Sector Irradiation Versus Whole Brain Irradiation for Brain Metastasis

Summary

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.

Conditions

• Metastatic Malignant Neoplasm to the Adult Brain

Interventions

RADIATION

sector irradiation

Gross Tumor Volume (GTV) is defined as the visible margin of the resection on post- operative MRI and planning- CT-scan. The Clinical Treatment Volume (CTV) is the same as the GTV plus a 5 mm margin The Planning Treatment Volume (PTV) includes the CTV plus a 1mm margin. A non-invasive immobilization is used for the planning CT and treatment delivery with an accuracy of ≤ 1mm. Treatment planning will conform to ICRU 50/62 rules for coverage of GTV, CTV and PTV. Additionally, organs at risk are delineated according to the ICRU 62 rules. Treatment with radiotherapy will start 2 to 3 weeks after surgery. The prescribed dose for the PTV is 30 Gy in 5 fractions. Isodose distributions will be calculated through the target in three planes. Dose volume histograms will be reported.

RADIATION

whole brain irradiation

For whole brain radiation the entire brain, the base of the skull and the meninges are included. Radiation is performed fractionated with 40 Gy. The caudal boundary of the radiation-target volume is between the 2. and the 3. cervical vertebra. The radiation is performed via two lateral, opposing and isocentric contra fields. The face/ventral skull is shielded with individual blocs or MLC. The used energy for the radiation fields should be between 6 and 16 MV. The specification point of the dose or the standardization point has to be chosen in that way that the point is in the middle of the target volume. The target volume is radiated within the tolerance range of 95% - 107 %. The maximum/minimum doses in the target volume and possible doses peaks are documented.

Sponsors & Collaborators

• Marcel Seiz-Rosenhagen MD, PD

  collaborator UNKNOWN

• Meinhard Nevinny-Stickel MD, Prof.

  collaborator UNKNOWN

• Christian F Freyschlag MD

  collaborator UNKNOWN

• Günther Stockhammer MD, Prof.

  collaborator UNKNOWN

• Bernhard Holzner MD, Doz

  collaborator UNKNOWN

• Johannes Giesinger Mag

  collaborator UNKNOWN

• Margarete Delazer MD, Prof.

  collaborator UNKNOWN

• Thomas Bodner MD, MSc

  collaborator UNKNOWN

• Claudius Thomé MD, Prof.

  collaborator UNKNOWN

• Medical University Innsbruck

  lead OTHER

Principal Investigators

• Marcel Seiz-Rosenhagen, MD, PD · Department of Neurosurgery, Medical University Innsbruck

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-04-30

Primary Completion

2016-04-30

Completion

2017-04-30

Countries

• Austria

Study Locations