Repeat surgery for patients with recurrent glioblastoma Cancer
Conditions
Interventions
This is a two-arm, pragmatic randomised controlled trial in adults with recurrent glioblastoma (GB). Participants will be followed for a maximum of 12 months from randomisation.
Intervention arm: Re
Sponsors
University of Oxford
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or above 2. First recurrence/progression of IDH wild-type GB following previous maximal safe resection (attempted gross total resection of contrast-enhancing tumour) as confirmed by local Neuro-oncology Multidisciplinary Team (MDT) 3. WHO Performance Status 0-2 4. Neuro-oncology MDT feels that the patient should be offered the trial and confirms that repeat maximal safe resection (>90%) is feasible and a reasonable treatment option 5. Able to give informed consent 6. Able to provide a proxy who is willing to complete the trial questionnaires
Exclusion criteria
Exclusion criteria: 1. Recurrence/progression of GB within 6 weeks of completion of radiotherapy (6 weeks or short course), with or without concomitant chemotherapy (See note* below) 2. Multifocal recurrence/progression of GB 3. Contraindication to MRI 4. Glioblastoma located in the brainstem, basal ganglia or the thalamus *In the UK, standard treatment for operable glioblastoma consists of surgery followed by radiotherapy (with or without concomitant chemotherapy), then a short treatment break before starting adjuvant chemotherapy. The exclusion criterion refers to recurrence or progression occurring within 6 weeks of completing radiotherapy. Patients are therefore only eligible for RECURRENT GB once they have completed radiotherapy and reached the point at which adjuvant chemotherapy would normally begin, or are further along in their treatment pathway.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Deterioration-free survival (DFS): Time from randomisation to either a =10-point deterioration from baseline in Global Health Status (GHS) without subsequent recovery, or death measured using Q29 & Q30 of EORTC QLQ-C30 questionnaire and mortality data from hospital records/NHS Spine at baseline, then weekly up to 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS): Time from randomisation to death, up to 12 months measured using hospital records/NHS Spine at one time point for data collection at the end of the study;Progression-free survival (PFS): Time to radiological tumour progression or death (MRI/MDT), up to 12 months measured using hospital records/NHS Spine at one time point for data collection at the end of the study;Health-related quality of life (HRQoL) measured using the EORTC QLQ-C30 and QLQ-BN20 at baseline and 6-weekly;Physical/social functioning, motor and communication deficits measured using domains of QLQ-C30/BN20 at baseline and 6-weekly;Performance status and Activities of Daily Living (ADLs) measured using WHO ECOG + QLQ-C30 items at baseline and 6-weekly;Seizure frequency and neurocognitive/physical symptoms measured using QLQ-C30/BN20 at baseline and 6-weekly;Surgical complications: Incidence/type within 31 days post-op (intervention arm) measured using hospital records/NHS Spine at one time point;Completion of adjuvant therapy: Proportion starting/completing therapy, up to 12 months measured using hospital records/NHS Spine at one time point;Extent of resection: Residual tumour volume on MRI within 72 hours post-op (intervention arm) measured using hospital records/NHS Spine at one time point;Health economics measured using QALYs via EQ-5D-5L, resource use from hospital records at baseline and 3-monthly; incremental cost per QALY modelled over lifetime;Carer QoL measured using EQ-5D-5L (proxy) at baseline and 6-monthly | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactMelody Chin
Outcome results
None listed