Hypofractionated Radiation Therapy for Glioblastoma
1 other identifier
interventional
58
1 country
1
Brief Summary
Notwithstanding major improvements in treatment modalities, the prognosis of patients with glioblastoma is poor. Hypofractionated radiation therapy as an alternative of the standard 6-week regimen could be an attractive approach as an effort to prevent tumor cell repopulation and reduction the total treatment period promoting patient comfort and convenience.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jun 2017
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 5, 2017
CompletedFirst Submitted
Initial submission to the registry
July 5, 2017
CompletedFirst Posted
Study publicly available on registry
July 11, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedJuly 11, 2017
July 1, 2017
2 years
July 5, 2017
July 7, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Overall survival
From date of the start of treatment to date of death due to any cause.
24 months
Secondary Outcomes (1)
Progression-free survival
24 months
Study Arms (1)
Hypofractionated radiation therapy
EXPERIMENTALHypofractionated radiation therapy Total dose: 60 Gy (20 fractions / 3 Gy per fraction) with concurrent temozolomide 75 mg/m2 given 7 days/week. After a 30-days break, adjuvant temozolomide days 1-5 every 28 days for 6 cycles.
Interventions
Hypofractionated radiation therapy Total dose: 60 Gy (20 fractions / 3 Gy per fraction)
Eligibility Criteria
You may qualify if:
- Patients 18 to 70 years of age with newly diagnosed and histologically confirmed glioblastoma.
- WHO performance status of 2 or less and adequate hematologic, renal, and hepatic function.
You may not qualify if:
- Prior diagnosis of cancer, unless disease free for \> 3 years
- Previous history of radiotherapy in the head and neck region (except initial larynx tumor - T1, T2 / N0M0).
- Specific severe, active co-morbidities
- Tumor located in the brainstem
- Presence of leptomeningeal carcinomatosis
- Multicentric tumor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Instituto do Cancer do Estado de São Paulo (ICESP) - FMUSP
São Paulo, São Paulo, 01246-000, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Radiation Oncologist and Principal Investigator
Study Record Dates
First Submitted
July 5, 2017
First Posted
July 11, 2017
Study Start
June 5, 2017
Primary Completion
June 1, 2019
Study Completion
June 1, 2020
Last Updated
July 11, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share