Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT01390948
Registration number
NCT01390948
Ethics application status
Date submitted
7/07/2011
Date registered
11/07/2011
Date last updated
6/08/2020
Titles & IDs
Public title
A Study of Bevacizumab (Avastin) in Combination With Temozolomide (TMZ) and Radiotherapy in Paediatric and Adolescent Participants With High-Grade Glioma
Query!
Scientific title
A Phase II Open-Label, Randomized, Multi-Centre Comparative Study Of Bevacizumab-Based Therapy In Paediatric Patients With Newly Diagnosed Supratentorial, Infratentorial Cerebellar, or Peduncular High-Grade Glioma
Query!
Secondary ID [1]
0
0
2010-022189-28
Query!
Secondary ID [2]
0
0
BO25041
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
High Grade Glioma
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Brain
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Bevacizumab
Treatment: Other - Radiotherapy
Treatment: Drugs - Temozolomide (TMZ)
Experimental: Bevacizumab + TMZ Young Patient Cohort (YPC) - Participants aged greater than or equal to (\>/=) 6 months and less than (\<) 3 years will receive 10 milligrams per kilogram (mg/kg) Bevacizumab every 2 weeks and 150 to 200 milligrams per meter squared (mg/m\^2) of TMZ daily on Days 1-5 of each cycle. TMZ will be given at a dose of 150 mg/m\^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m\^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
Experimental: Main Cohort: Chemoradiation + Bevacizumab + TMZ - Participants will receive a total dose of 54 Grey (Gy) units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m\^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break will be followed by an adjuvant treatment phase where participants will receive 150 to 200 mg/m\^2 of TMZ daily on Days 1-5 of each cycle. TMZ will be given at a dose of 150 mg/m\^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m\^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle. Bevacizumab will be given concomitantly at a dose of 10 mg/kg every 2 weeks throughout the entire treatment period.
Active comparator: Main Cohort: Chemoradiation + TMZ - Participants will receive a total dose of 54 Gy units delivered in 30 daily fractions of 1.8 Gy over 6 weeks with 75 mg/m\^2 TMZ daily for up to 49 days followed by a treatment break of approximately 4 weeks. The treatment break will be followed by an adjuvant treatment phase where participants will receive 150 to 200 mg/m\^2 of TMZ daily on Days 1-5 of each cycle. TMZ will be given at a dose of 150 mg/m\^2 on Days 1-5 of cycle 1 and then escalated to 200 mg/m\^2 on days 1-5 from cycle 2 onwards depending on the tolerance during the 1st cycle.
Treatment: Drugs: Bevacizumab
10 milligrams per kilogram every 2 weeks during the study for up to 12 cycles, each cycle length of 28 days
Treatment: Other: Radiotherapy
Total dose of 54 Grey (Gy) units delivered in 30 daily fractions of 1.8 Gy over 6 weeks during the chemoradiation phase.
Treatment: Drugs: Temozolomide (TMZ)
75 milligrams per square meter (mg/m\^2) daily continuous starting concomitantly with the first radiation fraction and ending with the last radiation fraction for a maximum number of treatment days = 49 days. During the TMZ adjuvant treatment phase and for participants from YPC: TMZ (150 to 200 mg/m\^2/day) x 12 cycles, 1st cycle 150 mg/m\^2/days 1-5, escalated to 200 mg/m\^2 on Days 1-5 from Cycle 2 onwards depending on the tolerance during the 1st cycle. Cycle length = 28 days.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Intervention code [2]
0
0
Treatment: Other
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Event-Free Survival (EFS) as Assessed by the Central Radiology Review Committee (CRRC)
Query!
Assessment method [1]
0
0
EFS was defined as the time from randomisation to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non- HGG malignancy or death attributable to any cause. Tumor assessments were conducted using magnetic resonance imaging (MRI) and reviewed by the site-independent CRRC using Response Assessment in Neuro-Oncology (RANO) criteria. Tumor progression was defined as clear clinical progression or \>/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the subject on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method.
Query!
Timepoint [1]
0
0
From the time of randomization to the date of any defined event (up to 12 months)
Query!
Secondary outcome [1]
0
0
Overall Survival
Query!
Assessment method [1]
0
0
Overall Survival was defined as the time of diagnosis to the date of death due to any cause. Overall Survival was estimated using the Kaplan-Meier method.
Query!
Timepoint [1]
0
0
From the time of randomization to the date of death (up to approximately 60 months)
Query!
