Back to resultsA Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma.
Primary Purpose
Sarcoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Standard chemotherapy
bevacizumab [Avastin]
Sponsored by
About this trial
This is an interventional treatment trial for Sarcoma
Eligibility Criteria
Inclusion Criteria:
- childhood and adolescent patients aged >/=6 months to 18 years of age
- metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma
- adequate bone marrow function
- adequate renal and liver function
- adequate blood clotting
Exclusion Criteria:
- previous malignant tumors
- tumor invading major blood vessels
- prior systemic anti-tumor treatment
Sites / Locations
- Hôpital Enfants Reine Fabiola
- Cliniques Universitaires St-Luc
- UZ Gent
- Instituto Nacional do Cancer - INCA
- Clinica de Oncologia de Porto Alegre - CliniOnco
- Hospital de Cancer de Barretos
- Instituto de Oncologia Pediatrica
- ITACI - Instituto de Tratamento do Cancer Infantil
- Hospital Santa Marcelina
- Hospital For Sick Children
- Pavillion Chul-Chuq
- Hospital Luis Calvo Mackenna; Oncologia
- Fakultni nemocnice Brno
- Fakultni nemocnice v Motole
- CHU Bordeaux; Unite Onco-Hematologie Pediatrique
- Centre Oscar Lambret; Service de Pediatrie
- Centre Leon Berard; Pediatrie
- Hopital Timone Enfants; Onco Pediatrie
- Chr De Nantes; Service D'oncologie Pediatrique
- Institut Curie; Oncologie Medicale
- CHU Hopital Sud; Service d'Hematologie Pediatrique
- Hopital Des Enfants; Service d Hemato-Oncologie
- CHU Hopital d Enfants; Centre hospitalier Universitaire Nancy
- Institut Gustave Roussy; Service Pediatrique
- University Hospital Essen; Department of Pediatric Oncology
- Universitaetsklinikum Freiburg - PS; Partnersite - Onkologie
- Universitatsklinikum Munster; Padiatrische Hamatologie und Onkologie
- Soroka Medical Center
- Rambam Health Care Campus; Pediatric Hematology Oncology Department
- Schneider Children's Medical Center
- Tel Aviv Sourasky MC, Dana Children's Hospital; Pediatric Hemato-Oncology Clinic
- Ospedale Pediatrico Bambino Gesu
- Istituto Gaslini Ospedale Pediatrico; Dipartimento di Oncoematologia pediatrica
- Istituto Nazionale Tumori di Milano; S.C. Oncologia Pediatrica
- Dipartimento di Scienze Pediatriche Adolescenza; Osp. Infantile Regina Margherita
- U.O.A University Onco-Ematologia Pedicatria; Azienda Ospedaliera A.Meyer
- Azienda Ospedaliera di Padova; Clinica di Onco-ematologia pediatrica
- Emma Kinderziekenhuis; Dept of Pediatric Oncology
- Erasmus Mc/Sophia's Childrens Hospital; Dept. of Pediatric Oncology
- Prinses Maxima Centrum
- Uniwersytet Medyczny W Lublinie; Klinika Hematologii i Onkologii Dzieciecej
- Instytut Pomnik-Centrum Zdrowia Dziecka; Klinika Onkologii
- Center for Children's Hematology, Oncology and Immunology
- Saint-Petersburg SHI City Clinical Hospital #31
- Hospital de Cruces
- Hospital Universitari Vall d'Hebron; Servicio de Nefrologia
- Hospital Infantil Universitario Nino Jesus
- Hospital Regional Universitario Carlos Haya;Servicio Oncologia Pediatrica
- Hospital Universitario Virgen del Rocio; Servicio de Onco-Hematologia Pediatrica
- Hospital Universitario La Fe
- Birmingham Childrens Hospital; Oncology Dept
- Bristol Royal Hospital For Children
- Royal Hospital for Sick Children
- Royal Hospital For Children
- St. James's University Hospital; Leeds Regional Paediatric Oncology Unit
- Alder Hey Children s Hospital; Department of Pediatrics
- Great Ormond Street Hospital; Dept. Of Pediatric Oncology
- Royal Manchester Children's Hospital
- The Royal Victoria Infirmary; Paediatric and Adolescent Oncology Unit
- University Hospital Queens Medical Centre; Department of Paediatric Oncology
- Royal Marsden Hospital; Pediatric Unit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Bevacizumab + Chemotherapy
Chemotherapy
Arm Description
Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
Outcomes
Primary Outcome Measures
Percentage of Participants Who Experienced Event-Free Survival (EFS) Events as Per Independent Review Committee (IRC) Assessment
EFS events included tumor progression (IRC assessed), no evidence of response after 3 cycles of induction (derived from IRC assessment), second primary cancer, or death due to any cause. Data for participants who had not experienced an event by the time of clinical cut-off were censored at the date of the last disease assessment prior to the clinical cut-off date. Data for participants who did not have any post-baseline disease assessments were censored at the time of randomization. Tumor progression was defined using Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-target lesions.
