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Early Treatment arm for Temozolomide (IWOT Trial)
Phase 3
Waitlist Available
Led By Martin Van den Bent
Research Sponsored by European Organisation for Research and Treatment of Cancer - EORTC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up the iwot seizure control composite score index can be completed up to 4 weeks before or after the planned assessment. a time window of 8 weeks is therefore available for each assessment. assessed up to 11.5 years after fpi
Awards & highlights
Pivotal Trial
No Placebo-Only Group
Summary
This trial will test whether early treatment can help patients with IDH-mutated astrocytomas, and if it's worth the possible side-effects.
Eligible Conditions
- Temozolomide
- Brain Tumor
- Clinical Trials
- Watchful Waiting
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ the iwot seizure control composite score index can be completed up to 4 weeks before or after the planned assessment. a time window of 8 weeks is therefore available for each assessment. assessed up to 11.5 years after fpi
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~the iwot seizure control composite score index can be completed up to 4 weeks before or after the planned assessment. a time window of 8 weeks is therefore available for each assessment. assessed up to 11.5 years after fpi
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
HRQoL related to seizures
Safety profile: CTCAE
Seizure activity
+1 moreAwards & Highlights
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Early Treatment armExperimental Treatment2 Interventions
Radiotherapy + Temozolomide
Group II: Active surveillance armActive Control3 Interventions
Treatment as per local practice
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Temozolomide
2010
Completed Phase 3
~1880
Radiotherapy
2017
Completed Phase 3
~2610
Find a Location
Who is running the clinical trial?
European Organisation for Research and Treatment of Cancer - EORTCLead Sponsor
414 Previous Clinical Trials
165,662 Total Patients Enrolled
Cooperative Trials Group for Neuro-Oncology (COGNO)UNKNOWN
Martin Van den BentPrincipal InvestigatorEORTC Study Coordinator
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