Secondary outcome [2]
0
0
Percentage of Participants With 1-Year Survival
Query!
Assessment method [2]
0
0
1-year survival was estimated using the Kaplan-Meier method.
Query!
Timepoint [2]
0
0
1 year after end of treatment
Query!
Secondary outcome [3]
0
0
Percentage of Participants With EFS as Determined by the CRRC at 6 Months
Query!
Assessment method [3]
0
0
EFS was defined as the time from randomisation to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non- HGG malignancy or death attributable to any cause. Tumor assessments were conducted using MRI and reviewed by the site-independent CRRC using RANO criteria. Tumor progression was defined as clear clinical progression or \>/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the subject on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method.
Query!
Timepoint [3]
0
0
6 months
Query!
Secondary outcome [4]
0
0
Percentage of Participants With EFS as Determined by the CRRC at 1 Year
Query!
Assessment method [4]
0
0
EFS was defined as the time from randomisation to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non- HGG malignancy or death attributable to any cause. Tumor assessments were conducted using MRI and reviewed by the site-independent CRRC using RANO criteria. Tumor progression was defined as clear clinical progression or \>/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the subject on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method.
Query!
Timepoint [4]
0
0
1 year
Query!
Secondary outcome [5]
0
0
EFS as Assessed by the Investigator
Query!
Assessment method [5]
0
0
EFS was defined as the time from randomisation to the earliest occurrence of any of the following: tumor progression, tumor recurrence, second primary non-HGG malignancy or death attributable to any cause. Tumor assessments were conducted using MRI and reviewed by the investigator using RANO criteria. Tumor progression was defined as clear clinical progression or \>/= 25% increase in the sum of the products of perpendicular diameters of the contrast enhancing lesions compared with the smallest tumor measurement obtained either at baseline (if no decrease was observed) or best response and with the participant on stable or increasing doses of corticosteroids. Tumor recurrence was defined as recurrence after tumor was completely resected (no disease present at baseline). EFS was estimated using the Kaplan-Meier method.
Query!
Timepoint [5]
0
0
From the time of randomization to the date of any defined event (up to 12 months)
Query!
Secondary outcome [6]
0
0
Objective Response Rate (ORR)
Query!
Assessment method [6]
0
0
ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) determined on two consecutive occasions \>/= 4 weeks apart. Tumor assessments were conducted using MRI and reviewed by the site-independent CRRC using RANO criteria. The following were needed to qualify as CR: complete disappearance of all measurable enhancing lesions sustained for at least 4 weeks by MRI, no steroids above physiological levels, clinical status stable or improved compared to baseline. The following were needed to qualify as PR: = 50% decrease from baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions sustained for at least 4 weeks by MRI, steroid dose not increased compared to baseline, clinical status stable or improved compared to baseline.
Query!
Timepoint [6]
0
0
From the time of randomization to the date of any defined event (up to 12 months)
Query!
Secondary outcome [7]
0
0
Concordance Between Structural Versus Multimodal Imaging for CRRC-Assessed Event-Free Survival
Query!
Assessment method [7]
0
0
Concordance is presented as the percentage of participants with concordance between assessments. EFS concordance was defined as event Structural assessment and Diffusion Perfusion assessment occurs within 28 days or no event Structural and no Diffusion Perfusion.
Query!
Timepoint [7]
0
0
Up to 12 months
Query!
Secondary outcome [8]
0
0
Health Status as Measured by the Health Utility Index (HUI)
Query!
Assessment method [8]
0
0
HUI is a preference-based, multi-attitude, health-related instrument specifically developed for use with children. HUI consists of eight attributes of health status: vision, hearing, speech, ambulation, dexterity, emotion, cognition and pain. Each attribute had 5 or 6 levels varying from highly impaired to normal. Each of the eight health dimensions was tested separately and a composite score ranging between 1 (perfect health) and 0 (death) was obtained for participants aged 5 years or older.
Query!
Timepoint [8]
0
0
Baseline, Cycle 6 of the adjuvant phase, end of treatment (approximately 58 weeks post-baseline), and yearly during the follow-up period (maximum 5 years in follow-up)
Query!
Secondary outcome [9]
0
0
Neurological Psychological Function as Measured by the Wechsler Scale
Query!
Assessment method [9]
0
0
The Wechsler Intelligence Scale for Children version IV (WISC-IV) was used to generate a full scale intelligence quotient (IQ) which represents a child's general intellectual ability. The average IQ score is 100, with lower scores representing lower intellectual ability.
Query!
