Clinical trial · Interventional
Short Course of Radiation for Gliomas in Elderly Patients
A Phase II Study of Hypofractionated Radiation With CyberKnife Stereotactic Radiosurgery Boost for High Grade Gliomas in Elderly Patients With Good Performance Status
NCT00386919CI-TRIAL-00025673completedPhase 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)
Patients with high grade brain tumors will be treated to test shortened course of radiation therapy with the use of precise, focused radiation with cyberknife.
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 |
|---|---|---|---|
| High Grade Gliomas | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CyberKnife | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- To assess the tolerability of short duration involved field radiation followed by CyberKnife Radiosurgery Boost
- timeFrame
- 1 month
Secondary outcomes (1)
- measure
- Assessment of local control rate, progression free survival, overall survival, quality of life and toxicity and steroid dependence in this population with this regime
- timeFrame
- 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically confirmed High Grade Glioma (oligo-, astro- or mixed gliomas). * \>65 years of age * KPS\>70 * No contraindication for Radiation or Chemotherapy * Histopathologically confirmed newly diagnosed glioblastoma multiforme or Anaplastic Glioma (WHO Grade III) by surgical excision or biopsy. * Patient must have recovered from the effects of surgery, post-operative infection, or other complications. * Therapy should start within 5 weeks of surgery * Must have an estimated survival of \> 8 weeks. * KPS \> 70. * Age \> 65 years. * Must have a pre- and post operative contrast enhanced MRI scans * Laboratory values within the following limits: ANC (absolute neutrophil count) \>/= 1.5x 109/l, Platelets \>/= 100x 10 9 /L, Hemoglobin \>/= 9g/dl, Serum Creatinine \>/= 1.5mg/dl., Serum total Bilirubin \</= 1.5 x upper limit of normal (ULN), SGOT/SGPT \</= 2.5x ULN, Albumin \>/= 3g/dl. * If the patient receiving an enzyme inducing antiepileptic drug will be switched to an NEIAED (Non Enzyme Inducing Anti Epileptic Drug). Exclusion Criteria: * Histology grade less than Anaplastic Glioma ( WHO Grade III). * Recurrent malignant glioma. * Tumor involving the Brain stem. * Any detected tumor foci beyond the cranial vault. * Major medical or psychiatric illness, which in the investigator's opinion will prevent administration or completion of the protocol therapy. * Prior malignancies, except for non-melanomatous skin cancers, or carcinoma in situ of uterus, cervix or bladder, unless disease free for \> 5 years. * Prior radiation to the head or neck (except for T1 glottic cancer) resulting in overlap of radiation fields. * Prior chemotherapy for the current disease.
References
Publications (0)
Data not yet available
No reference posted for this study.