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High Grade GliomaPhase 2NCT01390948

A Study of Bevacizumab (Avastin) in Combination With Temozolomide (TMZ) and Radiotherapy in Paediatric and Adolescent Participants With High-Grade Glioma

A Phase 2 study testing Bevacizumab, Radiotherapy and Temozolomide (TMZ) in people with High Grade Glioma, run by Hoffmann-La Roche at 53 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 6 months to 18 years
Conditions the study is for
High Grade Glioma
What is being tested?
Bevacizumab, Radiotherapy and Temozolomide (TMZ)
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
53 sitesin 14 countries
Study dates
18 Oct 2011to 29 Jan 2020
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 6 months to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
Show all 13Show fewer
  • 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)

Who cannot join

  • 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
Show all 14Show fewer
  • 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

Trial locations and contacts

53 sites in 14 countries.

53 sites in 14 countries

France14 sites

  • Centre Hospitalier d'Angers; Service de cancérologie pédiatrique

    Angers, 49033

  • CHU ESTAING; Centre Regional de Cancérologie et Thérapie Cellulaire Pédiatrique (CRCTCP)

    Clermont-Ferrand, 63003

  • Centre Oscar Lambret; Service de Pediatrie

    Lille, 59020

  • Centre Leon Berard

    Lyon, 69008

  • Hopital Timone Enfants; Onco Pediatrie

    Marseille, 13385

  • Hopital Lenval; Service Hématologie Infantile

    Nice, 06200

  • Institut Curie - Centre de Lutte Contre le Cancer (CLCC) de Paris; Service d Oncologie Pediatrique

    Paris, 75248

  • CHRU de Rennes - Hôpital Sud- Service d'Hématologie Pédiatrique

    Rennes, 35056

  • Hopital Nord;Consult Pediatrie

    Saint-Priest-en-Jarez, 42777

  • Hôpital Hautepierre

    Strasbourg, 67200

  • Hopital Des Enfants; Service d Hemato-Oncologie

    Toulouse, 31059

  • CHRU de Tours - Centre de Pédiatrie Clocheville; Service d'Oncopédiatrie

    Tours, 37044

  • Hopital Brabois Enfants

    Vandœuvre-lès-Nancy, 54511

  • Institut Gustave Roussy; Service Pediatrique

    Villejuif, 94805

Other trials in France

United Kingdom13 sites

  • Birmingham Childrens Hospital; Oncology Dept

    Birmingham, B4 6NH

  • Bristol Royal Hospital for Children; Paediatric Haematology, Oncology, BMT

    Bristol, BS2 8BJ

  • Addenbrookes Hospital; Paediatric Oncology Ward C2

    Cambridge, CB2 0QQ

  • Royal Hospital for Sick Children

    Edinburgh, EH91LF

  • Leeds General Infirmary; Ward 35

    Leeds, LS1 3EX

  • Alder Hey Children's NHS Foundation Trust

    Liverpool, L12 2AP

  • University College London NHS Foundation Trust

    London, NW1 2PG

  • Great Ormond Street Hospital; Dept. Of Pediatric Oncology

    London, WC1N 3JH

  • Royal Manchester Childrens Hospital

    Manchester, M13 9WL

  • Newcastle University & The Newcastle upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne, NE1 4LP

  • Queens Medical Centre

    Nottingham, NG7 2UH

  • Southampton General Hospital

    Southampton, SO16 6YD

  • Royal Marsden Hospital; Pediatric Unit

    Surrey, SM2 5PT

Other trials in United Kingdom

Italy4 sites

  • Azienda Ospedaliera Universitaria Policlinico Sant'Orsola Malpigh

    Bologna, Emilia-Romagna, 40138

  • Istituto Giannina Gaslini-Ospedale Pediatrico IRCCS; U.O.S. Neuroncologia

    Genoa, Liguria, 16147

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, Lombardy, 20133

  • Azienda Ospedaliera di Padova

    Padova, Veneto, 35128

Other trials in Italy

Sweden4 sites

  • Sahlgrenska Universitetssjukhuset, Östra Sjukhus; Drottning Silvias Barnsjukhus

    Gothenburg, 416 85

  • Universitetssjukhuset Linköping; Barn och Ungdomskliniken

    Linköping, 581 85

  • Skånes Universitetssjukhus

    Lund, 221 85

  • Karolinska Universitetssjukhuset, Solna; Astrid Lindgrens Barnsjukhus, Barcanceravdelningen

    Solna, 171 76

Other trials in Sweden

Spain3 sites

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035

  • Hospital Sant Joan De Deu

    Esplugues de Llobregas, Barcelona, 08950

  • Hospital Universitario La Fe

    Valencia, 46014

Other trials in Spain

Australia2 sites

  • Lady Cilento Children's Hospital; Oncology Services Group, Level 12b

    South Brisbane, Queensland, QLD 4101

  • The Children's Hospital at Westmead

    Westmead, New South Wales, 2145

Other trials in Australia

Austria2 sites

  • Kepler Universitätskliniken GmbH - Med Campus IV.

    Linz, 4020

  • Medizinische Universität Wien

    Vienna, 1090

Other trials in Austria

Canada2 sites

  • Alberta Children'S Hospital

    Calgary, Alberta, T3B 6A8

  • Hospital For Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

Czechia2 sites

  • Fakultni nemocnice Brno; 2. detska klinika, pracoviste Detska nemocnice

    Brno, 62500

  • Fakultni Nemocnice V Motole, S.P.

