Clinical trial · Interventional
Adjuvant Stereotactic Fractionated Radiotherapy to the Resection Cavity in Recurrent Glioblastoma
NCT02715297CI-TRIAL-00043904GlioCave/NOA17unknownPhase 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)
This multi-center randomized controlled phase II trial will investigate the impact of stereotactic fractionated radiotherapy to the resection cavity of complete resected recurrent glioblastoma on progression free survival. As secondary endpoints, overall survival, safety and toxicity as well as early response criteria on MRI, quality of life and neurocognitive function will be assessed. Chemotherapy will not be part of the protocol, however, additional treatment will be possible upon investigators best choice.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SRT to the resection cavity | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: SRT to the resection cavity
- description
- Postoperative stereotactic fractionated radiotherapy (SRT) to the resection cavity to a Total Dose of 46 Gy, 2 Gy single dose, or 36 Gy in 3 Gy single dose 5 fractions/week, depending on the volume and location of the treatment region.
- interventionNames
- Radiation: SRT to the resection cavity
- type
- NO_INTERVENTION
- label
- Arm B: Observation
- description
- Observation without adjuvant radiotherapy.
Primary outcomes (1)
- measure
- Progression free survival (PFS) at 12 months
- timeFrame
- 1 year
- description
- PFS will be defined according to the MacDonald and RANO-Criteria; Complete remission: Remission of all contrast-enhanced lesions on CT or MRI without worsening of neurologic status Partial remission: at least 50% remission of the contrast-enhancing lesions on CT or MRI without increase in steroid medication and without worsening of the neurologic status Stable disease: Remission of the solid tumor/contrast-enhancing lesion on CT or MRI of less than 50% or progression of the solid tumor/contrast-enhancing lesion on CT or MRI of less than 25%, without increase in steroid medication of worsening of the neurologic status Progression: Increase in solid tumor/contrast-enhancing lesion of 25% or more or development of a new lesion
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Unifocal, supratentorial recurrent glioblastoma * Prior course of standard treatment * Complete resection of all contrast enhancing areas * age ≥ 18 years of age * Karnofsky Performance Score 60% or higher * For women with childbearing potential, (and men) adequate contraception. * Ability of subject to understand character and individual consequences of the clinical trial * Written informed consent (must be available before enrolment in the trial) Exclusion Criteria: * Multifocal glioblastoma of gliomatosis cerebri * Time interval of less than 6 months after primary radiotherapy * Previous re-irradiation or prior radiosurgery of prior treatment with interstitial radioactive seeds * refusal of the patients to take part in the study * Patients who have not yet recovered from acute toxicities of prior therapies * Known carcinoma \< 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy * Pregnant or lactating women * Participation in another clinical study or observation period of competing trials, respectively.
References
Publications (1)
- DERIVEDStraube C, Scherb H, Gempt J, Kirschke J, Zimmer C, Schmidt-Graf F, Meyer B, Combs SE. Adjuvant stereotactic fractionated radiotherapy to the resection cavity in recurrent glioblastoma - the GlioCave study (NOA 17 - ARO 2016/3 - DKTK ROG trial). BMC Cancer. 2018 Jan 3;18(1):15. doi: 10.1186/s12885-017-3928-7. PMID 29298660