Adjuvant Radiation Therapy in Treating Patients With Brain Metastases

June 29, 2012 updated by: European Organisation for Research and Treatment of Cancer - EORTC

Phase III Trial on Convergent Beam Irradiation of Cerebral Metastases

RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Adjuvant radiation therapy may kill any remaining tumor cells following surgery or radiosurgery for brain metastases.

PURPOSE: This randomized phase III trial is studying surgery or radiosurgery alone to see how well it works compared to surgery or radiosurgery and whole-brain radiation therapy in treating brain metastases in patients with solid tumors.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

Primary

  • Investigate the efficacy and toxicity of adjuvant whole brain radiotherapy after prior surgical resection or radiosurgery of 1 to 3 brain metastases from solid tumor in patients with good performance status and controlled systemic cancer.

Secondary

  • Determine overall survival and progression-free survival of patients treated on this protocol.
  • Determine time to neurologic progression in patients treated on this protocol.
  • Determine quality of life of patients treated on this protocol.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating center, number of brain metastases (single vs multiple), type of primary tumor (stable systemic cancer vs synchronous or unknown primary), WHO performance status (0-1 vs 2), and treatment (prior surgical resection vs planned radiosurgery).

Patients who have undergone complete surgical resection are randomized to 1 of 2 treatment arms within 4 weeks after surgery.

  • Arm I: Patients undergo adjuvant whole brain radiotherapy (WBRT).
  • Arm II: Patients do not receive adjuvant radiotherapy. Patients planning to undergo radiosurgery are randomized to 1 of 2 treatment arms.
  • Arm III: Patients undergo radiosurgery followed by adjuvant WBRT within 4 weeks after surgery.
  • Arm IV: Patients undergo radiosurgery alone. Quality of life is assessed at baseline, at 8 weeks, and then every 3 months thereafter.

After completion if study treatment, patients are followed at 8 weeks and then every 3 months thereafter.

PROJECTED ACCRUAL: A total of 340 patients (85 per treatment arm) will be accrued for this study within 3.5 years.

Study Type

Interventional

Enrollment (Anticipated)

340

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

  • Belgium
      • Brussels, Belgium, 1090
        • Academisch Ziekenhuis der Vrije Universiteit Brussel
      • Leuven, Belgium, B-3000
        • U.Z. Gasthuisberg
      • Wilrijk, Belgium, 2610
        • Algemeen Ziekenhuis Sint-Augustinus
  • Finland
      • Helsinki, Finland, FIN-00029
        • Helsinki University Central Hospital
  • France
      • Besancon, France, 25030
        • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
      • Lille, France, 59037
        • Centre Hospitalier Regional et Universitaire de Lille
      • Lyon, France, 69008
        • Centre Leon Berard
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Nice, France, 6000
        • Centre Haute Energie
      • Paris, France, 75651
        • CHU Pitié-Salpêtrière
      • Rennes, France, 35042
        • Centre Eugène Marquis
  • Germany
      • Cologne, Germany, D-50924
        • Medizinische Universitaetsklinik I at the University of Cologne
      • Leipzig, Germany, D-04103
        • Medizinische Klinik und Poliklinik III - Universitaetsklinikum Leipzig
      • Tuebingen, Germany, D-72076
        • Universitaetsklinikum Tuebingen
      • Zwickau, Germany, 08060
        • Heinrich-Braun-Krankenhaus Zwickau
  • Israel
      • Haifa, Israel, 31096
        • Rambam Medical Center
  • Italy
      • Milan, Italy, 20162
        • Ospedale Niguarda Ca'Granda
      • Milano, Italy, 20133
        • Istituto Nazionale Neurologico Carlo Besta
      • Torino, Italy, 10126
        • Universita Degli Studi di Turin
      • Torino, Italy, 10126
        • Ospedale Ostetrico Ginecologica Sant Anna
      • Torino, Italy, 10128
        • Azienda Sanitaria Ospedaliera Ordine Mauriziano
  • Latvia
      • Riga, Latvia, 1002
        • Paula Stradina Kliniskas Universitates Slimnica
  • Netherlands
      • Maastricht, Netherlands, NL-6229 ET
        • Maastro Clinic - Locatie Maastricht
  • Portugal
      • Lisbon, Portugal, 1699
        • Hospital Santa Maria
  • Spain
      • Barcelona, Spain, 08907
        • Institut Català d'Oncologia - Hospital Duran i Reynals
  • Switzerland
      • Bellinzona, Switzerland, CH-6500
        • Oncology Institute of Southern Switzerland
  • Turkey
      • Istanbul, Turkey, 81190
        • Marmara University Hospital
  • United Kingdom
    • England
      • London, England, United Kingdom, WC1E 6AU
        • University College Hospital - London
      • Nottingham, England, United Kingdom, NG5 1PB
        • Nottingham City Hospital NHS Trust
      • Preston, England, United Kingdom, PR2 9HT
        • Royal Preston Hospital
      • Sutton, England, United Kingdom, SM2 5PT
        • Royal Marsden NHS Foundation Trust - Surrey
      • Westcliff-On-Sea, England, United Kingdom, SS0 0RY
        • Southend University Hospital NHS Foundation Trust
    • Scotland
      • Edinburgh, Scotland, United Kingdom, EH4 2XU
        • Edinburgh Cancer Centre at Western General Hospital

