AzTrials
AzTrials

Metastatic CancerPhase 3NCT00002899

Adjuvant Radiation Therapy in Treating Patients With Brain Metastases

A Phase 3 study testing adjuvant therapy, radiation therapy and stereotactic radiosurgery in people with Metastatic Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 33 sites in 13 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Cancer
What is being tested?
adjuvant therapy, radiation therapy and stereotactic radiosurgery
Type of treatment
Surgery or procedure
How many people
340 participants
Where
33 sitesin 13 countries
Study dates
Nov 1996to Nov 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

33 sites in 13 countries.

33 sites in 13 countries

France7 sites

  • Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • Centre Hospitalier Regional et Universitaire de Lille

    Lille, 59037

  • Centre Leon Berard

    Lyon, 69008

  • Centre Antoine Lacassagne

    Nice, 06189

  • Centre Haute Energie

    Nice, 6000

  • CHU Pitie-Salpetriere

    Paris, 75651

  • Centre Eugene Marquis

    Rennes, 35042

Other trials in France

United Kingdom6 sites

  • Edinburgh Cancer Centre at Western General Hospital

    Edinburgh, Scotland, EH4 2XU

  • University College Hospital - London

    London, England, WC1E 6AU

  • Nottingham City Hospital NHS Trust

    Nottingham, England, NG5 1PB

  • Royal Preston Hospital

    Preston, England, PR2 9HT

  • Royal Marsden NHS Foundation Trust - Surrey

    Sutton, England, SM2 5PT

  • Southend University Hospital NHS Foundation Trust

    Westcliff-on-Sea, England, SS0 0RY

Other trials in United Kingdom

Italy5 sites

  • Ospedale Niguarda Ca'Granda

    Milan, 20162

  • Istituto Nazionale Neurologico Carlo Besta

    Milan, 20133

  • Ospedale Ostetrico Ginecologica Sant Anna

    Torino, 10126

  • Universita Degli Studi di Turin

    Torino, 10126

  • Azienda Sanitaria Ospedaliera Ordine Mauriziano

    Torino, 10128

Other trials in Italy

Germany4 sites

  • Medizinische Universitaetsklinik I at the University of Cologne

    Cologne, D-50924

  • Medizinische Klinik und Poliklinik III - Universitaetsklinikum Leipzig

    Leipzig, D-04103

  • Universitaetsklinikum Tuebingen

    Tübingen, D-72076

  • Heinrich-Braun-Krankenhaus Zwickau

    Zwickau, 08060

Other trials in Germany

Belgium3 sites

  • Academisch Ziekenhuis der Vrije Universiteit Brussel

    Brussels, 1090

  • U.Z. Gasthuisberg

    Leuven, B-3000

  • Algemeen Ziekenhuis Sint-Augustinus

    Wilrijk, 2610

Other trials in Belgium

Finland1 site

  • Helsinki University Central Hospital

    Helsinki, FIN-00029

Other trials in Finland

Israel1 site

  • Rambam Medical Center

    Haifa, 31096

Other trials in Israel

Latvia1 site

  • Paula Stradina Kliniskas Universitates Slimnica

    Riga, 1002

Other trials in Latvia

Netherlands1 site

  • Maastro Clinic - Locatie Maastricht

    Maastricht, NL-6229 ET

Other trials in Netherlands

Portugal1 site

  • Hospital Santa Maria

    Lisbon, 1699

Other trials in Portugal

Spain1 site

  • Institut Catala d'Oncologia - Hospital Duran i Reynals

    Barcelona, 08907

Other trials in Spain

Switzerland1 site

  • Oncology Institute of Southern Switzerland

    Bellinzona, CH-6500

Other trials in Switzerland

Turkey (Türkiye)1 site

  • Marmara University Hospital

    Istanbul, 81190

Other trials in Turkey (Türkiye)

About this study

Official title: 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.

Read the 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.

Being tested
adjuvant therapy, radiation therapy, stereotactic radiosurgery
Keywords
tumors metastatic to brain
Medical subject headings
Neoplasm Metastasis, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • adjuvant therapyProcedure or surgery

  • radiation therapyRadiation

  • stereotactic radiosurgeryRadiation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

  1. Overall survival as measured by Logrank at 8 weeks after completion of study treatment, and then every 3 months until death

  2. Progression-free survival as measured by Logrank 8 weeks after completion of study treatment, and then every 3 months until death

  3. Time to neurological progression as measured by Logrank 8 weeks after completion of study treatment, and then every 3 months until death

  4. Acute toxicity as measured by EORTC and RTOG scale 8 weeks after completion of study treatment, and then every 3 months until death

  5. 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

  6. 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startNov 1996
  3. Primary completionNov 2007

Why it stopped: Low accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
340 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002899
Sponsor's protocol ID
EORTC-22952-26001
Other IDs
EORTC-22952, EORTC-26001
Status last verified
Jun 2012
First submitted
1 Nov 1999
Last updated
2 Jul 2012
Results posted
No

Publications

  • 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.

    PubMed 21041710

  • 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.

    PubMed 21584645

  • 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.

    PubMed 30419088

  • 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.

    PubMed 28961826

  • 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.

    PubMed 23213105

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing adjuvant therapy, radiation therapy and stereotactic radiosurgery in people with Metastatic Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 33 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 2 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 33 sites in France, United Kingdom, Italy, Germany, Belgium and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Low accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary 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. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002899, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2012.

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