Stereotactic Radiotherapy of Resection Cavity For Single Brain Metastasis Versus Whole-Brain Radiotherapy After Resection

February 16, 2012 updated by: Maria Sklodowska-Curie National Research Institute of Oncology

Phase 3 Study of Stereotactic Radiotherapy of the Postoperative Resection Cavity Versus Whole-Brain Irradiation After Surgical Resection of Single Brain Metastasis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients with surgically removed single brain metastasis are randomly allocated to control or experimental arm. Before treatment the MRC Neurological Status Scale is used for assessing neurological status, the EORTC QLQ-C30 and QLQ-BN20 for quality of life and Mini-Mental State Examination to assess cognitive functioning. The control group receive 30Gy in 10 fractions of 3Gy over 12 days to the whole brain. The patients in the experimental arm are treated with stereotactic radiotherapy to the resection cavity. The dose to the tumor bed is 15-18Gy in one fraction or 25Gy in 5 fractions. The study hypothesis is that the difference in the 5-months failure free survival rate isn't higher than 25% in experimental arm compared to control arm.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 02-781
        • Recruiting
        • M.Sklodowska-Curie Memorial Cancer Centre
        • Contact:
        • Principal Investigator:
          • Lucyna Kepka, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SBRT to resection cavity
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)
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
Other Names:
  • stereotactic body radiotherapy
Active Comparator: WBRT
30Gy in 10 fractions over 12 days to whole brain
Radiation: Whole-Brain Radiotherapy (WBRT)
10 x 3 Gy to whole brain
Other Names:
  • whole brain irradiation
  • adjuvant cranial irradiation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure-free survival
Time Frame: 5 months after radiotherapy
Time to decrease in MRC scale by 1 point or in MMSE by 3 points or neurologic death.
5 months after radiotherapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: 2 years
2 years
Quality of life assessment
Time Frame: 2 years
2 years
Time to distant intracranial progression
Time Frame: 2 years
2 years
Time to local progression
Time Frame: 2 years
Time to progression in the irradiated cavity
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology

Collaborators

Lower Silesian Oncology Center
Copernicus Memorial Hospital
Prof. Franciszek Lukaszczyk Memorial Oncology Center

Investigators

  • Principal Investigator: Lucyna Kepka, Prof., M.Sklodowska-Curie Memorial Cancer Centre, Warsaw, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

February 14, 2012

First Submitted That Met QC Criteria

February 16, 2012

First Posted (Estimate)

February 17, 2012

Study Record Updates

Last Update Posted (Estimate)

February 17, 2012

Last Update Submitted That Met QC Criteria

February 16, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAVITY

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Brain Metastases

Clinical Trials on stereotactic body radiotherapy (SBRT)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe