Clinical trial · Interventional
Hypofractionated Stereotactic Radiotherapy for Patients With Recurrent High Grade Glioma
Phase II Study of Hypofractionated Stereotactic Radiotherapy for Patients With Recurrent High Grade Glioma
NCT02567539CI-TRIAL-00060864completedN/AClinicalTrials.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 study is aimed to evaluate efficacy and safety of re-irradiation for patients with recurrent high grade gliomas after other treatment.
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 High Grade Glioma | High-Grade Glioma, NOS | CURATED_BROADER | 0.78 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| IMRT with or without radiosensitive therapy | Radiation | — | UNRESOLVED |
| Radiosensitive therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Recurrent high grade glioma
- description
- IMRT with or without radiosensitive therapy
- interventionNames
- Radiation: IMRT with or without radiosensitive therapy
- Drug: Radiosensitive therapy
Primary outcomes (2)
- measure
- Progression free of participants
- timeFrame
- 4 years
- measure
- Overall survival of participants
- timeFrame
- 4 years
Secondary outcomes (2)
- measure
- Incidence of radionecrosis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years * Karnosky performance status (KPS) ≥70 * Patients aged \>70 years with KPS ≥80 * Histopathologically confirmed grade III-IV glioma * Estimated survival ≥ 3 months * Any Tumor volume * Unifocal tumor * Interval time from previous radiotherapy ≥ 6mesi * Normal liver, Kidney and bone marrow function * Written informed consent Exclusion Criteria: * KPS \< 70 * Multifocal tumor * Other primary cancer * Pregnant women
References
Publications (3)
- RESULTNavarria P, Ascolese AM, Tomatis S, Reggiori G, Clerici E, Villa E, Maggi G, Bello L, Pessina F, Cozzi L, Scorsetti M. Hypofractionated Stereotactic Radiation Therapy in Recurrent High-Grade Glioma: A New Challenge. Cancer Res Treat. 2016 Jan;48(1):37-44. doi: 10.4143/crt.2014.259. Epub 2015 Feb 23. PMID 25761491
- RESULTScorsetti M, Navarria P, Pessina F, Ascolese AM, D'Agostino G, Tomatis S, De Rose F, Villa E, Maggi G, Simonelli M, Clerici E, Soffietti R, Santoro A, Cozzi L, Bello L. Multimodality therapy approaches, local and systemic treatment, compared with chemotherapy alone in recurrent glioblastoma. BMC Cancer. 2015 Jun 30;15:486. doi: 10.1186/s12885-015-1488-2. PMID 26118437
- DERIVEDNavarria P, Pessina F, Clerici E, Bellu L, Franzese C, Franzini A, Simonelli M, Bello L, Santoro A, Politi LS, D'agostino GR, Casarotti A, Fernandes B, Torri V, Scorsetti M. Re-irradiation for recurrent high grade glioma (HGG) patients: Results of a single arm prospective phase 2 study. Radiother Oncol. 2022 Feb;167:89-96. doi: 10.1016/j.radonc.2021.12.019. Epub 2021 Dec 22. PMID 34952000