EFS Duration as Per IRC Assessment
EFS was defined as the time between randomization and occurrence of EFS event. EFS events are described in Outcome Measure 1. Median EFS was estimated using Kaplan-Meier estimates and 95% confidence intervals (CI) for median was computed using the method of Brookmeyer and Crowley.
Secondary Outcome Measures
Percentage of Participants With Objective Response Prior to First Local Therapy Assessed by RECIST v1.0 Criteria
Objective response prior to first local therapy (surgery and/or radiotherapy) was defined as complete response (CR) or partial response (PR) determined on two consecutive occasions >/=4 weeks apart. Tumor response was assessed as per IRC using RECIST v1.0. CR was defined as disappearance of all target and non-target lesions. If immunocytology was available, no disease was to be detected by that methodology. PR was defined as at least a 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry.
Percentage of Participants Who Experienced EFS Events Among Participants Who Had Objective Response
EFS events was described in Outcome Measure 1 and Outcome Measure 3.
Duration of Response
Duration of Response was defined as time between first objective response and the occurrence of an EFS event (described in Outcome Measure 1). Objective response was defined in Outcome Measure 3. Median duration of response was estimated using Kaplan-Meier estimates and 95% CI for median was computed using the method of Brookmeyer and Crowley.
Percentage of Participants Who Died
Overall Survival Duration
Overall survival was defined as the time between randomization and death due to any cause. Participants without an event were censored at the last time they were known to be alive. Median overall survival was estimated using Kaplan-Meier estimates and 95% CI for median was computed using the method of Brookmeyer and Crowley.
Area Under the Curve at Steady State (AUCss) of Bevacizumab
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUCss is expressed in milligrams times days per milliliter (mg*day/mL).
Volume of Distribution of Bevacizumab
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Half-Life of Bevacizumab
Half-life is the time measured for the plasma concentration to decrease by one half.
Clearance of Bevacizumab
CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL is expressed in milliliters per day (mL/day).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00643565
Brief Title
A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma.
