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Dose and Volume Escalation of Preoperative Brain Irradiation in GBM Patients - the POBIG trial

Dose and Volume Escalation of Preoperative Brain Irradiation in GBM Patients - the POBIG trial - POBIG

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON46343
Enrollment
60
Registered
2018-06-04
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

brain tumour Glioblastoma

Interventions

Single fraction preoperative radiotherapy.

Sponsors

Antoni van Leeuwenhoek Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * 18 years or older * Newly diagnosed GBM (based on MRI imaging or biopsy) * Ability to undergo standard treatment consisting of (chemo)radiation and surgery (i.e. KPS > 70, indication that more than 70% of the tumor can be removed) * Neuro-oncology multidisciplinary team consensus to include the patient for the current study * Signed written informed consent

Exclusion criteria

Exclusion criteria: * Prior or second invasive malignancy, except non-melanoma skin cancer, completely resected cervical or prostate cancer (with PSA of less than or equal to 0.1 ng/ml) * Suspicion of primary tumor on CT thorax/abdomen in case no biopsy is available * Inability to secure a *coldspot* in the tumor (volume of 2 cc of the contrast enhancing tumor that should not receive irradiation dose, see Chapter 2 and 4) * Inability to secure radiotherapy dose constraints for organs at risk for either the neoadjuvant stereotactic radiosurgery or adjuvant fractionated radiotherapy (see Chapter 2 and 4)

Design outcomes

Primary

MeasureTime frame
* maximum tolerated dose (MTD) * maximum tolerated irradiated volume (MTIV)

Secondary

MeasureTime frame
* Registration of postoperative surgical complications. * Progression free survival. * Overall survival.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)