Clinical trial · Interventional
Dose Escalation Radiotherapy With Modulation of Intensity and Integrated Boost (SIB-IMRT) in the Treatment of Glioblastomas in Adults
Dose Escalation Radiotherapy With Modulation of Intensity and Integrated Boost in Association With a Temozolomide in the Treatment of Glioblastoma
NCT01043536CI-TRIAL-00008127SIB-IMRTcompletedPhase 1ClinicalTrials.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 main goal of this study is to evaluate and to determine the dose of a highly accurate irradiation (allowing to increase the dose delivered while restricting the risk of complication) in association with temozolomide.
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 |
|---|---|---|---|
| radiotherapy | Radiation | — | UNRESOLVED |
| temozolomide | Drug | Temozolomide | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- radiotherapy + temozolomide
- description
- Radiotherapy: dose given at PTV-g will be 70 Gy/28 fractions level 1 75 Gy/30 fractions level 2 80 Gy/32 fractions level 3 dose given at PTV-a will be 56 Gy/28 fractions level 1 60 Gy/30 fractions level 2 60.8 Gy/32 fractions level 3 Chemotherapy: temozolomide given at the dose of 75mg/m2
- interventionNames
- Radiation: radiotherapy
- Drug: temozolomide
Primary outcomes (1)
- measure
- To determine the OTR (optimal tolerated regimen) of radiotherapy administered in combination with temozolomide as first-line therapy in patients with de novo glioblastoma
- timeFrame
- 3 months after the start of the radiotherapy
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathologically proven diagnosis of glioblastoma (WHO grade IV astrocytoma) * Diagnosis must be obtained by a stereotactic or surgical biopsy * Age between 18 and 70 * Total or partial surgical resection deemed as not possible by a neurosurgeon * OMS performance status 0 or 1 * Adequate blood function : absolute neutrophil count \> 1.5 x 109/L, platelets count \> 100 x 109/L platelets; * Adequate liver function: bilirubin \< 1.5 ULN (upper limit of normal), ALT and AST \< 3 ULN, * Adequate renal function: creatinine \< 1.5 ULN * Patient must have been informed and must have signed the specific informed consent form. Exclusion Criteria: * other malignancy histology * resection of the brain tumor complete on MRI exploration * patient unable to give informed consent * patient presenting counter-indication to MRI exploration * patient must not have received neither radiotherapy nor chemotherapy for that affection * concomitant malignancy * patient already enrolled in another biomedical study with an experimental molecule * pregnant, nursing woman, or without contraception * private individuals of freedom or under tutelage (including legal guardianship) * psychiatric, behavioural disorders or geographical situation precluding the administration or follow-up of the protocol (including claustrophobia)
References
Publications (0)
Data not yet available
No reference posted for this study.