Official Title
An Open-label, Multi-center, Randomized Study of the Safety and Effect on Event-free Survival of Bevacizumab in Combination With Standard Chemotherapy in Childhood and Adolescent Patients With Metastatic Rhabdomyosarcoma and Non-rhabdomyosarcoma Soft Tissue Sarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
July 29, 2008 (Actual)
Primary Completion Date
May 31, 2015 (Actual)
Study Completion Date
April 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
4. Oversight
5. Study Description
Brief Summary
This open-label two-arm study will assess the safety and efficacy of a combination of bevacizumab + standard chemotherapy with standard chemotherapy alone as active comparator in childhood and adolescent patients with metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma. Patients will be randomized to receive bevacizumab + standard chemotherapy or standard chemotherapy alone. Treatment will consist of 9 x 3-week cycles of induction treatment (standard chemotherapy with or without bevacizumab 7.5 mg/kg iv on day 1 of each cycle) followed by 12 x 4-week cycles of maintenance treatment (standard chemotherapy with or without bevacizumab 5 mg/kg iv on days 1 and 15 of each cycle). The anticipated time on study treatment is 1-2 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bevacizumab + Chemotherapy
Arm Type
Experimental
Arm Description
Participants received continuous IV infusion of bevacizumab (7.5 mg/kg every 3 weeks) on Day 1 of 3-week cycles followed by induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy) as per institutional practice for a total of 9 cycles during induction treatment phase. As per the investigator decision, local therapy (radiotherapy and /or surgery) was expected to start after 4 weeks of the last bevacizumab administration in the induction phase and resumed to bevacizumab in the maintenance phase at least 4 weeks after the last dose of local therapy. During maintenance treatment phase, participants received IV infusion of bevacizumab (5 mg/kg every 2 weeks) followed by vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Days 1 and 15 of 4-week cycles for a total of 12 cycles.
Arm Title
Chemotherapy
Arm Type
Active Comparator
Arm Description
Participants received 9 cycles of induction chemotherapy (4 cycles of IVADo-containing chemotherapy followed by 5 cycles of IVA-containing chemotherapy administered every 3 weeks as per institutional practice. As per the investigator evaluation, participants had option to undergo local therapy (radiotherapy and /or surgery) during last 3 cycles of IVA (i.e. from Cycle 6 to Cycle 9). During maintenance treatment phase, participants received vinorelbine- and cyclophosphamide-containing chemotherapy (as per institutional practice) on Day 1 and 15 of 4-week cycles for a total of 12 cycles.
Intervention Type
Drug
Intervention Name(s)
Standard chemotherapy
Intervention Description
As prescribed
Intervention Type
Drug
Intervention Name(s)
bevacizumab [Avastin]
Intervention Description
7.5 mg/kg iv on day 1 of 9 x 3-week cycles, followed by 5 mg/kg iv on days 1 and 15 of each 4-week cycle
Primary Outcome Measure Information:
Title
Percentage of Participants Who Experienced Event-Free Survival (EFS) Events as Per Independent Review Committee (IRC) Assessment
Description
EFS events included tumor progression (IRC assessed), no evidence of response after 3 cycles of induction (derived from IRC assessment), second primary cancer, or death due to any cause. Data for participants who had not experienced an event by the time of clinical cut-off were censored at the date of the last disease assessment prior to the clinical cut-off date. Data for participants who did not have any post-baseline disease assessments were censored at the time of randomization. Tumor progression was defined using Response Evaluation Criteria in Solid Tumors version 1.0 (RECIST v1.0) as at least a 20% increase in the disease measurement, taking as reference the smallest disease measurement recorded since the start of treatment, or the appearance of one or more new lesions, or evidence of clinical progression and unequivocal progression of existing non-target lesions.
Time Frame
Screening up to approximately 6.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years)
Title
EFS Duration as Per IRC Assessment
Description
EFS was defined as the time between randomization and occurrence of EFS event. EFS events are described in Outcome Measure 1. Median EFS was estimated using Kaplan-Meier estimates and 95% confidence intervals (CI) for median was computed using the method of Brookmeyer and Crowley.
Time Frame
Screening up to approximately 6.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years)
Secondary Outcome Measure Information:
Title
Percentage of Participants With Objective Response Prior to First Local Therapy Assessed by RECIST v1.0 Criteria
Description
Objective response prior to first local therapy (surgery and/or radiotherapy) was defined as complete response (CR) or partial response (PR) determined on two consecutive occasions >/=4 weeks apart. Tumor response was assessed as per IRC using RECIST v1.0. CR was defined as disappearance of all target and non-target lesions. If immunocytology was available, no disease was to be detected by that methodology. PR was defined as at least a 30% decrease in the disease measurement, taking as reference the disease measurement done to confirm measurable disease at study entry.