Timepoint [9]
0
0
End of treatment (approximately 58 weeks post-baseline)
Query!
Secondary outcome [10]
0
0
Percentage of Participants Who Completed >/= 90% of Planned Radiotherapy and TMZ Administrations
Query!
Assessment method [10]
0
0
Query!
Timepoint [10]
0
0
From the time of randomization of the first participant to the date of clinical cutoff (approximately 60 months)
Query!
Secondary outcome [11]
0
0
Percentage of Participants With a Treatment Delay or Discontinuation
Query!
Assessment method [11]
0
0
Query!
Timepoint [11]
0
0
From the time of randomization of the first participant to the date of clinical cutoff (approximately 60 months)
Query!
Secondary outcome [12]
0
0
Number of Radiotherapy Dose Administrations in the Concurrent Phase
Query!
Assessment method [12]
0
0
Number of doses were assessed for the concurrent phase, which is the treatment period after the initial treatment phase and including the subsequent treatment break of approximately 4 weeks.
Query!
Timepoint [12]
0
0
Beginning of the concurrent phase to end of treatment break (10 weeks)
Query!
Secondary outcome [13]
0
0
Number of Dose Administrations of TMZ and Bevacizumab in the Concurrent Phase
Query!
Assessment method [13]
0
0
Number of doses were assessed for the concurrent phase, which is the treatment period after the initial treatment phase and including the subsequent treatment break of approximately 4 weeks.
Query!
Timepoint [13]
0
0
Beginning of the concurrent phase to end of treatment break (10 weeks)
Query!
Secondary outcome [14]
0
0
Percentage of Participants With an Adverse Event (AE)
Query!
Assessment method [14]
0
0
An AE was defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Query!
Timepoint [14]
0
0
From the time of randomization of the first participant to the date of clinical cutoff (approximately 60 months)
Query!
Eligibility
Key inclusion criteria
Inclusion Criteria - Main cohort :
* Paediatric participants, aged >= 3 years and < 18 years
* Written informed consent obtained from the participant/parents or legally acceptable representative
* Newly diagnosed localised, supratentorial or infratentorial cerebellar or peduncular, WHO Grade III or IV gliomas
* Local histological diagnosis confirmed by a designated central reference neuropathologist
* Availability of the baseline magnetic resonance imaging (MRI) performed according to imaging guidelines
* Able to commence trial treatment not before 4 weeks after cranial surgery and no later than 6 weeks following the last major surgery
* Adequate bone marrow, coagulation, liver, and renal function
Young Participant Cohort
* Written informed consent obtained from parents or legal representative
* Age at enrollment: from >= 6 months to < 3 years of age
* Progressive or relapsed metastatic or localised, supra- or infratentorial, non-brain stem WHO Grade III or IV glioma (local pathology confirmation made either at initial diagnosis or at relapse)
* Availability of a baseline MRI performed according to imaging guidelines
* Adequate organ function (bone marrow, coagulation, liver, kidney)
Query!
Minimum age
6
Months
Query!
Query!
Maximum age
18
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Exclusion Criteria - Main cohort:
* Metastatic HGG defined as evidence of neuraxis dissemination by MRI or positive cerebrospinal fluid (CSF) cytology
* WHO-defined Gliomatosis cerebri (multifocal HGG)
* Any disease or condition that contraindicates the use of the study medication/treatment or places the patient at an unacceptable risk of experiencing treatment-related complications
* Radiological evidence of surgically related intracranial bleeding
* Prior diagnosis of a malignancy and disease-free for 5 years
* Prior systemic anti-cancer therapy
* Previous cranial irradiation
Young Participant Cohort
* WHO-defined Gliomatosis cerebri (multifocal HGG)
* Newly diagnosed HGG below the age of 3 years
* Relapsed HGG below the age of 6 months or above the age of 3 years regardless of the age at first onset
* Indication for concomitant cranial irradiation, regardless of age
* Any disease or condition that contraindicates the use of the study medication/treatment or places the child at an unacceptable risk of experiencing treatment-related complications
* Any specific contraindication to MRI
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
18/10/2011
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
29/01/2020
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
124
Query!
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Query!
Recruitment hospital [1]
0
0
The Children's Hospital at Westmead - Westmead
Query!
Recruitment hospital [2]
0
0
Lady Cilento Children's Hospital; Oncology Services Group, Level 12b - South Brisbane
Query!
Recruitment postcode(s) [1]
0
0
2145 - Westmead
Query!
