NCT01464177CompletedPhase 2
Hypofractionated Stereotactic Radiotherapy in Recurrent Glioblastoma Multiforme
Prospective Randomized Phase II Trial of Hypofractionated Stereotactic Radiotherapy in Recurrent Glioblastoma Multiforme
Source: ClinicalTrials.gov · Last updated 9 Dec 2024
Brief summary (registry, in English)
Glioblastoma multiforme (GBM) is the most common primary brain tumor in adults. The treatment comprises maximal safe resection followed by radiotherapy and chemotherapy. Despite appropriate management, 90% of the patients will develop relapse or progression. After progression, the median survival is 5.2 months (Stupp, 2009). The treatment of GBM relapse remains investigational. Reirradiation is an option in selected cases. The objective of this study is to compare 2 schemes of stereotactic hypofractionated radiotherapy in the management of recurrent GBM.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 25 Oct 2011
- Start date
- 1 Oct 2011
- Primary completion date
- 31 Jul 2021
- Lead sponsor
- Andre Tsin Chih Chen
- Diseases
- Glioblastoma
- NCT number
- NCT01464177
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 40
- From 1 Oct 2011 to the primary completion date, 31 Jul 2021
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concomitant chemotherapy
Other
- Important comorbidities
- Contraindication to MRI
- Brainstem glioma
Who the study is looking for
- 18 years of age or older
- KPS equal or greater than 60
- Anatomopathological confirmation of GBM
- Previous RT with therapeutic doses
- At least 5 months from the end of RT course
- Not a candidate to surgical resection
- Patients with partial resection after resection of recurrent GBM will be allowed
- Patients with local progression after resection of recurrent GBM will be allowed
- Lesion with a maximal 150cc volume, as defined by enhancing portion in contrast enhanced MRI
- Hemoglobin levels (Hb) equal or greater than 10ng/dl. Blood transfusions to correct the Hb will be allowed.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital das Clinicas da Faculdade de Medicina da USP Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.