Back to resultsAdjuvant Radiation Therapy in Treating Patients With Brain Metastases
Primary Purpose
Metastatic Cancer
Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
adjuvant therapy
radiation therapy
stereotactic radiosurgery
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Cancer focused on measuring tumors metastatic to brain
Eligibility Criteria
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
Sites / Locations
- Academisch Ziekenhuis der Vrije Universiteit Brussel
- U.Z. Gasthuisberg
- Algemeen Ziekenhuis Sint-Augustinus
- Helsinki University Central Hospital
- Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
- Centre Hospitalier Regional et Universitaire de Lille
- Centre Leon Berard
- Centre Antoine Lacassagne
- Centre Haute Energie
- CHU Pitie-Salpetriere
- Centre Eugene Marquis
- Medizinische Universitaetsklinik I at the University of Cologne
- Medizinische Klinik und Poliklinik III - Universitaetsklinikum Leipzig
- Universitaetsklinikum Tuebingen
- Heinrich-Braun-Krankenhaus Zwickau
- Rambam Medical Center
- Istituto Nazionale Neurologico Carlo Besta
- Ospedale Niguarda Ca'Granda
- Ospedale Ostetrico Ginecologica Sant Anna
- Universita Degli Studi di Turin
- Azienda Sanitaria Ospedaliera Ordine Mauriziano
- Paula Stradina Kliniskas Universitates Slimnica
- Maastro Clinic - Locatie Maastricht
- Hospital Santa Maria
- Institut Catala d'Oncologia - Hospital Duran i Reynals
- Oncology Institute of Southern Switzerland
- Marmara University Hospital
- University College Hospital - London
- Nottingham City Hospital NHS Trust
- Royal Preston Hospital
- Royal Marsden NHS Foundation Trust - Surrey
- Southend University Hospital NHS Foundation Trust
- Edinburgh Cancer Centre at Western General Hospital
Outcomes
Primary Outcome Measures
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
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
Full Information
NCT ID
NCT00002899
First Posted
November 1, 1999
Last Updated
June 29, 2012
Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
1. Study Identification
Unique Protocol Identification Number
NCT00002899
Brief Title
Adjuvant Radiation Therapy in Treating Patients With Brain Metastases
Official Title
Phase III Trial on Convergent Beam Irradiation of Cerebral Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Terminated
Why Stopped
Low accrual
Study Start Date
November 1996 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Organisation for Research and Treatment of Cancer - EORTC
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer
Keywords
tumors metastatic to brain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
Enrollment
340 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Type
Radiation
Intervention Name(s)
stereotactic radiosurgery
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Overall survival as measured by Logrank at 8 weeks after completion of study treatment, and then every 3 months until death
Title
Progression-free survival as measured by Logrank 8 weeks after completion of study treatment, and then every 3 months until death
Title
Time to neurological progression as measured by Logrank 8 weeks after completion of study treatment, and then every 3 months until death
Title
Acute toxicity as measured by EORTC and RTOG scale 8 weeks after completion of study treatment, and then every 3 months until death
Title
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
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolf-Peter Mueller, MD
Organizational Affiliation
Medizinische Universitaetsklinik I at the University of Cologne
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Riccardo Soffietti, MD
Organizational Affiliation
Universita Degli Studi di Turin
Official's Role
Study Chair
Facility Information:
Facility Name
Academisch Ziekenhuis der Vrije Universiteit Brussel
City
Brussels
ZIP/Postal Code
1090
Country
Belgium
Facility Name
U.Z. Gasthuisberg
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
Algemeen Ziekenhuis Sint-Augustinus
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
Facility Name
Helsinki University Central Hospital
City
Helsinki
ZIP/Postal Code
FIN-00029
Country
Finland
Facility Name
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
City
Besancon
ZIP/Postal Code
25030
Country
France
Facility Name
Centre Hospitalier Regional et Universitaire de Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Leon Berard
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Centre Antoine Lacassagne
City
Nice
ZIP/Postal Code
06189
Country
France
Facility Name
Centre Haute Energie
City
Nice
ZIP/Postal Code
6000
Country
France
Facility Name
CHU Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Centre Eugene Marquis
City
Rennes
ZIP/Postal Code
35042
Country
France
Facility Name
Medizinische Universitaetsklinik I at the University of Cologne
City
Cologne
ZIP/Postal Code
D-50924
Country
Germany
Facility Name
Medizinische Klinik und Poliklinik III - Universitaetsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
D-04103
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Heinrich-Braun-Krankenhaus Zwickau
City
Zwickau
ZIP/Postal Code
08060
Country
Germany
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Istituto Nazionale Neurologico Carlo Besta
City
Milano
ZIP/Postal Code
20133
Country
Italy
Facility Name
Ospedale Niguarda Ca'Granda
City
Milan
ZIP/Postal Code
20162
Country
Italy
Facility Name
Ospedale Ostetrico Ginecologica Sant Anna
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Universita Degli Studi di Turin
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Azienda Sanitaria Ospedaliera Ordine Mauriziano
City
Torino
ZIP/Postal Code
10128
Country
Italy
Facility Name
Paula Stradina Kliniskas Universitates Slimnica
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Facility Name
Maastro Clinic - Locatie Maastricht
City
Maastricht
ZIP/Postal Code
NL-6229 ET
Country
Netherlands
Facility Name
Hospital Santa Maria
City
Lisbon
ZIP/Postal Code
1699
Country
Portugal
Facility Name
Institut Catala d'Oncologia - Hospital Duran i Reynals
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Oncology Institute of Southern Switzerland
City
Bellinzona
ZIP/Postal Code
CH-6500
Country
Switzerland
Facility Name
Marmara University Hospital
City
Istanbul
ZIP/Postal Code
81190
Country
Turkey
Facility Name
University College Hospital - London
City
London
State/Province
England
ZIP/Postal Code
WC1E 6AU
Country
United Kingdom
Facility Name
Nottingham City Hospital NHS Trust
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Royal Preston Hospital
City
Preston
State/Province
England
ZIP/Postal Code
PR2 9HT
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust - Surrey
City
Sutton
State/Province
England
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
Southend University Hospital NHS Foundation Trust
City
Westcliff-On-Sea
State/Province
England
ZIP/Postal Code
SS0 0RY
Country
United Kingdom
Facility Name
Edinburgh Cancer Centre at Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
21041710
Citation
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.
Results Reference
result
PubMed Identifier
21584645
Citation
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.
Results Reference
result
PubMed Identifier
30419088
Citation
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.
Results Reference
derived
PubMed Identifier
28961826
Citation
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.
Results Reference
derived
PubMed Identifier
23213105
Citation
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.
Results Reference
derived
Learn more about this trial
Adjuvant Radiation Therapy in Treating Patients With Brain Metastases
We'll reach out to this number within 24 hrs