A Phase 2 interventional study of SRT to the resection cavity in Glioblastoma, sponsored by Technical University of Munich. Status unknown at 1 site in Germany. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2020-03-10.
Sponsored by Technical University of Munich · Phase 2, Interventional, and Treatment
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.
The treatment of recurrent glioblastoma is, beside of its abundance in clinical practice, still under discussion. Patients presenting with recurrent disease are therefore treated within individual concepts, largely based on small prospective trials, retrospective evaluations or case reports. Therefore, the treatment ranges from best supportive care over primary systemic treatments towards local therapies such as radiotherapy or surgical resection. Even if there might be a large selection bias, local therapies with or without concomitant or adjuvant chemotherapy seem to promise the largest prognostic benefit. Whether the combination of surgical resection and adjuvant radiotherapy improves survival, as it does within the primary situation, is unknown.
The result of surgical resection might have an impact as well. Several case reports, retrospective evaluations and prospective studies have also included patients with remaining gross tumor after maximum save resection. In these trials, radiotherapy was associated with improvements in progression free as well as overall survival. Therefore, the influence of neuroimaging on prognosis is currently evaluated within the GLIA-A trial. Furthermore, stereotactic radiotherapy with or without an experimental systemic therapy is currently investigated within another multicenter randomized trial (NOA-12).
Whether patients might benefit from a postoperative radiotherapy of the resection cavity after complete extirpation of all macroscopic tumor is key question of this protocol.
To answer this question, the considered standard of care after complete resection, namely observation with or without adjuvant systemic therapy, will be compared to a postoperative normofractionated stereotactic radiotherapy towards the resection cavity within an open label, randomized trial. The prescribed total dose will be 46 Gy in 2 Gy fractions of 36 Gy in 3 Gy fractions depending on the treatment volume.
Concerning safety, side effects will be monitored prospectively. Safety parameters will be compared between both arms of the study. Furthermore, measures for quality of life, neurocognitive function as well as neuroimaging features will be evaluated prospectively.
1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.
This study's planned enrollment of 162 is above the median of 36 across 1,618 interventional studies indexed under Glioblastoma.
Browse Glioblastoma studies →Technical University of Munich is the lead sponsor of 315 studies on the registry; 55 are open to participants now.
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Exclusion Criteria:
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.
Radiation: SRT to the resection cavity
Observation without adjuvant radiotherapy.
46 Gy total dose will be delivered in 2 Gy per fraction, or 36 Gy delivered in 3 Gy per fraction, 5 fractions within 1 week. Doses will have to cover 95% of the PTV with the prescribed dose. The clinical target volume (CTV) will be defined as the resection cavity of the recurrent glioblastoma plus a margin of 5mm. A CTV to PTV margin of 1 to 3mm will be added according to technique used for immobilisation.
Progression free survival (PFS) at 12 months
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
Time frame: 1 year
Overall survival
Patients will be followed up until death or for at least 1 year. Living patients will be censored according to the date of their last visit.
Time frame: 1 year
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Safety and tolerability will be assessed by quality and quantity according to the International Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 for toxicity and adverse event reporting. Safety and toxicity of the study treatment will be evaluated by clinical neurological examination as well as neuro-imaging studies (MRI or CT).
Time frame: 1 year
Quality of Life questionnaire
The EORTC QLQ-C30 version 3.0 questionnaire will be used to monitor for Quality of Life continuously throughout the treatment course as well as during follow up.
Time frame: 1 year
Neurocognitive function
Neurocognitive function will be assessed at randomisation, at 6 months and at 12 months after randomization. A battery containing of 3 tests will be used. For assessment of learning, early and intermediate recall, the German version of the California Verbal Learning Test (CVLT) as well as the Regensburger Wortflüssigkeits-Test (RWT) will be used. Cognitive flexibility, speed as well as attention will be tested by the Trail-Making-Test. The tests at 6 and at 12 months will be compared to the result of the baseline measure as well as to each other.
Time frame: 1 year
Plan to share: No
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Technical University of Munich