NCT01535209

Brief Summary

Adjuvant whole-brain radiation therapy (WBRT) after resection of single brain metastasis is considered as a standard associated with side effects leading to decreased neurocognitive function. The Investigators addressed the question whether stereotactic radiotherapy of the resection cavity impairs neurological status and/or cognitive functions in compare to adjuvant WBRT.

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
100

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2012

Typical duration for phase_3

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

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2012

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 17, 2012

Status Verified

February 1, 2012

Enrollment Period

2.9 years

First QC Date

February 14, 2012

Last Update Submit

February 16, 2012

Conditions

Brain Metastases

Keywords

Stereotactic radiotherapyWhole-brain radiotherapyResection cavity

Outcome Measures

Primary Outcomes (1)

  • Failure-free survival

    Time to decrease in MRC scale by 1 point or in MMSE by 3 points or neurologic death.

    5 months after radiotherapy

Secondary Outcomes (4)

  • Overall survival

    2 years

  • Quality of life assessment

    2 years

  • Time to distant intracranial progression

    2 years

  • Time to local progression

    2 years

Study Arms (2)

SBRT to resection cavity

EXPERIMENTAL

18Gy in 1 fraction for resection cavity \<2cm in maximum diameter, 15Gy in 1 fraction for resection cavity 2.1-3cm in maximum diameter, 15Gy in 1 fraction or 25 Gy in 5 fractions over 5 days for resection cavity 3.1-4cm in maximum diameter, 25 Gy in 5 fractions over 5 days for resection cavity \>4cm in maximum diameter

Radiation: stereotactic body radiotherapy (SBRT)

WBRT

ACTIVE COMPARATOR

30Gy in 10 fractions over 12 days to whole brain

Radiation: Whole-Brain Radiotherapy (WBRT)

Interventions

stereotactic body radiotherapy (SBRT)RADIATION

18Gy in 1 fraction for resection cavity \<2cm in maximum diameter, 15Gy in 1 fraction for resection cavity 2.1-3cm in maximum diameter, 15Gy in 1 fraction or 25 Gy in 5 fractions over 5 days for resection cavity 3.1-4cm in maximum diameter, 25 Gy in 5 fractions over 5 days for resection cavity \>4cm in maximum diameter

Also known as: stereotactic body radiotherapy
SBRT to resection cavity
Whole-Brain Radiotherapy (WBRT)RADIATION

10 x 3 Gy to whole brain

Also known as: whole brain irradiation, adjuvant cranial irradiation
WBRT

Eligibility Criteria

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

You may qualify if:

  • Patients with surgically removed histologically proven metastatic cancer
  • Subtotal or total resection of single brain metastasis
  • Presence of single brain metastasis in MRI
  • Karnofsky Performance Status ≥ 70
  • Life expectancy \> 6 months (minimal extracranial disease or availability of effective oncology treatment)
  • No previous history of cranial irradiation
  • Availability of MRI
  • Starting radiotherapy within six weeks after neurosurgery
  • Negative pregnancy test for woman
  • Written informed consent

You may not qualify if:

  • Dementia and central nervous system diseases leading to higher risk of radiation toxicity
  • Contraindications for MRI and/or no patient's tolerance and acceptance of cranial MRI
  • Altered level of consciousness
  • Histologically proven metastatic small cell lung cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M.Sklodowska-Curie Memorial Cancer Centre

Warsaw, 02-781, Poland

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Interventions

Radiosurgery

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

RadiotherapyTherapeuticsStereotaxic TechniquesNeurosurgical ProceduresSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Lucyna Kepka, Prof.

    M.Sklodowska-Curie Memorial Cancer Centre, Warsaw, Poland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wojciech Michalski, M.S.

CONTACT

+48226433909W.Michalski@coi.waw.pl

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2012

First Posted

February 17, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 17, 2012

Record last verified: 2012-02

Locations

PL(1)