Status:
UNKNOWN
Adjuvant Stereotactic Fractionated Radiotherapy to the Resection Cavity in Recurrent Glioblastoma
Lead Sponsor:
Technical University of Munich
Collaborating Sponsors:
Helmholtz Zentrum München
Conditions:
Glioblastoma
Eligibility:
All Genders
18-99 years
Phase:
PHASE2
Brief Summary
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 prog...
Detailed Description
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 con...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2023
Estimated Enrollment :
162 Patients enrolled
Trial Details
Trial ID
NCT02715297
Start Date
February 1 2016
End Date
February 1 2023
Last Update
March 10 2020
Active Locations (1)
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1
Dept. Radiation Oncology
Munich, Bavaria, Germany, 81675