Phase III Study Comparing 2 Brain Conformational Radiotherapy in Combination With Chemotherapy in the Treatment of Glioblastoma (SPECTRO GLIO)
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ClinicalTrials.gov Identifier: NCT01507506 |
Recruitment Status :
Terminated
First Posted : January 11, 2012
Last Update Posted : January 12, 2021
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Tracking Information | |||
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First Submitted Date ICMJE | December 20, 2011 | ||
First Posted Date ICMJE | January 11, 2012 | ||
Last Update Posted Date | January 12, 2021 | ||
Actual Study Start Date ICMJE | March 15, 2011 | ||
Actual Primary Completion Date | January 2, 2020 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
Overall survival defined as the time from randomization to the date of death or date of last follow-up news (censured data) [ Time Frame: 8 years ] | ||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Phase III Study Comparing 2 Brain Conformational Radiotherapy in Combination With Chemotherapy in the Treatment of Glioblastoma | ||
Official Title ICMJE | Phase III Randomized Study Comparing 2 Brain Conformational Radiotherapy in Combination With Chemotherapy in the Treatment of Glioblastoma : Standard 3D Conformational Radiotherapy Versus Intensity-modulated Radiotherapy With Simultaneous-integrated Boost Guided by Magnetic Resonance Spectroscopic Imaging | ||
Brief Summary | This is a multi-institutional phase III clinical study of interventional type. The trial will include 220 patients with confirmed unifocal glioblastoma over a period of 3 years + 3 years of follow up. Patients with unifocal glioblastoma (diagnosis confirmed by histology on tumoral biopsy or surgical specimen) and who meet all eligibility criteria will be randomized in one chemoradiotherapy arm :
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Detailed Description | Not Provided | ||
Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 3 | ||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Glioblastoma | ||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Terminated | ||
Actual Enrollment ICMJE |
180 | ||
Original Estimated Enrollment ICMJE |
220 | ||
Actual Study Completion Date ICMJE | January 2, 2020 | ||
Actual Primary Completion Date | January 2, 2020 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||
Accepts Healthy Volunteers ICMJE | No | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | France | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT01507506 | ||
Other Study ID Numbers ICMJE | 08 TETE 01 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Institut Claudius Regaud | ||
Study Sponsor ICMJE | Institut Claudius Regaud | ||
Collaborators ICMJE | Not Provided | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Institut Claudius Regaud | ||
Verification Date | January 2021 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |