PreOperative Brain Irradiation in Glioblastoma (POBIG)
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|ClinicalTrials.gov Identifier: NCT03582514|
Recruitment Status : Recruiting
First Posted : July 11, 2018
Last Update Posted : August 4, 2022
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|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Multiforme||Radiation: Preoperative brain irradiation (single fraction)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||18 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||The study uses a Continual Reassessment Method (CRM) to inform dose escalation and determine the MTD and MTIV. This is a Bayesian statistics-based model. It uses all available data from previous doses to guide dose escalation.|
|Masking:||None (Open Label)|
|Official Title:||PreOperative Brain Irradiation in Glioblastoma|
|Actual Study Start Date :||April 19, 2022|
|Estimated Primary Completion Date :||February 28, 2024|
|Estimated Study Completion Date :||February 28, 2024|
Experimental: Dose or volume radiation escalation
Patients with a new radiological diagnosis of GBM (judged by the neuro-oncology multidisciplinary team) are to be considered for this study.
This study arm will use 5 radiotherapy doses (6 Gy, 8 Gy, 10 Gy, 12 Gy and 14 Gy) and three treatment volumes (<30 cm3, 30-60 cm3 and >60 cm3). The study will use 6 dosing levels based on a combination of radiotherapy dose and treatment volume. The stepwise inclusion process allows for variation in tumour volume and location. The study will commence with dosing level 1: 8 Gy to <30 cm3 and 6 Gy to 30-60 cm3. In collaboration with the Clinical Trials Unit, the Trial Management Group will enter outcome data for patients at a given dose level into the CRM model. The model output will then guide dose escalation to determine the next dose level. After the single fraction of radiotherapy, patients will receive the standard treatment.
Radiation: Preoperative brain irradiation (single fraction)
Dose and volume escalation of preoperative single-fraction radiotherapy.
- Maximum tolerated dose (MTD) and maximum tolerated irradiation volume (MTIV) of single-fraction preoperative radiotherapy in patients with a new radiological diagnosis of glioblastoma [ Time Frame: 18 months ]
These will be determined by the following dose limiting complications:
- Radiotherapy related swelling leading to a change of the scheduled date of surgery.
- Post-operative radiotherapy commencement delayed to beyond 6 weeks after surgery due to radiation related symptoms and/or complications from surgery.
- Interruption of post-operative radiotherapy >5 days.
- Registration of postoperative surgical complications. [ Time Frame: 18 months ]
- Radiotherapy related complications [ Time Frame: 18 months ]
- Progression free survival. [ Time Frame: 18 months ]
- Overall survival. [ Time Frame: 18 months ]
- Steroid dose after preoperative radiotherapy. [ Time Frame: 18 months ]
- The tumor volume differences measured between the post-surgery MRI and pre-radiotherapy MRI [ Time Frame: 18 months ]To confirm usability of the MRI to select GBM patients for preoperative single fraction radiotherapy.
- Concordance between MRI based diagnosis of glioblastoma and definitive histological diagnosis. [ Time Frame: 18 months ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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.
- 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03582514
|Contact: Gerben R Borst, MD, PhD||0161 446 firstname.lastname@example.org|
|The Christie NHS Foundation Trust||Recruiting|
|Manchester, Greater Manchester, United Kingdom, M20 4BX|
|Contact: Gerben R Borst, MD,PhD|
|Principal Investigator:||Gerben R Borst, MD, PhD||The Christie NHS Foundation Trust|
|Responsible Party:||The Christie NHS Foundation Trust|
|Other Study ID Numbers:||
21/NW/0121 ( Other Identifier: GM South Research Ethics Committee )
|First Posted:||July 11, 2018 Key Record Dates|
|Last Update Posted:||August 4, 2022|
|Last Verified:||August 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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