Image Guided Reirradiation of High-grade Glioma

Glioblastoma Clinical Trial

Official title:

Image Guided Reirradiation of High-grade Glioma - a Phase I/II Dose Escalation Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02025231
• Other study ID #: RH ReRT 2011
• Secondary ID: H-2-2011-092
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: December 18, 2013
• Last updated: February 6, 2017
• Start date: December 2011
• Est. completion date: April 2015

Study information

• Verified date: February 2017
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to evaluate the short- and long term toxicity of radiotherapy to patients with recurrent high-grade glioma who have previously received radiotherapy and to determine the best dose and treatment regimen. Positron emission tomography (PET) using an amino acid tracer, 18-fluoro-ethyltyrosine (18F-FET), is used for target delineation.The study examines, in four sequential treatment groups, the effect of dose, hypofractionation and treatment volume on toxicity. Upon completion of the phase I part, the study progresses to phase II where the best dose- and treatment regimen will be chosen for treatment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 31
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• recurrent high-grade glioma

• previous focal radiotherapy for high-grade glioma

• no standard treatment options available/indicated

• ECOG (Eastern Cooperative Oncology Group) performance status 0 or 1 or 2

• life expectancy > 3 months

• hemoglobin value > 6 mmol/l (transfusion permitted)

• able to understand oral and written Danish

Exclusion Criteria:

• disseminated recurrent disease

• infection or wound dehiscence or other pathological condition in meninges/skull/scalp

• symptoms of elevated intracranial pressure

• very early recurrence following primary radiotherapy (< or equal to 3 months)

• contraindications to magnetic resonance imaging (MRI) or positron emission tomography (PET)

• other previous radiotherapy to the brain than primary course of irradiation

Related Conditions & MeSH terms

• Glioblastoma
• Glioma
• Malignant Glioma

Intervention

Radiation:
• External beam radiotherapy
Study group 1: 3.5 Gray x 10, 5 fractions per week. Study group 2: 3.5 Gray x 10 + 7 Gray boost to biological target volume, 5 fractions per week. Study group 3: 5.9 Gray x 10, 5 fractions per week. Study group 4 (planning target volumes: 100 millilitres - 300 millilitres): 3.5 Gray x 10, 5 fractions per week. Phase II dosis: to be chosen based on results of phase I study.

Locations

Country	Name	City	State
Denmark	Department of Radiation Oncology, Rigshospitalet	Copenhagen
Sweden	Skånes universitetssjukhus	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Danish Center for Interventional Research in Radiation Oncology (CIRRO)

Countries where clinical trial is conducted

Denmark,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Toxicity	Early (<4 weeks) and late (> 4 weeks) toxicity evaluated by Common Toxicity Criteria ver. 3.0 at multiple time points up to one year after treatment. (for phase I part of the study)	One year
Primary	Diagnostic precision of 18F-FET-PET imaging in recurrent high-grade glioma	Diagnostic accuracy (positive- and negative predictive value) of 18F-FET-PET guided biopsies (optional procedure) in patients who will receive reirradiation for recurrent high-grade glioma in the study. (for phase I part of the study).	Approximately one to two weeks prior to radiotherapy
Primary	Time to neurocognitive decline	Time to neurocognitive decline assessed using a test battery comprised of validated tests at multiple time points. (for phase II part of the study)	Up to one year
Primary	Time to progression	Time to disease progression evaluated by RANO (Response Assessment in Neuro-Oncology) criteria (for phase II part of the study).	Up to one year
Secondary	Value of 18F-FET-PET in reirradiation of high-grade glioma	Prognostic value of 18F-FET-PET scan at baseline, value of 18F-FET-PET as an early response marker and correlations between 18F-FET-PET scans and magnetic resonance imaging.	One year
Secondary	Objective response rate	Rate of objective tumor responses following treatment evaluated by RANO criteria and by 18F-FET-PET.	Up to one year