Avastin Plus Radiotherapy in Elderly Patients With Glioblastoma

NCT01443676 | Completed Phase 2 DMC

• 1 other identifier: ARTE
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to explore the efficacy of bevacizumab combined with radiotherapy compared with radiotherapy alone in the treatment of newly diagnosed glioblastoma in the elderly.

• Trial with medicinal product

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• median overall survival

  median overall survival

  1 year

Secondary Outcomes (1)

• progression-free survival

  progression-free survival after 6 months

Study Arms (2)

Radiotherapy

ACTIVE COMPARATOR

Radiotherapy

Radiation: Radiation therapy

Radiotherapy plus Bevacizumab

EXPERIMENTAL

Radiotherapy plus Bevacizumab

Drug: Bevacizumab

Interventions

Bevacizumab DRUG

Bevacizumab will be added to radiotherapy

Also known as: Avastin

Radiotherapy plus Bevacizumab

Radiation therapy RADIATION

Radiation therapy

Radiotherapy

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Signed informed consent
• Age \> 65 years
• Newly diagnosed supratentorial glioblastoma
• Eligible for first infusion of bevacizumab \> 28 and \> 49 days after surgery for glioblastoma
• Karnofsky performance score 60 or more
• Paraffin-embedded tissue for central pathology review
• Stable or decreasing corticosteroid dose within 5 days prior to enrolment
• Adequate haematological function:
• Adequate liver function
• Adequate renal function

You may not qualify if:

• Karnofsky performance score 50 or less
• Evidence of recent hemorrhage on postoperative brain MRI
• Tumor with infiltration of retina, optic nerve, optic chiasm or brainstem
• Any prior chemotherapy including carmustine-containing wafers (Gliadel®) or immunotherapy for glioblastoma or lower grade astrocytomas
• Any prior radiotherapy to the brain or prior radiotherapy resulting in a potential overlap in the radiation field
• Inadequately controlled hypertension
• History of hypertensive crisis or hypertensive encephalopathy
• New York Heart Association (NYHA) grade II or higher congestive heart failure
• Myocardial infarction or unstable angina within 6 months prior to enrolment
• Stroke or transitory ischemic attack within 6 months prior to enrolment
• Other significant vascular disease within 6 months prior to enrolment
• History of = grade 2 haemoptysis within 1 month prior to enrolment
• Bleeding diathesis or coagulopathy in the absence of therapeutic anticoagulation
• Major surgical procedure, open biopsy, intracranial biopsy, ventriculoperitoneal shunt or significant traumatic injury within 28 days prior to first dose of bevacizumab
• Core biopsy (excluding intracranial biopsy) or other minor surgical procedure within 7 days prior to first dose of bevacizumab

Sponsors & Collaborators

• University of Zurich: lead

Study Sites (1)

Department of Neurology, University Hospital Zurich

Zurich, Switzerland

Location

Related Publications (2)

• Wirsching HG, Roelcke U, Weller J, Hundsberger T, Hottinger AF, von Moos R, Caparrotti F, Conen K, Remonda L, Roth P, Ochsenbein A, Tabatabai G, Weller M. MRI and 18FET-PET Predict Survival Benefit from Bevacizumab Plus Radiotherapy in Patients with Isocitrate Dehydrogenase Wild-type Glioblastoma: Results from the Randomized ARTE Trial. Clin Cancer Res. 2021 Jan 1;27(1):179-188. doi: 10.1158/1078-0432.CCR-20-2096. Epub 2020 Sep 23.

  PMID: 32967939 DERIVED

• Wirsching HG, Tabatabai G, Roelcke U, Hottinger AF, Jorger F, Schmid A, Plasswilm L, Schrimpf D, Mancao C, Capper D, Conen K, Hundsberger T, Caparrotti F, von Moos R, Riklin C, Felsberg J, Roth P, Jones DTW, Pfister S, Rushing EJ, Abrey L, Reifenberger G, Held L, von Deimling A, Ochsenbein A, Weller M. Bevacizumab plus hypofractionated radiotherapy versus radiotherapy alone in elderly patients with glioblastoma: the randomized, open-label, phase II ARTE trial. Ann Oncol. 2018 Jun 1;29(6):1423-1430. doi: 10.1093/annonc/mdy120.

  PMID: 29648580 DERIVED

MeSH Terms

Conditions

Glioblastoma

Interventions

Bevacizumab; Radiotherapy

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Therapeutics

Study Officials

• 01 Studienregister MasterAdmins

  UniversitaetsSpital Zuerich

  STUDY DIRECTOR

• Michael Weller, Professor

  University Hospital Zurich, Division of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2011
• First Posted: September 30, 2011
• Study Start: October 1, 2011
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2016
• Last Updated: November 1, 2016

Record last verified: 2016-10

Locations

CH (1)