Time Frame
Screening up to approximately 6.75 years
Title
Percentage of Participants Who Experienced EFS Events Among Participants Who Had Objective Response
Description
EFS events was described in Outcome Measure 1 and Outcome Measure 3.
Time Frame
Screening up to approximately 6.75 years
Title
Duration of Response
Description
Duration of Response was defined as time between first objective response and the occurrence of an EFS event (described in Outcome Measure 1). Objective response was defined in Outcome Measure 3. Median duration of response was estimated using Kaplan-Meier estimates and 95% CI for median was computed using the method of Brookmeyer and Crowley.
Time Frame
Screening up to approximately 6.75 years
Title
Percentage of Participants Who Died
Time Frame
Screening up to approximately 10.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years.
Title
Overall Survival Duration
Description
Overall survival was defined as the time between randomization and death due to any cause. Participants without an event were censored at the last time they were known to be alive. Median overall survival was estimated using Kaplan-Meier estimates and 95% CI for median was computed using the method of Brookmeyer and Crowley.
Time Frame
Screening up to approximately 10.75 years (assessed at screening, Cycles 4, 7 of induction phase, Cycles 1, 4, 7, 10 of maintenance, then every 3 months for 1.5 years and thereafter every 6 months for 2.5 years)
Title
Area Under the Curve at Steady State (AUCss) of Bevacizumab
Description
AUC is a measure of the serum concentration of the drug over time. It is used to characterize drug absorption. AUCss is expressed in milligrams times days per milliliter (mg*day/mL).
Time Frame
Pre- and within 3 hours post-dose on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2-4 of induction phase
Title
Volume of Distribution of Bevacizumab
Description
Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Steady state volume of distribution (Vss) is the apparent volume of distribution at steady-state.
Time Frame
Pre- and within 3 hours post-dose on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2-4 of induction phase (1 cycle = 3 weeks)
Title
Half-Life of Bevacizumab
Description
Half-life is the time measured for the plasma concentration to decrease by one half.
Time Frame
Pre- and within 3 hours post-dose on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2-4 of induction phase (1 cycle = 3 weeks)
Title
Clearance of Bevacizumab
Description
CL is a quantitative measure of the rate at which a drug substance is removed from the body. CL is expressed in milliliters per day (mL/day).
Time Frame
Pre- and within 3 hours post-dose on Days 1, 8, and 15 of Cycle 1, Day 1 of Cycle 2-4 of induction phase (1 cycle = 3 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
childhood and adolescent patients aged >/=6 months to 18 years of age
metastatic rhabdomyosarcoma or non-rhabdomyosarcoma soft tissue sarcoma
adequate bone marrow function
adequate renal and liver function
adequate blood clotting
Exclusion Criteria:
previous malignant tumors
tumor invading major blood vessels
prior systemic anti-tumor treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Enfants Reine Fabiola
City
Bruxelles
ZIP/Postal Code
1020
Country
Belgium
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
Instituto Nacional do Cancer - INCA
City
Rio de Janeiro
State/Province
RJ
ZIP/Postal Code
20560-120
Country
Brazil
Facility Name
Clinica de Oncologia de Porto Alegre - CliniOnco
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90430-090
Country
Brazil
Facility Name
Hospital de Cancer de Barretos
City
Barretos
State/Province
SP
ZIP/Postal Code
14784-400
Country
Brazil
Facility Name
Instituto de Oncologia Pediatrica
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023-062
Country
Brazil
Facility Name
ITACI - Instituto de Tratamento do Cancer Infantil
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05410-030
Country
Brazil
Facility Name
