Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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25 November 2019 |
Main ID: |
EUCTR2009-017422-39-NL |
Date of registration:
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16/09/2010 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Randomized trial assessing the significance of Bevacizumab in recurrent grade II and
Grade III gliomas. The TAVAREC trial.
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Scientific title:
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Randomized trial assessing the significance of Bevacizumab in recurrent grade II and
Grade III gliomas. The TAVAREC trial.
- TAVAREC |
Date of first enrolment:
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23/12/2010 |
Target sample size:
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155 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-017422-39 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
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Countries of recruitment
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Austria
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Belgium
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Germany
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Italy
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Netherlands
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Switzerland
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United Kingdom
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Contacts
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Name:
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Medical Department
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Address:
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Av Mounier 83/11
1200
Brussels
Belgium |
Telephone:
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00322774 1047/ |
Email:
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regulatory@eortc.be |
Affiliation:
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European Organisation for Research and Treatment of Cancer |
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Name:
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Medical Department
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Address:
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Av Mounier 83/11
1200
Brussels
Belgium |
Telephone:
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00322774 1047/ |
Email:
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regulatory@eortc.be |
Affiliation:
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European Organisation for Research and Treatment of Cancer |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Histologically proven grade II or grade III astrocytoma, oligodendroglioma or oligoastrocytoma.
- Demonstrated absence of 1p/19q co-deletion.
- Availability of tumor material for central review processes and translational research projects
- First recurrence after initial treatment with either radiotherapy and/or
chemotherapy.
- Enhancing recurrence on MRI scan.
- Absence of any cardiovascular disorder.
- Absence of any thrombotic or hemorrhagic issue.
- Absence of known hypersensitivity.
- No underlying or previous conditions that could interfere with treatment.
- Normal hematological functions.
- Normal liver function.
- Normal renal function.
- Age = 18 years.
- WHO Performance status 0 - 2.
- Women of childbearing potential (WOCBP) must be using an adequate method of contraception
- Before patient randomization, written informed consent must be given according to ICH/GCP, and national/local regulations. Informed consent should also be given for biological material to be stored and used for future research on brain tumors.
Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 72 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 72
Exclusion criteria: - More than one line of chemotherapy.
- Radiotherapy within the three months prior to the diagnosis of progression.
- Radiotherapy with a dose over 65 Gy, stereotactic radiosurgery or brachytherapy unless the recurrence is histologically proven.
- Prior treatment with Bevacizumab or other VEGF inhibitors or VEGF-Receptor signaling inhibitors
- Invasive procedures within 4 weeks prior to randomization.
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cancer [C04]
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Recurrent grade II and grade III gliomas
MedDRA version: 19.0
Level: LLT
Classification code 10027744
Term: Mixed astrocytoma-oligodendroglioma
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 19.0
Level: PT
Classification code 10060971
Term: Astrocytoma malignant
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA version: 19.0
Level: PT
Classification code 10026659
Term: Malignant oligodendroglioma
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Intervention(s)
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Trade Name: Avastin Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: BEVACIZUMAB CAS Number: 216974-75-3 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 25-
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Primary Outcome(s)
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Secondary Objective: Secondary objectives: Safety, patient-oriented assessment of clinical benefit. Exploratory objectives: qualification or discovery of prognostic and/or predictive biomarkers of activity or efficacy. Discordances between RANO and Macdonald's criteria.
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Primary end point(s): The primary endpoint will be probability of survival at 1 year (i.e. patients alive at 12 months, OS12).
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Main Objective: The main objective is to compare the activity of both the combination Temozolomide (TMZ) plus bevacizumab and TMZ alone in recurrent grade II or grade III glioma patients without 1p/19q co-deletion.
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Timepoint(s) of evaluation of this end point: After 12 months
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Secondary Outcome(s)
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Secondary end point(s): Secondary endpoints will be:
- response (distribution, objective response rate, duration of response,
according to RANO criteria)
- Progression Free Survival distribution according to RANO criteria (PFS:
distribution, PFS 6 and PFS 12),
- Overall survival: distribution and OS 24 complete safety profile,
- Patient-oriented criteria: clinical/neurological deterioration free
survival, steroid use, quality of life (by patients and
caregivers/relatives) and development of cognitive deterioration.
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Timepoint(s) of evaluation of this end point: After 6, 12 and 24 months.
Clinical/neurological deterioration free survival, steroid use, quality of
life (by patients and caregivers/relatives) and development of cognitive
deterioration until progression disease.
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Source(s) of Monetary Support
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EORTC
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Roche
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Ethics review
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Status: Approved
Approval date:
Contact:
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