IWOT (EORTC 1635-BTG)
Research type
Research Study
Full title
IDH mutated 1p/19q intact lower grade glioma following resection: Wait Or Treat? IWOT – A phase III study
IRAS ID
276313
Contact name
Sara Erridge
Contact email
Sponsor organisation
European Organisation for Research and Treatment of Cancer
Eudract number
2018-003539-31
Clinicaltrials.gov Identifier
Duration of Study in the UK
12 years, 1 months, 1 days
Research summary
Summary of Research
This phase III study is for adults who have a type of brain tumour called low grade glioma or IDHmt astrocyctoma who have had surgery to remove the tumour. Recent studies have suggested that use of radiotherapy and chemotherapy maybe beneficial for some patients with grade II and III glioma but these treatments have potential long term side effects, for example on cognition. Low grade glioma with IDH mutation have a favorable prognosis so there is a question as to whether or not this group of patients are best treated immediately after surgery with brain radiation therapy and chemotherapy after their surgery, or than waiting to start treatment when the tumour starts to grow (‘active surveillance’).
This is determined by looking at the length of time between participants joining the study and the start of further treatment (i.e. second treatment after early treatment or second treatment after active surveillance) or death, whichever
occurs first.
This study not only looks at length of survival but also cognition and quality of life to help inform clinicians and patients as to the best management strategy for their tumour.This study will take place in NHS sites in the UK as part of a wider international study. The study is sponsored and coordinated by the EORTC (European Organisation for Research and Treatment of Cancer), a non-profit organisation based in Brussels.
Summary of Results
The study was closed for poor accrual and therefore analyses described in the protocol could not be performed. Instead in this short report, a descriptive overview of randomized patients, response, efficacy, and AEs numbers available is presented. At the database lock date 25/01/2022, 18 patients out of the planned 624 were randomized, 9 to standard arm (active surveillance arm) and 9 to investigational arm (early treatment arm). Overall response: 1 partial response was observed in early treatment arm. No progressions or death were reported. However, follow-up for the patients in this study was very limited due to closure for poor accrual.
Safety Results: Reported grade 4 Adverse Events (AEs): Neutropenia (1 AE , 1 patient in early treatment arm) Reported grade 3 AEs: Seizure (2 AEs , 1 patient in early treatment arm)
Conclusions: At time of study closure, efficacy and safety data reported in EORTC database were very limited.REC name
South Central - Berkshire Research Ethics Committee
REC reference
20/SC/0118
Date of REC Opinion
23 Mar 2020
REC opinion
Favourable Opinion