Recruitment postcode(s) [2]
0
0
QLD 4101 - South Brisbane
Query!
Recruitment outside Australia
Country [1]
0
0
Austria
Query!
State/province [1]
0
0
Linz
Query!
Country [2]
0
0
Austria
Query!
State/province [2]
0
0
Wien
Query!
Country [3]
0
0
Belgium
Query!
State/province [3]
0
0
Leuven
Query!
Country [4]
0
0
Canada
Query!
State/province [4]
0
0
Alberta
Query!
Country [5]
0
0
Canada
Query!
State/province [5]
0
0
Ontario
Query!
Country [6]
0
0
Czechia
Query!
State/province [6]
0
0
Brno
Query!
Country [7]
0
0
Czechia
Query!
State/province [7]
0
0
Prague
Query!
Country [8]
0
0
Denmark
Query!
State/province [8]
0
0
Aarhus N
Query!
Country [9]
0
0
Denmark
Query!
State/province [9]
0
0
København Ø
Query!
Country [10]
0
0
France
Query!
State/province [10]
0
0
Angers
Query!
Country [11]
0
0
France
Query!
State/province [11]
0
0
Clermont Ferrand
Query!
Country [12]
0
0
France
Query!
State/province [12]
0
0
Lille
Query!
Country [13]
0
0
France
Query!
State/province [13]
0
0
Lyon
Query!
Country [14]
0
0
France
Query!
State/province [14]
0
0
Marseille
Query!
Country [15]
0
0
France
Query!
State/province [15]
0
0
Nice
Query!
Country [16]
0
0
France
Query!
State/province [16]
0
0
Paris
Query!
Country [17]
0
0
France
Query!
State/province [17]
0
0
Rennes
Query!
Country [18]
0
0
France
Query!
State/province [18]
0
0
St Priest En Jarez
Query!
Country [19]
0
0
France
Query!
State/province [19]
0
0
Strasbourg
Query!
Country [20]
0
0
France
Query!
State/province [20]
0
0
Toulouse
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Tours
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Vandoeuvre-les-Nancy cedex
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
Villejuif
Query!
Country [24]
0
0
Hungary
Query!
State/province [24]
0
0
Budapest
Query!
Country [25]
0
0
Italy
Query!
State/province [25]
0
0
Emilia-Romagna
Query!
Country [26]
0
0
Italy
Query!
State/province [26]
0
0
Liguria
Query!
Country [27]
0
0
Italy
Query!
State/province [27]
0
0
Lombardia
Query!
Country [28]
0
0
Italy
Query!
State/province [28]
0
0
Veneto
Query!
Country [29]
0
0
Netherlands
Query!
State/province [29]
0
0
Nijmegen
Query!
Country [30]
0
0
Netherlands
Query!
State/province [30]
0
0
Rotterdam
Query!
Country [31]
0
0
Poland
Query!
State/province [31]
0
0
Warsaw
Query!
Country [32]
0
0
Spain
Query!
State/province [32]
0
0
Barcelona
Query!
Country [33]
0
0
Spain
Query!
State/province [33]
0
0
Valencia
Query!
Country [34]
0
0
Sweden
Query!
State/province [34]
0
0
Göteborg
Query!
Country [35]
0
0
Sweden
Query!
State/province [35]
0
0
Linkoeping
Query!
Country [36]
0
0
Sweden
Query!
State/province [36]
0
0
Lund
Query!
Country [37]
0
0
Sweden
Query!
State/province [37]
0
0
Solna
Query!
Country [38]
0
0
United Kingdom
Query!
State/province [38]
0
0
Birmingham
Query!
Country [39]
0
0
United Kingdom
Query!
State/province [39]
0
0
Bristol
Query!
Country [40]
0
0
United Kingdom
Query!
State/province [40]
0
0
Cambridge
Query!
Country [41]
0
0
United Kingdom
Query!
State/province [41]
0
0
Edinburgh
Query!
Country [42]
0
0
United Kingdom
Query!
State/province [42]
0
0
Leeds
Query!
Country [43]
0
0
United Kingdom
Query!
State/province [43]
0
0
Liverpool
Query!
Country [44]
0
0
United Kingdom
Query!
State/province [44]
0
0
London
Query!
Country [45]
0
0
United Kingdom
Query!
State/province [45]
0
0
Manchester
Query!
Country [46]
0
0
United Kingdom
Query!
State/province [46]
0
0
Newcastle upon Tyne
Query!
Country [47]
0
0
United Kingdom
Query!
