Preoperative brain irradiation for glioblastoma treatment
PreOperative Brain Irradiation in Glioblastoma
This study is testing if giving radiation treatment before surgery can help people with newly diagnosed glioblastoma have better outcomes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The Christie NHS Foundation Trust Academic / other |
| Drugs / interventions | radiation, chemotherapy |
| Locations | 1 site (Manchester, Greater Manchester) |
| Trial ID | NCT03582514 on ClinicalTrials.gov |
What this trial studies
This phase I study, known as PreOperative Brain Irradiation in Glioblastoma (POBIG), aims to evaluate the safety and feasibility of administering a single fraction of radiotherapy to patients newly diagnosed with glioblastoma before surgical intervention. The study seeks to address the issue of rapid early progression of the tumor by delivering radiotherapy prior to surgery, potentially improving patient outcomes. Participants will receive standard treatment following the radiotherapy, which includes tumor resection and postoperative chemotherapy and radiotherapy. The study will also determine the maximum tolerated dose of preoperative radiotherapy and the safe volume of tumor that can be irradiated.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a new radiological diagnosis of glioblastoma and an ECOG performance status of 0-1.
Not a fit: Patients with severe symptoms of raised intracranial pressure or those for whom surgery is not clinically appropriate may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could reduce the rate of rapid early progression in glioblastoma patients and improve overall survival rates.
How similar studies have performed: While the approach of preoperative radiotherapy is being explored, this specific study is novel and aims to fill a gap in current treatment protocols for glioblastoma.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years. * Male or female. * New radiological diagnosis of glioblastoma. * Performance status judged by World Health Organisation, Eastern Cooperative Oncology Group \[ECOG\] score = 0-1. * Case has been reviewed by Neuro-oncology multidisciplinary team (MDT - neurosurgeon, clinical oncologist, radiologist and pathologist); MDT consensus that offering study entry is clinically appropriate and safe i.e. patient unlikely to come to harm (e.g. hydrocephalus) from delayed surgery and pre-operative radiotherapy based on available clinical information and imaging. * Confirmation at first clinic visit that study entry is clinically appropriate and safe (e.g. lack of severe and debilitating symptoms of raised intracranial pressure). * Intention to treat with surgical resection and postoperative adjuvant therapy as per current standard of care (Stupp regimen). * Tumour size, location and configuration meet radiotherapy treatment planning criteria (e.g. to secure cold spot/hot spot, meets dose constraints for organs at risk when accounting for post-operative radiotherapy). * Adequate haematological and biochemical parameters for surgery and contrast agent administration (full blood count and coagulation profile deemed acceptable by clinical team, eGFR \>30ml/min). * Mental capacity to consent for treatment. * Able and willing to give informed consent. Exclusion Criteria: * Planned biopsy procedure only. * Suspicion of other tumour on CT body scan or known malignancy except non-melanoma skin cancer, completely resected cervical or prostate cancer (with Prostate Specific Antigen of less than or equal to 0.1 ng/ml) within the past 3 years. * Contraindications to contrast-enhanced MRI scanning (e.g. claustrophobia, gadolinium allergy).
Where this trial is running
Manchester, Greater Manchester
- The Christie NHS Foundation Trust — Manchester, Greater Manchester, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Gerben R Borst, MD, PhD — The Christie NHS Foundation Trust
- Study coordinator: Gerben R Borst, MD, PhD
- Email: gerben.borst@nhs.net
- Phone: 0161 446 3000
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.