Randomized trial assessing the significance of Bevacizumab in recurrent grade II and Grade III gliomas. The TAVAREC trial.

• Register: EUCTR
• Last refreshed on: 5 June 2018
• Main ID: EUCTR2009-017422-39-BE
• Date of registration: 23/09/2010
• Prospective Registration: Yes
• Primary sponsor: European Organisation for Research and Treatment of Cancer (EORTC)
• Public title: Randomized trial assessing the significance of Bevacizumab in recurrent grade II and Grade III gliomas. The TAVAREC trial.
• Scientific title: Randomized trial assessing the significance of Bevacizumab in recurrent grade II and Grade III gliomas. The TAVAREC trial. - TAVAREC
• Date of first enrolment: 28/02/2011
• Target sample size: 155
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-017422-39
• Study type: Interventional clinical trial of medicinal product
• Study design: 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
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Belgium, Germany, Italy, Netherlands, Switzerland, United Kingdom

Contacts

• Name: Project & Regulatory Dept
• Affiliation: European Organisation for Research and Treatment of Cancer (EORTC)

• Name: Project & Regulatory Dept
• Affiliation: European Organisation for Research and Treatment of Cancer (EORTC)

Key inclusion & exclusion criteria

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

Health Condition(s) or Problem(s) studied

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)

Therapeutic area: Diseases [C] - Cancer [C04]

Intervention(s)

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-

Primary Outcome(s)

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.

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.

Primary end point(s): The primary endpoint will be probability of survival at 1 year (i.e. patients alive at 12 months, OS12).

Timepoint(s) of evaluation of this end point: After 12 months

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: After 6, 12 and 24 months.
Clinical/neurological dterioration free survival, steroid use, quality of life (by patients and caregivers/relatives) and development of cognitive deterioration until progression disease.

Secondary end point(s): -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 dterioration free survival, steroid use, quality of life (by patients and caregivers/relatives) and development of cognitive deterioration

Secondary ID(s)

2009-017422-39-NL

26091

Source(s) of Monetary Support

EORTC

Roche