State/province [47]
0
0
Nottingham
Query!
Country [48]
0
0
United Kingdom
Query!
State/province [48]
0
0
Southampton
Query!
Country [49]
0
0
United Kingdom
Query!
State/province [49]
0
0
Surrey
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Hoffmann-La Roche
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
This randomized, open-label, multicenter, 2-arm study will investigate the efficacy, safety, tolerability and pharmacokinetics of bevacizumab when added to postoperative radiotherapy with concomitant and adjuvant TMZ as compared to postoperative radiotherapy with concomitant and adjuvant TMZ alone in paediatric participants with newly diagnosed histologically confirmed World Health Organization (WHO) Grade III or IV localized supratentorial or infratentorial cerebellar or peduncular high grade glioma (HGG). Participants will be randomly assigned to one of two treatment arms. Upon approval by the Health Authorities/Ethics Committees in the participating countries, an additional young participant cohort (YPC) (children \>/= 6 months and \< 3 years of age with progressive or relapsed metastatic or localized, supra- or infratentorial, non-brain stem WHO Grade III or IV HGG) was included in the study. Children in the YPC will receive bevacizumab and TMZ without radiation therapy. The anticipated time on study treatment is over 1 year.
Query!
Trial website
https://clinicaltrials.gov/study/NCT01390948
Query!
Trial related presentations / publications
Rodriguez D, Calmon R, Aliaga ES, Warren D, Warmuth-Metz M, Jones C, Mackay A, Varlet P, Le Deley MC, Hargrave D, Canete A, Massimino M, Azizi AA, Saran F, Zahlmann G, Garcia J, Vassal G, Grill J, Peet A, Dineen RA, Morgan PS, Jaspan T. MRI and Molecular Characterization of Pediatric High-Grade Midline Thalamic Gliomas: The HERBY Phase II Trial. Radiology. 2022 Jul;304(1):174-182. doi: 10.1148/radiol.211464. Epub 2022 Apr 12. Varlet P, Le Teuff G, Le Deley MC, Giangaspero F, Haberler C, Jacques TS, Figarella-Branger D, Pietsch T, Andreiuolo F, Deroulers C, Jaspan T, Jones C, Grill J. WHO grade has no prognostic value in the pediatric high-grade glioma included in the HERBY trial. Neuro Oncol. 2020 Jan 11;22(1):116-127. doi: 10.1093/neuonc/noz142. Rodriguez D, Chambers T, Warmuth-Metz M, Aliaga ES, Warren D, Calmon R, Hargrave D, Garcia J, Vassal G, Grill J, Zahlmann G, Morgan PS, Jaspan T. Evaluation of the Implementation of the Response Assessment in Neuro-Oncology Criteria in the HERBY Trial of Pediatric Patients with Newly Diagnosed High-Grade Gliomas. AJNR Am J Neuroradiol. 2019 Mar;40(3):568-575. doi: 10.3174/ajnr.A5982. Epub 2019 Feb 28. Mackay A, Burford A, Molinari V, Jones DTW, Izquierdo E, Brouwer-Visser J, Giangaspero F, Haberler C, Pietsch T, Jacques TS, Figarella-Branger D, Rodriguez D, Morgan PS, Raman P, Waanders AJ, Resnick AC, Massimino M, Garre ML, Smith H, Capper D, Pfister SM, Wurdinger T, Tam R, Garcia J, Thakur MD, Vassal G, Grill J, Jaspan T, Varlet P, Jones C. Molecular, Pathological, Radiological, and Immune Profiling of Non-brainstem Pediatric High-Grade Glioma from the HERBY Phase II Randomized Trial. Cancer Cell. 2018 May 14;33(5):829-842.e5. doi: 10.1016/j.ccell.2018.04.004. Grill J, Massimino M, Bouffet E, Azizi AA, McCowage G, Canete A, Saran F, Le Deley MC, Varlet P, Morgan PS, Jaspan T, Jones C, Giangaspero F, Smith H, Garcia J, Elze MC, Rousseau RF, Abrey L, Hargrave D, Vassal G. Phase II, Open-Label, Randomized, Multicenter Trial (HERBY) of Bevacizumab in Pediatric Patients With Newly Diagnosed High-Grade Glioma. J Clin Oncol. 2018 Apr 1;36(10):951-958. doi: 10.1200/JCO.2017.76.0611. Epub 2018 Feb 7.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Trials
Query!
Address
0
0
Hoffmann-La Roche
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01390948
Download to PDF