Clinical trial · Interventional
Avastin Plus Radiotherapy in Elderly Patients With Glioblastoma
NCT01443676CI-TRIAL-00024545ARTEcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Radiotherapy
- description
- Radiotherapy
- interventionNames
- Radiation: Radiation therapy
- type
- EXPERIMENTAL
- label
- Radiotherapy plus Bevacizumab
- description
- Radiotherapy plus Bevacizumab
- interventionNames
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- median overall survival
- timeFrame
- 1 year
- description
- median overall survival
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion criteria: Diagnosis: newly diagnosed glioblastoma in elderly patients 1. Signed informed consent 2. Age \> 65 years 3. Newly diagnosed supratentorial glioblastoma 4. Eligible for first infusion of bevacizumab \> 28 and \> 49 days after surgery for glioblastoma 5. Karnofsky performance score 60 or more 6. Paraffin-embedded tissue for central pathology review 7. Stable or decreasing corticosteroid dose within 5 days prior to enrolment 8. Adequate haematological function: 9. Adequate liver function 10. Adequate renal function Exclusion criteria: 1. Karnofsky performance score 50 or less 2. Evidence of recent hemorrhage on postoperative brain MRI 3. Tumor with infiltration of retina, optic nerve, optic chiasm or brainstem 4. Any prior chemotherapy including carmustine-containing wafers (Gliadel®) or immunotherapy for glioblastoma or lower grade astrocytomas 5. Any prior radiotherapy to the brain or prior radiotherapy resulting in a potential overlap in the radiation field 6. Inadequately controlled hypertension 7. History of hypertensive crisis or hypertensive encephalopathy 8. New York Heart Association (NYHA) grade II or higher congestive heart failure 9. Myocardial infarction or unstable angina within 6 months prior to enrolment 10. Stroke or transitory ischemic attack within 6 months prior to enrolment 11. Other significant vascular disease within 6 months prior to enrolment 12. History of = grade 2 haemoptysis within 1 month prior to enrolment 13. Bleeding diathesis or coagulopathy in the absence of therapeutic anticoagulation 14. Major surgical procedure, open biopsy, intracranial biopsy, ventriculoperitoneal shunt or significant traumatic injury within 28 days prior to first dose of bevacizumab 15. Core biopsy (excluding intracranial biopsy) or other minor surgical procedure within 7 days prior to first dose of bevacizumab 16. Abdominal fistula or gastrointestinal perforation within 6 months prior to enrolment 17. Intracranial abscess within 6 months prior to enrolment 18. Serious non-healing wound, active ulcer or untreated bone fracture 19. Pregnancy or lactation 20. Fertile women \< 2 years after last menstruation and men unwilling or unable to use effective means of contraception 21. Active malignancy that may interfere with the study treatment at the investigator?s and PI discretion
References
Publications (2)
- DERIVEDWirsching 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
- DERIVEDWirsching 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