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Trial in Low Grade Glioma Patients: Wait or Treat

NCT03763422 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2022-02-01

No results posted yet for this study

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

DRUG

Temozolomide

Oral Administration of Temozolomide

RADIATION

Radiotherapy

50.4 Gy in 28 fractions over 6 weeks

PROCEDURE

Surgery

Surgery

Sponsors & Collaborators

  • Cooperative Trials Group for Neuro-Oncology (COGNO)

    collaborator UNKNOWN

  • European Organisation for Research and Treatment of Cancer - EORTC

    lead NETWORK

Principal Investigators

  • Martin Van den Bent · EORTC Study Coordinator

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-16
Primary Completion
2021-12-29
Completion
2021-12-29

Countries

  • Australia
  • Austria
  • Belgium
  • Denmark
  • France
  • Italy
  • Netherlands
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03763422 on ClinicalTrials.gov