Trials / Terminated
TerminatedNCT03763422
Trial in Low Grade Glioma Patients: Wait or Treat
IDH Mutated 1p/19q Intact Lower Grade Glioma Following Resection: Wait Or Treat? IWOT - a Phase III Study
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 19 (actual)
- Sponsor
- European Organisation for Research and Treatment of Cancer - EORTC · Network
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The 1635-EORTC-BTG study - Wait or Treat - concerns patients that represent a clinically favorable group of patients with IDHmutated astrocytoma (oligo-symptomatic), without a need for immediate post-operative treatment. It will establish whether early adjuvant treatment with radiotherapy and adjuvant temozolomide in resected IDHmutated astrocytoma will improve outcome, and whether benefits of early treatment outweigh potential side-effects of that, such as deterioration in neurocognitive function or Quality of Live, seizure activity and Patient Reported outcome compared to active surveillance.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Temozolomide | Oral Administration of Temozolomide |
| RADIATION | Radiotherapy | 50.4 Gy in 28 fractions over 6 weeks |
| PROCEDURE | Surgery | Surgery |
Timeline
- Start date
- 2020-03-16
- Primary completion
- 2021-12-29
- Completion
- 2021-12-29
- First posted
- 2018-12-04
- Last updated
- 2022-02-01
Locations
45 sites across 10 countries: Australia, Austria, Belgium, Denmark, France, Italy, Netherlands, Spain, Switzerland, United Kingdom
Source: ClinicalTrials.gov record NCT03763422. Inclusion in this directory is not an endorsement.