Adjuvant Radiation Therapy in Treating Patients With Brain Metastases

NCT00002899 | Terminated Phase 3

• 3 other identifiers: EORTC-22952-26001EORTC-22952EORTC-26001
• Study Type: interventional
• Target: 340
• Locations: 13 countries
• Sites: 33

Brief Summary

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.

Conditions

Metastatic Cancer

Keywords

tumors metastatic to brain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Interventions

adjuvant therapy PROCEDURE

radiation therapy RADIATION

stereotactic radiosurgery RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (33)

Academisch Ziekenhuis der Vrije Universiteit Brussel

Brussels, 1090, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Algemeen Ziekenhuis Sint-Augustinus

Wilrijk, 2610, Belgium

Location

Helsinki University Central Hospital

Helsinki, FIN-00029, Finland

Location

Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

Besançon, 25030, France

Location

Centre Hospitalier Regional et Universitaire de Lille

Lille, 59037, France

Location

Centre Leon Berard

Lyon, 69008, France

Location

Centre Antoine Lacassagne

Nice, 06189, France

Location

Centre Haute Energie

Nice, 6000, France

Location

CHU Pitie-Salpetriere

Paris, 75651, France

Location

Centre Eugene Marquis

Rennes, 35042, France

Location

Medizinische Universitaetsklinik I at the University of Cologne

Cologne, D-50924, Germany

Location

Medizinische Klinik und Poliklinik III - Universitaetsklinikum Leipzig

Leipzig, D-04103, Germany

Location

Universitaetsklinikum Tuebingen

Tübingen, D-72076, Germany

Location

Heinrich-Braun-Krankenhaus Zwickau

Zwickau, 08060, Germany

Location

Rambam Medical Center

Haifa, 31096, Israel

Location

Ospedale Niguarda Ca'Granda

Milan, 20162, Italy

Location

Istituto Nazionale Neurologico Carlo Besta

Milan, 20133, Italy

Location

Ospedale Ostetrico Ginecologica Sant Anna

Torino, 10126, Italy

Location

Universita Degli Studi di Turin

Torino, 10126, Italy

Location

Azienda Sanitaria Ospedaliera Ordine Mauriziano

Torino, 10128, Italy

Location

Paula Stradina Kliniskas Universitates Slimnica

Riga, 1002, Latvia

Location

Maastro Clinic - Locatie Maastricht

Maastricht, NL-6229 ET, Netherlands

Location

Hospital Santa Maria

Lisbon, 1699, Portugal

Location

Institut Catala d'Oncologia - Hospital Duran i Reynals

Barcelona, 08907, Spain

Location

Oncology Institute of Southern Switzerland

Bellinzona, CH-6500, Switzerland

Location

Marmara University Hospital

Istanbul, 81190, Turkey (Türkiye)

Location

University College Hospital - London

London, England, WC1E 6AU, United Kingdom

Location

Nottingham City Hospital NHS Trust

Nottingham, England, NG5 1PB, United Kingdom

Location

Royal Preston Hospital

Preston, England, PR2 9HT, United Kingdom

Location

Royal Marsden NHS Foundation Trust - Surrey

Sutton, England, SM2 5PT, United Kingdom

Location

Southend University Hospital NHS Foundation Trust

Westcliff-on-Sea, England, SS0 0RY, United Kingdom

Location

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 21041710 RESULT

• 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.

  PMID: 21584645 RESULT

• 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.

  PMID: 30419088 DERIVED

• 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.

  PMID: 28961826 DERIVED

• 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.

  PMID: 23213105 DERIVED

MeSH Terms

Conditions

Neoplasm Metastasis; Brain Neoplasms

Interventions

Chemotherapy, Adjuvant; Radiotherapy; Radiosurgery

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Rolf-Peter Mueller, MD

  Medizinische Universitaetsklinik I at the University of Cologne

  STUDY CHAIR

• Riccardo Soffietti, MD

  Universita Degli Studi di Turin

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: November 1, 1996
• Primary Completion: November 1, 2007
• Last Updated: July 2, 2012

Record last verified: 2012-06

Locations

GB (6); CH (1); PT (1); FR (7); IT (5); DE (4); IL (1); BE (3); LA (1); NL (1); FI (1); ES (1); TU (1)