Hospital Santa Marcelina
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
08270-070
Country
Brazil
Facility Name
Hospital For Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
Pavillion Chul-Chuq
City
Sainte-foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
Hospital Luis Calvo Mackenna; Oncologia
City
Santiago
ZIP/Postal Code
7500539
Country
Chile
Facility Name
Fakultni nemocnice Brno
City
Brno
ZIP/Postal Code
613 00
Country
Czechia
Facility Name
Fakultni nemocnice v Motole
City
Praha 5
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
CHU Bordeaux; Unite Onco-Hematologie Pediatrique
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Centre Oscar Lambret; Service de Pediatrie
City
Lille
ZIP/Postal Code
59020
Country
France
Facility Name
Centre Leon Berard; Pediatrie
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
Hopital Timone Enfants; Onco Pediatrie
City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
Chr De Nantes; Service D'oncologie Pediatrique
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Institut Curie; Oncologie Medicale
City
Paris
ZIP/Postal Code
75231
Country
France
Facility Name
CHU Hopital Sud; Service d'Hematologie Pediatrique
City
Rennes
ZIP/Postal Code
35203
Country
France
Facility Name
Hopital Des Enfants; Service d Hemato-Oncologie
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHU Hopital d Enfants; Centre hospitalier Universitaire Nancy
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Institut Gustave Roussy; Service Pediatrique
City
Villejuif
ZIP/Postal Code
94805
Country
France
Facility Name
University Hospital Essen; Department of Pediatric Oncology
City
Essen
ZIP/Postal Code
45122
Country
Germany
Facility Name
Universitaetsklinikum Freiburg - PS; Partnersite - Onkologie
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitatsklinikum Munster; Padiatrische Hamatologie und Onkologie
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Soroka Medical Center
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Facility Name
Rambam Health Care Campus; Pediatric Hematology Oncology Department
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Schneider Children's Medical Center
City
Petach-Tikva
ZIP/Postal Code
49100
Country
Israel
Facility Name
Tel Aviv Sourasky MC, Dana Children's Hospital; Pediatric Hemato-Oncology Clinic
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Ospedale Pediatrico Bambino Gesu
City
Roma
State/Province
Lazio
ZIP/Postal Code
00165
Country
Italy
Facility Name
Istituto Gaslini Ospedale Pediatrico; Dipartimento di Oncoematologia pediatrica
City
Genova
State/Province
Liguria
ZIP/Postal Code
16148
Country
Italy
Facility Name
Istituto Nazionale Tumori di Milano; S.C. Oncologia Pediatrica
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Dipartimento di Scienze Pediatriche Adolescenza; Osp. Infantile Regina Margherita
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
U.O.A University Onco-Ematologia Pedicatria; Azienda Ospedaliera A.Meyer
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50132
Country
Italy
Facility Name
Azienda Ospedaliera di Padova; Clinica di Onco-ematologia pediatrica
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Emma Kinderziekenhuis; Dept of Pediatric Oncology
City
Amsterdam
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Erasmus Mc/Sophia's Childrens Hospital; Dept. of Pediatric Oncology
City
Rotterdam
ZIP/Postal Code
3015 GJ
Country
Netherlands
Facility Name
Prinses Maxima Centrum
City
Utrecht
ZIP/Postal Code
3584 CS
Country
Netherlands
Facility Name
Uniwersytet Medyczny W Lublinie; Klinika Hematologii i Onkologii Dzieciecej
City
Lublin
ZIP/Postal Code
20-093
Country
Poland
Facility Name
Instytut Pomnik-Centrum Zdrowia Dziecka; Klinika Onkologii
City
Warsaw
ZIP/Postal Code
04-746
Country
Poland
Facility Name
Center for Children's Hematology, Oncology and Immunology
City
Moscow
ZIP/Postal Code
117198
Country
Russian Federation
Facility Name
Saint-Petersburg SHI City Clinical Hospital #31
City
St. Petersburg
