Clinical trial · Interventional
A Phase III Study of Re-Irradiation in Recurrent Glioblastoma
A Randomized Phase III Study of Re-Irradiation in Recurrent Glioblastoma
NCT01830101CI-TRIAL-00021375withdrawnPhase 3ClinicalTrials.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): This study will not be proceeding due to lack of funding from anticipated sources
Summary
Brief summary (as posted)
The investigators hope to improve overall median survival of patients with recurrent Glioblastoma by investigating continuous low-dose daily Temozolomide plus or minus five treatments of re-irradiation.
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 |
|---|---|---|---|
| Recurrent Glioblastoma | Glioblastoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Temozolomide | Drug | Temozolomide | ALIAS |
| TMZ plus concurrent re-irradiation | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- TMZ plus concurrent re-irradiation
- description
- TMZ plus concurrent re-irradiation
- interventionNames
- Drug: TMZ plus concurrent re-irradiation
- Drug: Temozolomide
- type
- EXPERIMENTAL
- label
- TMZ alone
- description
- TMZ alone
- interventionNames
- Drug: TMZ plus concurrent re-irradiation
- Drug: Temozolomide
Primary outcomes (1)
- measure
- To determine the overall median survival of the combination of continuous dose-intense temozolomide with or without re-irradiation in patients with recurrent glioblastoma.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * histologically-proven intracranial glioblastoma or gliosarcoma previously treated with concurrent chemoradiation * radiographic evidence of tumour progression or recurrence * 18 years or older * ECOG 0 - 2 * signed informed consent form Exclusion Criteria: * tumour progression or recurrence within 3 months of initial concurrent chemoradiation * 6 or more cycles of TMZ administered following chemoradiation at initial diagnosis * more than one prior course of salvage chemo for recurrent disease * prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for greater or equal to 3 years * prior head or neck RT except for T1 glottic cancer
References
Publications (0)
Data not yet available
No reference posted for this study.