Clinical trial · Observational
Re-irradiation of High Grade Gliomas: a Quality of Life Study
NCT01711580CI-TRIAL-00017866withdrawnClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Another study was commenced for this patient group
Summary
Brief summary (as posted)
Patients with a high grade glioma have an increasing overall survival and progression free survival after initial treatment. Because of a better performance status these patients are more often eligible for re-treatment with for example radiotherapy. However, to date only a few prospective studies on re-irradiation of gliomas exist and very little is known about the effects of re-irradiation on quality of life and cognition. This trial is designed to longitudinally establish the effects of re-irradiation on quality of life, cognition and physical performance in patients with a high grade glioma. Based on the currently available information the investigators hypothesize that quality of life after re-irradiation can be kept stable until further tumour progression.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anaplastic Astrocytoma | Anaplastic Astrocytoma | CURATED_BROADER | 0.80 |
| Anaplastic Oligoastrocytoma | Anaplastic Oligoastrocytoma | CURATED_BROADER | 0.80 |
| Glioblastoma Multiforme | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (8)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Controlled oral word association test (COWA) | Other | — | UNRESOLVED |
| EORTC QLQ-BN20 | Other | — | UNRESOLVED |
| EORTC QLQ-C30 | Other | — | UNRESOLVED |
| EORTC QLQ- FA13 | Other | — | UNRESOLVED |
| Hopkins Verbal Learning Test-Revised (HVLT-R) | Other | — | UNRESOLVED |
| Jamar hand dynamometer | Other | — | UNRESOLVED |
| Stroop color-word test | Other | — | UNRESOLVED |
| Trail Making Test (TMT) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Re-irradiation, high grade glioma
- description
- EORTC QLQ-C30 EORTC QLQ-BN20 Hopkins Verbal Learning Test-Revised (HVLT-R) Trail Making Test (TMT) Stroop color-word test Controlled oral word association test (COWA) Jamar hand dynamometer EORTC QLQ- FA13 Short Form health survey (SF-36)
- interventionNames
- Other: EORTC QLQ-C30
- Other: EORTC QLQ-BN20
- Other: Hopkins Verbal Learning Test-Revised (HVLT-R)
- Other: Stroop color-word test
- Other: Controlled oral word association test (COWA)
- Other: Jamar hand dynamometer
- Other: EORTC QLQ- FA13
- Other: Trail Making Test (TMT)
Primary outcomes (1)
- measure
- Change from baseline in the palliative effect of re-irradiation in patients with a high grade glioma, defined by quality-of-life parameters
- timeFrame
- baseline, 6-8weeks, 12 weeks, 18-20 weeks, 30-32 weeks
- description
- These Quality of life parameters include: * The change in the EORTC QLQ-C30 score from baseline to endpoint * The change in the EORTC QLQ-BN20 score from baseline to endpoint * The change in the EORTC QLQ-FA13 score from baseline to endpoint * The change in cognition from baseline to endpoint as measured by the HVLT-R, the TMT, the Stroop-test and the COWA * The change in grip strength from baseline to endpoint
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically proven high-grade glioma anaplastic astrocytoma or glioblastoma * Age ≥ 18 years * WHO performance status ≤ 2 * Scheduled for re-irradiation of a high grade glioma * The patient is willing and capable to comply with study procedure Exclusion Criteria: • Life expectancy \< 3 months
References
Publications (23)
- BACKGROUNDStupp R, Mason WP, van den Bent MJ, Weller M, Fisher B, Taphoorn MJ, Belanger K, Brandes AA, Marosi C, Bogdahn U, Curschmann J, Janzer RC, Ludwin SK, Gorlia T, Allgeier A, Lacombe D, Cairncross JG, Eisenhauer E, Mirimanoff RO; European Organisation for Research and Treatment of Cancer Brain Tumor and Radiotherapy Groups; National Cancer Institute of Canada Clinical Trials Group. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005 Mar 10;352(10):987-96. doi: 10.1056/NEJMoa043330. PMID 15758009
- BACKGROUNDNieder C, Adam M, Molls M, Grosu AL. Therapeutic options for recurrent high-grade glioma in adult patients: recent advances. Crit Rev Oncol Hematol. 2006 Dec;60(3):181-93. doi: 10.1016/j.critrevonc.2006.06.007. Epub 2006 Jul 27. PMID 16875833
- BACKGROUNDVeninga T, Langendijk HA, Slotman BJ, Rutten EH, van der Kogel AJ, Prick MJ, Keyser A, van der Maazen RW. Reirradiation of primary brain tumours: survival, clinical response and prognostic factors. Radiother Oncol. 2001 May;59(2):127-37. doi: 10.1016/s0167-8140(01)00299-7. PMID 11325440
- BACKGROUNDHudes RS, Corn BW, Werner-Wasik M, Andrews D, Rosenstock J, Thoron L, Downes B, Curran WJ Jr. A phase I dose escalation study of hypofractionated stereotactic radiotherapy as salvage therapy for persistent or recurrent malignant glioma. Int J Radiat Oncol Biol Phys. 1999 Jan 15;43(2):293-8. doi: 10.1016/s0360-3016(98)00416-7. PMID 10030252
- BACKGROUNDCho KH, Hall WA, Gerbi BJ, Higgins PD, McGuire WA, Clark HB. Single dose versus fractionated stereotactic radiotherapy for recurrent high-grade gliomas. Int J Radiat Oncol Biol Phys. 1999 Dec 1;45(5):1133-41. doi: 10.1016/s0360-3016(99)00336-3. PMID 10613305
- BACKGROUNDErnst-Stecken A, Ganslandt O, Lambrecht U, Sauer R, Grabenbauer G. Survival and quality of life after hypofractionated stereotactic radiotherapy for recurrent malignant glioma. J Neurooncol. 2007 Feb;81(3):287-94. doi: 10.1007/s11060-006-9231-0. Epub 2006 Sep 20.