Adjuvant Radiation Therapy in Treating Patients With Brain Metastases
NCT ID: NCT00002899
Last Updated: 2012-07-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
340 participants
INTERVENTIONAL
1996-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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adjuvant therapy
radiation therapy
stereotactic radiosurgery
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Rolf-Peter Mueller, MD
Role: STUDY_CHAIR
Medizinische Universitaetsklinik I at the University of Cologne
Riccardo Soffietti, MD
Role: STUDY_CHAIR
Universita Degli Studi di Turin
Locations
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Academisch Ziekenhuis der Vrije Universiteit Brussel
Brussels, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Algemeen Ziekenhuis Sint-Augustinus
Wilrijk, , Belgium
Helsinki University Central Hospital
Helsinki, , Finland
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
Besançon, , France
Centre Hospitalier Regional et Universitaire de Lille
Lille, , France
Centre Leon Berard
Lyon, , France
Centre Antoine Lacassagne
Nice, , France
Centre Haute Energie
Nice, , France
CHU Pitie-Salpetriere
Paris, , France
Centre Eugene Marquis
Rennes, , France
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, , Germany
Medizinische Klinik und Poliklinik III - Universitaetsklinikum Leipzig
Leipzig, , Germany
Universitaetsklinikum Tuebingen
Tübingen, , Germany
Heinrich-Braun-Krankenhaus Zwickau
Zwickau, , Germany
Rambam Medical Center
Haifa, , Israel
Ospedale Niguarda Ca'Granda
Milan, , Italy
Istituto Nazionale Neurologico Carlo Besta
Milan, , Italy
Ospedale Ostetrico Ginecologica Sant Anna
Torino, , Italy
Universita Degli Studi di Turin
Torino, , Italy
Azienda Sanitaria Ospedaliera Ordine Mauriziano
Torino, , Italy
Paula Stradina Kliniskas Universitates Slimnica
Riga, , Latvia
Maastro Clinic - Locatie Maastricht
Maastricht, , Netherlands
Hospital Santa Maria
Lisbon, , Portugal
Institut Catala d'Oncologia - Hospital Duran i Reynals
Barcelona, , Spain
Oncology Institute of Southern Switzerland
Bellinzona, , Switzerland
Marmara University Hospital
Istanbul, , Turkey (Türkiye)
University College Hospital - London
London, England, United Kingdom
Nottingham City Hospital NHS Trust
Nottingham, England, United Kingdom
Royal Preston Hospital
Preston, England, United Kingdom
Royal Marsden NHS Foundation Trust - Surrey
Sutton, England, United Kingdom
Southend University Hospital NHS Foundation Trust
Westcliff-on-Sea, England, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, United Kingdom
Countries
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References
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Kocher M, Soffietti R, Abacioglu U, Villa S, Fauchon F, Baumert BG, Fariselli L, Tzuk-Shina T, Kortmann RD, Carrie C, Ben Hassel M, Kouri M, Valeinis E, van den Berge D, Collette S, Collette L, Mueller RP. Adjuvant whole-brain radiotherapy versus observation after radiosurgery or surgical resection of one to three cerebral metastases: results of the EORTC 22952-26001 study. J Clin Oncol. 2011 Jan 10;29(2):134-41. doi: 10.1200/JCO.2010.30.1655. Epub 2010 Nov 1.
Mekhail T, Sombeck M, Sollaccio R. Adjuvant whole-brain radiotherapy versus observation after radiosurgery or surgical resection of one to three cerebral metastases: results of the EORTC 22952-26001 study. Curr Oncol Rep. 2011 Aug;13(4):255-8. doi: 10.1007/s11912-011-0180-1. No abstract available.
Churilla TM, Chowdhury IH, Handorf E, Collette L, Collette S, Dong Y, Alexander BM, Kocher M, Soffietti R, Claus EB, Weiss SE. Comparison of Local Control of Brain Metastases With Stereotactic Radiosurgery vs Surgical Resection: A Secondary Analysis of a Randomized Clinical Trial. JAMA Oncol. 2019 Feb 1;5(2):243-247. doi: 10.1001/jamaoncol.2018.4610.
Churilla TM, Handorf E, Collette S, Collette L, Dong Y, Aizer AA, Kocher M, Soffietti R, Alexander BM, Weiss SE. Whole brain radiotherapy after stereotactic radiosurgery or surgical resection among patients with one to three brain metastases and favorable prognoses: a secondary analysis of EORTC 22952-26001. Ann Oncol. 2017 Oct 1;28(10):2588-2594. doi: 10.1093/annonc/mdx332.
Soffietti R, Kocher M, Abacioglu UM, Villa S, Fauchon F, Baumert BG, Fariselli L, Tzuk-Shina T, Kortmann RD, Carrie C, Ben Hassel M, Kouri M, Valeinis E, van den Berge D, Mueller RP, Tridello G, Collette L, Bottomley A. A European Organisation for Research and Treatment of Cancer phase III trial of adjuvant whole-brain radiotherapy versus observation in patients with one to three brain metastases from solid tumors after surgical resection or radiosurgery: quality-of-life results. J Clin Oncol. 2013 Jan 1;31(1):65-72. doi: 10.1200/JCO.2011.41.0639. Epub 2012 Dec 3.
Other Identifiers
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EORTC-22952
Identifier Type: -
Identifier Source: secondary_id
EORTC-26001
Identifier Type: -
Identifier Source: secondary_id
EORTC-22952-26001
Identifier Type: -
Identifier Source: org_study_id
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