
6, 12 and 36 months and
2. Sector irradiation" is superior to whole-brain irradiation in terms of quality of life
and neurocognitive function
Patients and Methods
Patients with a single brain metastasis amenable to surgical resection fulfilling the
inclusion criteria will be consecutively enrolled in this study. After microsurgical
complete resection documented by early postoperative MRI within 72 hours and histological
proven brain metastasis patients will be randomized in arm A or B. Radiotherapy will start
after 14th postoperative day within 3 weeks postoperatively. Study arm A means postoperative
sector irradiation (30Gy), study arm B includes standard whole brain radiotherapy (40Gy).
Follow up MRI will be every 3 months. Neurocognitive evaluation will be performed before
radiotherapy and 6 and 12 months postoperatively. In case of local recurrence or developing
further metastases a cross over to whole brain radiotherapy or focal irradiation is
possible.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT01353573 -
Robotic Compared to Fixed Gantry Radiosurgery for Brain Metastases
|
Phase 3 |