Glioblastoma Cancer Glioblastoma
Conditions
Interventions
Stage 1 (IDEAL IIB study) of the trial is observational only and all participants will receive all technologies during surgery.
Stage 2 will be randomised. Randomisation will be via the web-based serv
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 05/04/2022: 1. Aged 18 - 70 years 2. Neuro-oncology Multi-Disciplinary Team (MDT) decision that the imaging shows a primary GB tumour which is maximally resectable (attempted gross total resection of all enhancing tumour) 3. Patient is suitable for concomitant 6 weeks adjuvant radiotherapy and temozolomide (TMZ) chemotherapy or adjuvant TMZ at the time of MDT decision 4. Able to receive 5-ALA 5. Willing and able to give informed consent 6. Able to complete trial questionnaires, this may be with support where English is not their first language (where compatible with the validation of questionnaires). (Stage 2 only) 7. Able to provide a proxy who is willing to complete questionnaires as requested (Stage 2 only) Previous inclusion criteria from 23/09/2021 to 05/04/2022: 1. Aged 18 - 70 years 2. Neuro-oncology Multi-Disciplinary Team (MDT) decision that the imaging shows a primary GB tumour which is maximally resectable (attempted gross total resection of all enhancing tumour) 3. Patient is suitable for concomitant 6 weeks adjuvant radiotherapy and temozolamide (TMZ) chemotherapy or adjuvant TMZ at the time of MDT decision 4. Willing and able to give informed consent 5. Able to understand written English to enable completion of trial questionnaires 6. Able to provide a proxy who is willing to complete questionnaires as requested Original inclusion criteria: 1. Aged 18 - 75 years 2. Neuro-oncology Multi-Disciplinary Team (MDT) decision that the imaging shows a primary GB tumour which is maximally resectable (attempted gross total resection of all enhancing tumour) 3. Patient is suitable for concomitant 6 weeks adjuvant radiotherapy and temozolamide (TMZ) chemotherapy or adjuvant TMZ at the time of MDT decision 4. Willing and able to give informed consent 5. Able to understand written English to enable completion of trial questionnaires 6. Able to provide a proxy who is willing to complete questionnaires as requested
Exclusion criteria
Exclusion criteria: 1. Midline/basal ganglia/cerebellum/brainstem GB 2. Multifocal GB 3. Recurrent GB 4. Suspected secondary GB 5. Contraindication to MRI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stage 1: Feasibility of using DTI and NiUS in addition to standard of care for neurosurgery assessed using: 1. Operation length measured using patient records, analysed post-operatively 2. Successful use of the technology measured using operating surgeon theatre reports completed during surgery and analysed post-operatively 3. Tumour resection shown by pre and post-op MRI scan 4. Surgical complications measured using number of return visits to theatre, and other medical complications and analysed at discharge Stage 2: Deterioration Free Survival (Global Health Status) measured using a composite measure obtained from the QLQ-C30 patient and proxy questionnaire at baseline, 5 days post-op/discharge, 6 weeks post-op, 3 month post-op, then every 3 months subsequently up to 24 months post-op, Progression-Free Survival (PFS) and Overall Survival (OS) measured using patient records Updated 05/04/2022: Deterioration Free Survival (Global Health Status) measured using a composite measure obtained from the QLQ-C30 patient and proxy questionnaire at baseline, 6 weeks post-op, 3 months post-op, then every 3 months subsequently up to 24 months post-op, Progression-Free Survival (PFS) and Overall Survival (OS) measured using patient records | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 19/08/2022: Secondary Outcomes (In Stage 2 only) 1. To assess whether additional intraoperative imaging (DTI and iUS*) to standard of care (Neuronavigation and intraoperative 5-ALA) improves DFS where deterioration relates to physical functioning, social functioning from the QLQ-C30, and motor dysfunction and communication deficit. Measured using 4 composites using the respective domain of QLQ-C30 (physical functioning and social functioning) and BN20 (motor dysfunction and communication deficit) combined with PFS and OS. To be recorded at baseline; 6wks post-op., 3mths post-op., and then 3mthly up to 24 months 2. To assess whether additional intraoperative imaging (DTI and iUS*) to standard of care (Neuronavigation and intraoperative 5-ALA) improves time to deterioration. Measured similarly to DFS with the exception that progression is excluded as an event (i.e. only deterioration or death are considered). There will be five time to deterioration outcomes, one for each of the domains utilised in the primary and secondary DFS outcomes, used in turn to define deterioration. To be recorded at 6wks post-op., 3mths post-op., and then 3mthly up to 24 months 3. To assess whether additional intraoperative imaging (DTI and IUS*) to standard of care (Neuronavigation and intraoperative 5-ALA) improves Overall Survival (OS). Measured by OS (time from randomisation to death or trial closure). To be recorded at 24 months 4. To assess whether additional intraoperative imaging (DTI and iUS*) to standard of care (Neuronavigation and intraoperative 5-ALA) improves Progression Free Survival (PFS). Measured by PFS (time from randomisation to radiological tumour progression on imaging, as agreed in local MDT). To be recorded from MRI at 6 months post-op., and then 3mthly up to 24 months 5. To assess whether additional intraoperative imaging (DTI and iUS*) to standard of care (Neuronavigation and intraoperative 5-ALA) improves the extent of tum | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactMelody Chin
Outcome results
None listed