Clinical trial · Interventional
Temozolomide Plus Bevacizumab in Supratentorial Glioblastoma in 70 Years and Older Patients With an Impaired Functional Status
Temozolomide Plus Bevacizumab Chemotherapy in Supratentorial Glioblastoma in 70 Years and Older Patients With an Impaired Functional Status (KPS<70)
NCT02898012CI-TRIAL-00023845ATAGcompletedPhase 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 optimal treatment of glioblastoma multiforme (GBM) in patients aged ≥70 years with a Karnofsky performance status (KPS) \<70 is unestablished. This clinical trial evaluated the efficacy and safety of upfront temozolomide (TMZ) and bevacizumab (Bev) in patients aged ≥70 years and a KPS \<70.
Conditions
Conditions (2)
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 Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
| Primary Brain Tumor | Primary Brain Tumor | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Temozolomide and Bevacizumab
- description
- Single experimental arm with two drugs : Temozolomide and Bevacizumab
- interventionNames
- Drug: Temozolomide
- Drug: Bevacizumab
Primary outcomes (1)
- measure
- Median Overall Survival (OS)
- timeFrame
- OS calculated from the date of surgery until death or up to 36 months.
- description
- OS calculated from the date of surgery until death from any cause or up to 36 months.
Secondary outcomes (6)
- measure
- Progression-free survival (PFS)
- timeFrame
- PFS calculated from the date of surgery until the date of first documented progression or up to 36 months.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Supratentorial Glioblastoma diagnosed by biopsy. * Patients aged ≥ 70 years * KPS \>30 and \< 70 * Life expectancy \> or = 8 weeks * Patients were enrolled at least 14 days after stereotactic biopsy and 28 days after surgical biopsy. * CT or brain MRI was performed within 4 weeks before treatment to rule out haemorrhage. * Included to health social security system * Medical assessment previous to inclusion * Informed consent form Exclusion Criteria: * Previous treatment with Surgical resection, RT or chemotherapy to the tumor. * Hemoglobin level \< 9 g% * Absolute neutrophil count \< 1500 * Platelet count \< 100.000 * ASAT or ALAT levels more than 3 times the upper limit of normal. * Bilirubin levels more than 2 times the upper limit of normal * Creatinin more than 1.5 times the upper limit of normal * Untreated high blood pressure \>150/100 mmHg * Congestive cardiac failure * Proteinuria \> 1 gr/24h * INR \> 1.5 the upper limit of normal * Recent symptomatic haemorrhage * History of abnormal wound healing * Gastrointestinal fistula * Haemoptysis \> grade 2 (NCI-CTC) * Intracranial abscess * Coagulation disorder * Active infection requiring intravenous antibiotics * Vascular disease (including myocardial infarction, unstable angina, cerebrovascular disease, peripheral arterial or aortic disease) in the previous 6 months * Malignancy diagnosed in the previous 5 years (except basocellular skin cancer and in situ cervix cancer) * Allergy to dacarbazine, Bevacizumab, Temozolomide or their excipients, recombinant human monoclonal antibodies, or ovarian cells of Chinese hamsters.
References
Publications (20)
- BACKGROUNDDolecek TA, Propp JM, Stroup NE, Kruchko C. CBTRUS statistical report: primary brain and central nervous system tumors diagnosed in the United States in 2005-2009. Neuro Oncol. 2012 Nov;14 Suppl 5(Suppl 5):v1-49. doi: 10.1093/neuonc/nos218. No abstract available. PMID 23095881
- BACKGROUNDFleury A, Menegoz F, Grosclaude P, Daures JP, Henry-Amar M, Raverdy N, Schaffer P, Poisson M, Delattre JY. Descriptive epidemiology of cerebral gliomas in France. Cancer. 1997 Mar 15;79(6):1195-202. doi: 10.1002/(sici)1097-0142(19970315)79:63.0.co;2-v. PMID 9070498
- BACKGROUNDKeime-Guibert F, Chinot O, Taillandier L, Cartalat-Carel S, Frenay M, Kantor G, Guillamo JS, Jadaud E, Colin P, Bondiau PY, Menei P, Loiseau H, Bernier V, Honnorat J, Barrie M, Mokhtari K, Mazeron JJ, Bissery A, Delattre JY; Association of French-Speaking Neuro-Oncologists. Radiotherapy for glioblastoma in the elderly. N Engl J Med. 2007 Apr 12;356(15):1527-35. doi: 10.1056/NEJMoa065901. PMID 17429084
- BACKGROUNDMalmstrom A, Gronberg BH, Marosi C, Stupp R, Frappaz D, Schultz H, Abacioglu U, Tavelin B, Lhermitte B, Hegi ME, Rosell J, Henriksson R; Nordic Clinical Brain Tumour Study Group (NCBTSG). Temozolomide versus standard 6-week radiotherapy versus hypofractionated radiotherapy in patients older than 60 years with glioblastoma: the Nordic randomised, phase 3 trial. Lancet Oncol. 2012 Sep;13(9):916-26. doi: 10.1016/S1470-2045(12)70265-6. Epub 2012 Aug 8. PMID 22877848
- BACKGROUNDWick W, Platten M, Meisner C, Felsberg J, Tabatabai G, Simon M, Nikkhah G, Papsdorf K, Steinbach JP, Sabel M, Combs SE, Vesper J, Braun C, Meixensberger J, Ketter R, Mayer-Steinacker R, Reifenberger G, Weller M; NOA-08 Study Group of Neuro-oncology Working Group (NOA) of German Cancer Society. Temozolomide chemotherapy alone versus radiotherapy alone for malignant astrocytoma in the elderly: the NOA-08 randomised, phase 3 trial. Lancet Oncol. 2012 Jul;13(7):707-15. doi: 10.1016/S1470-2045(12)70164-X. Epub 2012 May 10. PMID 22578793
- Gallego Perez-Larraya J, Ducray F, Chinot O, Catry-Thomas I, Taillandier L, Guillamo JS, Campello C, Monjour A, Cartalat-Carel S, Barrie M, Huchet A, Beauchesne P, Matta M, Mokhtari K, Tanguy ML, Honnorat J, Delattre JY. Temozolomide in elderly patients with newly diagnosed glioblastoma and poor performance status: an ANOCEF phase II trial. J Clin Oncol. 2011 Aug 1;29(22):3050-5. doi: 10.1200/JCO.2011.34.8086. Epub 2011 Jun 27.