    Prague, 15060

Other trials in Czechia

Denmark2 sites

  • Skejby Sygehus - Aarhus University Hospital; CF Center, Børneafdeling A

    Aarhus N, 8200

  • Rigshospitalet; Onkologisk Klinik

    København Ø, 2100

Other trials in Denmark

Netherlands2 sites

  • UMC St Radboud

    Nijmegen, 6525 GA

  • Erasmus Mc/Sophia's Childrens Hospital; Dept. of Pediatric Oncology

    Rotterdam, 3015 GJ

Other trials in Netherlands

Belgium1 site

  • UZ Leuven Gasthuisberg

    Leuven, 3000

Other trials in Belgium

Hungary1 site

  • Semmelweis University, 2nd Dept of Pediatrics Neurooncology Unit

    Budapest, 1094

Other trials in Hungary

Poland1 site

  • Instytut Pomnik-Centrum Zdrowia Dziecka; Klinika Onkologii

    Warsaw, 04-746

Other trials in Poland

About this study

Official 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

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.

Being tested
Bevacizumab, Radiotherapy, Temozolomide (TMZ)
Medical subject headings
Glioma

What participants receive

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

  • BevacizumabDrug

    Also called Avastin

    10 milligrams per kilogram every 2 weeks during the study for up to 12 cycles, each cycle length of 28 days

  • RadiotherapyRadiation

    Total dose of 54 Grey (Gy) units delivered in 30 daily fractions of 1.8 Gy over 6 weeks during the chemoradiation phase.

  • Temozolomide (TMZ)Drug

    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.

Study groups in NCT01390948
Study groupRoleWhat they receive
Bevacizumab + TMZ Young Patient Cohort (YPC)ExperimentalParticipants 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.
Receives: Drug: Bevacizumab; Drug: Temozolomide (TMZ)
Main Cohort: Chemoradiation + Bevacizumab + TMZExperimentalParticipants 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.
Receives: Drug: Bevacizumab; Radiation: Radiotherapy; Drug: Temozolomide (TMZ)
Main Cohort: Chemoradiation + TMZActive comparatorParticipants 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.
Receives: Radiation: Radiotherapy; Drug: Temozolomide (TMZ)

What is being measured

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

  1. Event-Free Survival (EFS) as Assessed by the Central Radiology Review Committee (CRRC)

    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.

    Measured: From the time of randomization to the date of any defined event (up to 12 months)

Secondary outcomes (14)

  1. Overall Survival

    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.

    Measured: From the time of randomization to the date of death (up to approximately 60 months)

  2. Percentage of Participants With 1-Year Survival

    1-year survival was estimated using the Kaplan-Meier method.

    Measured: 1 year after end of treatment

  3. Percentage of Participants With EFS as Determined by the CRRC at 6 Months

    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.

    Measured: 6 months

  4. Percentage of Participants With EFS as Determined by the CRRC at 1 Year

    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.

    Measured: 1 year

  5. EFS as Assessed by the Investigator

    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.

    Measured: From the time of randomization to the date of any defined event (up to 12 months)

  6. Objective Response Rate (ORR)

    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.

    Measured: From the time of randomization to the date of any defined event (up to 12 months)

  7. Concordance Between Structural Versus Multimodal Imaging for CRRC-Assessed Event-Free Survival

    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.

    Measured: Up to 12 months

  8. Health Status as Measured by the Health Utility Index (HUI)

    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.

    Measured: 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)

  9. Neurological Psychological Function as Measured by the Wechsler Scale

    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.

    Measured: End of treatment (approximately 58 weeks post-baseline)

  10. Percentage of Participants Who Completed >/= 90% of Planned Radiotherapy and TMZ Administrations

    Measured: From the time of randomization of the first participant to the date of clinical cutoff (approximately 60 months)

  11. Percentage of Participants With a Treatment Delay or Discontinuation

    Measured: From the time of randomization of the first participant to the date of clinical cutoff (approximately 60 months)

  12. Number of Radiotherapy Dose Administrations in the Concurrent Phase

    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.

    Measured: Beginning of the concurrent phase to end of treatment break (10 weeks)

  13. Number of Dose Administrations of TMZ and Bevacizumab in the Concurrent Phase

    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.

    Measured: Beginning of the concurrent phase to end of treatment break (10 weeks)

  14. Percentage of Participants With an Adverse Event (AE)

    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.

    Measured: From the time of randomization of the first participant to the date of clinical cutoff (approximately 60 months)

Timeline

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

  1. First posted11 Jul 2011 (estimated)
  2. Study start18 Oct 2011
  3. Primary completion5 Feb 2016
  4. Study completion29 Jan 2020

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01390948
Sponsor's protocol ID
BO25041
Other IDs
2010-022189-28, ITCC-019, HGG-01
Status last verified
Jul 2020
First submitted
7 Jul 2011
Last updated
6 Aug 2020
Data monitoring committee
Yes

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.

    PubMed 35412366

  • 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.

    PubMed 31419298

  • 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.

    PubMed 30819765

  • 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.

    PubMed 29763623

  • 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.

    PubMed 29412784

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bevacizumab, Radiotherapy and Temozolomide (TMZ) in people with High Grade Glioma, run by Hoffmann-La Roche at 53 sites in 14 countries.

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

Who may be eligible to take part?

The sponsor lists 13 inclusion and 14 exclusion criteria. 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: finished, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in France, United Kingdom, Italy, Sweden, Spain and 9 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Event-Free Survival (EFS) as Assessed by the Central Radiology Review Committee (CRRC) (time frame: From the time of randomization to the date of any defined event (up to 12 months)). 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 NCT01390948, 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 6 Aug 2020.

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