Evaluating the impact of repeat surgery on recurrent Glioblastoma
Role of Repeat Resection in Recurrent Glioblastoma (4rGBM) Trial: a Randomized Care Trial for Patients with Recurrent GBM
This study tests if having another surgery can help people with recurrent Glioblastoma live longer and spend more time at home instead of in the hospital.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Alberta Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Edmonton, Alberta) |
| Trial ID | NCT04838782 on ClinicalTrials.gov |
What this trial studies
This study investigates the role of repeat surgical resection in patients with recurrent Glioblastoma (GBM), aiming to provide a structured approach for neurosurgeons in managing these cases. It seeks to determine whether repeat surgery can improve median overall survival and increase the number of days patients spend outside of hospital or palliative care settings. The study does not introduce additional risks or interventions beyond standard care, focusing on observational outcomes to address the lack of Level 1 evidence in this area.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who have previously undergone surgical resection for Glioblastoma and are considered by their surgeon to potentially benefit from repeat surgery.
Not a fit: Patients who are unable to provide informed consent or those who have not had a prior surgical resection of their Glioblastoma will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence that repeat surgical resection improves survival and quality of life for patients with recurrent Glioblastoma.
How similar studies have performed: While observational studies suggest potential benefits of repeat surgery for recurrent GBM, this study aims to provide more structured evidence, making it a novel approach in this context.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 * Previously histologically confirmed and surgically resected Glioblastoma * Previous craniotomy for open tumor resection (needle biopsies alone do not count as resection) * The attending surgeon considers re-operation may improve quality survival Exclusion Criteria: * Informed consent not possible
Where this trial is running
Edmonton, Alberta
- University of Alberta Division of Neurosurgery — Edmonton, Alberta, Canada (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.