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

DISEASE CHARACTERISTICS:

  • Diagnosis of brain metastases from a histologically confirmed primary or metastatic extracranial tumor, meeting 1 of the following criteria:

    • Stable systemic cancer for the last 3 months (achieved by surgery, radiotherapy, chemotherapy, or hormonal therapy), defined as absence of symptomatic or radiological progression

    • Asymptomatic synchronous primary tumor (treatable by surgery, radiotherapy, chemotherapy, or hormonal therapy)

      • No metastases outside the CNS
    • Unknown primary tumor

  • Must have one to three brain lesions, confirmed by enhanced MRI prior to radiosurgery or surgery

    • No brain stem metastases
    • No leptomeningeal metastases
    • No brain metastases from small cell lung cancer, lymphoma, leukemia, myeloma, or germ cell tumors

  • Patients planning to undergo radiosurgery must meet the following criteria:

    • Largest diameter ≤ 3.5 cm for single metastasis
    • Largest diameter ≤ 2.5 cm for multiple metastases
    • Stereotactic biopsy required if not extracranial tumor (unknown primary tumor) OR extracranial diagnosis made more than 4 years previously
  • Prior neurosurgery patients must have undergone complete surgical resection
  • No recurrent brain metastases after prior surgery and/or radiosurgery and/or brain radiotherapy

PATIENT CHARACTERISTICS:

Age

  • 18 and over

Performance status

  • WHO 0-2 (may be assessed under steroid therapy)

Life expectancy

  • Not specified

Hematopoietic

  • Not specified

Hepatic

  • Not specified

Renal

  • Not specified

PRIOR CONCURRENT THERAPY:

Biologic therapy

  • Not specified

Chemotherapy

  • See Disease Characteristics
  • No concurrent chemotherapy during whole brain radiotherapy

Endocrine therapy

  • See Disease Characteristics

Radiotherapy

  • See Disease Characteristics

Surgery

  • See Disease Characteristics

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Survival with a WHO performance status 0-2 as measured by Logrank at 8 weeks after completion of study treatment, and then every 3 months until death

Secondary Outcome Measures

Outcome Measure
Overall survival as measured by Logrank at 8 weeks after completion of study treatment, and then every 3 months until death
Progression-free survival as measured by Logrank 8 weeks after completion of study treatment, and then every 3 months until death
Time to neurological progression as measured by Logrank 8 weeks after completion of study treatment, and then every 3 months until death
Acute toxicity as measured by EORTC and RTOG scale 8 weeks after completion of study treatment, and then every 3 months until death
Late toxicity as measured by Subjective, Objective, Management and Analytic/Late Effects on Normal Tissues (SOMA/LENT) scale 8 weeks after completion of study treatment, and then every 3 months until death
Quality of life as measured by QLQ-C30 and BN-25 8 weeks after completion of study treatment, and then every 3 months until death

Collaborators and Investigators

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

Sponsor

European Organisation for Research and Treatment of Cancer - EORTC

Investigators

  • Study Chair: Rolf-Peter Mueller, MD, Medizinische Universitaetsklinik I at the University of Cologne
  • Study Chair: Riccardo Soffietti, MD, Universita Degli Studi di Turin

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

November 1, 1996

Primary Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

November 1, 1999

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 2, 2012

Last Update Submitted That Met QC Criteria

June 29, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EORTC-22952-26001
  • EORTC-22952
  • EORTC-26001

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.

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