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Hospital de Cruces
City
Barakaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron; Servicio de Nefrologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Infantil Universitario Nino Jesus
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Facility Name
Hospital Regional Universitario Carlos Haya;Servicio Oncologia Pediatrica
City
Malaga
ZIP/Postal Code
29011
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio; Servicio de Onco-Hematologia Pediatrica
City
Sevilla
ZIP/Postal Code
41 41013
Country
Spain
Facility Name
Hospital Universitario La Fe
City
Valencia
ZIP/Postal Code
46014
Country
Spain
Facility Name
Birmingham Childrens Hospital; Oncology Dept
City
Birmingham
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Facility Name
Bristol Royal Hospital For Children
City
Bristol
ZIP/Postal Code
BS2 8BJ
Country
United Kingdom
Facility Name
Royal Hospital for Sick Children
City
Edinburgh
ZIP/Postal Code
EH91LF
Country
United Kingdom
Facility Name
Royal Hospital For Children
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
St. James's University Hospital; Leeds Regional Paediatric Oncology Unit
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Alder Hey Children s Hospital; Department of Pediatrics
City
Liverpool
ZIP/Postal Code
L12 2AP
Country
United Kingdom
Facility Name
Great Ormond Street Hospital; Dept. Of Pediatric Oncology
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Facility Name
Royal Manchester Children's Hospital
City
Manchester
ZIP/Postal Code
M27 4HA
Country
United Kingdom
Facility Name
The Royal Victoria Infirmary; Paediatric and Adolescent Oncology Unit
City
Newcastle Upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
University Hospital Queens Medical Centre; Department of Paediatric Oncology
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Royal Marsden Hospital; Pediatric Unit
City
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
35709412
Citation
Schoot RA, Chisholm JC, Casanova M, Minard-Colin V, Geoerger B, Cameron AL, Coppadoro B, Zanetti I, Orbach D, Kelsey A, Rogers T, Guizani C, Elze M, Ben-Arush M, McHugh K, van Rijn RR, Ferman S, Gallego S, Ferrari A, Jenney M, Bisogno G, Merks JHM. Metastatic Rhabdomyosarcoma: Results of the European Paediatric Soft Tissue Sarcoma Study Group MTS 2008 Study and Pooled Analysis With the Concurrent BERNIE Study. J Clin Oncol. 2022 Nov 10;40(32):3730-3740. doi: 10.1200/JCO.21.02981. Epub 2022 Jun 16.
Results Reference
derived
PubMed Identifier
32179448
Citation
Ferrari A, Merks JHM, Chisholm JC, Orbach D, Brennan B, Gallego S, van Noesel MM, McHugh K, van Rijn RR, Gaze MN, Martelli H, Bergeron C, Corradini N, Minard-Colin V, Bisogno G, Geoerger B, Caron HN, De Salvo GL, Casanova M. Outcomes of metastatic non-rhabdomyosarcoma soft tissue sarcomas (NRSTS) treated within the BERNIE study: a randomised, phase II study evaluating the addition of bevacizumab to chemotherapy. Eur J Cancer. 2020 May;130:72-80. doi: 10.1016/j.ejca.2020.01.029. Epub 2020 Mar 13.
Results Reference
derived
PubMed Identifier
28738258
Citation
Chisholm JC, Merks JHM, Casanova M, Bisogno G, Orbach D, Gentet JC, Thomassin-Defachelles AS, Chastagner P, Lowis S, Ronghe M, McHugh K, van Rijn RR, Hilton M, Bachir J, Furst-Recktenwald S, Geoerger B, Oberlin O; European paediatric Soft tissue sarcoma Study Group (EpSSG) and the European Innovative Therapies for Children with Cancer (ITCC) Consortium. Open-label, multicentre, randomised, phase II study of the EpSSG and the ITCC evaluating the addition of bevacizumab to chemotherapy in childhood and adolescent patients with metastatic soft tissue sarcoma (the BERNIE study). Eur J Cancer. 2017 Sep;83:177-184. doi: 10.1016/j.ejca.2017.06.015. Epub 2017 Aug 23.
Results Reference
derived
Learn more about this trial
A Study of Avastin (Bevacizumab) in Combination With Standard Chemotherapy in Children and Adolescents With Sarcoma.
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