NCT01667640

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

August 7, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 17, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

April 29, 2015

Status Verified

April 1, 2015

Enrollment Period

4 years

First QC Date

August 7, 2012

Last Update Submit

April 28, 2015

Conditions

Metastatic Malignant Neoplasm to the Adult Brain

Keywords

Brain metastasesradiationsectorsingularsolitaryneurocognition

Outcome Measures

Primary Outcomes (1)

  • local tumor control

    time from date of randomization until the date of first documented progression, assessed up to 36 months

Secondary Outcomes (7)

  • distant brain metastasis

    Time from date of randomization until the date of first documented progression elsewhere than the resection cavity, assessed at 3, 6, 12 and 36 months

  • time to clinical deterioration

    Time from randomization to clinical deterioration, assessed by neurosurgeon in regular follow up visits at 3, 6, 12 and 36 months

  • local progression free survival

    Time from randomization to the first documented tumor progressions in the resection cavity borders, assessed up to 36 months

  • quality of life

    3, 6, 12 and 36 months

  • neurocognitive functions

    3, 6, 12 and 36 months postoperative

  • +2 more secondary outcomes

Study Arms (2)

whole brain irradiation

ACTIVE COMPARATOR

whole brain irradiation with 40 Gy, with fixation mask, radiation of the entire brain, skull base and meninges

Radiation: whole brain irradiation

sector irradiation

EXPERIMENTAL

irradiation of the resection margin plus 5 mm safety margin with 30 Gy in 5 fractions

Radiation: sector irradiation

Interventions

sector irradiationRADIATION

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.

sector irradiation
whole brain irradiationRADIATION

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.

whole brain irradiation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Solitary/singular brain metastasis
  • Karnofsky Performance Index \> 60%
  • Stable extracranial disease /CUP
  • Informed consent

You may not qualify if:

  • Small cell lung cancer
  • Squamous cell lung cancer
  • HER2-negative breast cancer
  • Deep-seated location (e.g. basal ganglia)
  • Expected surgery related neurological deficit
  • Tumor diameter \< 3cm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of neurosurgery - Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Related Publications (1)

  • Kerschbaumer J, Pinggera D, Holzner B, Delazer M, Bodner T, Karner E, Dostal L, Kvitsaridze I, Minasch D, Thome C, Seiz-Rosenhagen M, Nevinny-Stickel M, Freyschlag CF. Sector Irradiation vs. Whole Brain Irradiation After Resection of Singular Brain Metastasis-A Prospective Randomized Monocentric Trial. Front Oncol. 2020 Nov 24;10:591884. doi: 10.3389/fonc.2020.591884. eCollection 2020.

    PMID: 33330076DERIVED

Related Links

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Marcel Seiz-Rosenhagen, MD, PD

    Department of Neurosurgery, Medical University Innsbruck

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Johannes Kerschbaumer, MD

CONTACT

+43-512-504-82848johannes.kerschbaumer@uki.at

Christian F Freyschlag, MD

CONTACT

+43-512-504-82595christian.freyschlag@uki.at

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 7, 2012

First Posted

August 17, 2012

Study Start

April 1, 2012

Primary Completion

April 1, 2016

Study Completion

April 1, 2017

Last Updated

April 29, 2015

Record last verified: 2015-04

Locations

AU(1)