Survival of patients with recurrent malignant brain tumor (glioblastoma multiforme) treated with surgical resection and local chemotherapy using impregnated wafer (Gliadel® ) in relation to a clinical predictor; the methylation of methylguanin-DNA-methyltransferase (MGMT) promotor

Survival of patients with recurrent glioblastoma multiforme treated with local carmustine wafer (Gliadel® ) in relation to the methylation of methylguanin-DNA-methyltransferase (MGMT) promotor

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ISRCTN

Registry ID

ISRCTN15192099

Enrollment

Registered

2016-04-06

Start date

2015-10-01

Completion date

Unknown

Last updated

2022-08-29

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

Conditions

Recurrent glioblastoma multiforme WHO IV, primary treated by surgical resection and radiochemotherapy. Cancer Glioblastoma Multiforme

Interventions

Male and female subjects =18 years with the first recurrent manifestation of a malignant glioma that have undergone min. one cycle of the Stupp scheme after surgical treatment of the initial manifesta

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. First recurrent manifestation of a glioblastoma multiforme 2. Female and male =18 years 3. Previous adjuvant radio-chemotherapy chemotherapy in accordance with the ”Stupp protocol" 4. The indication for revision surgery follows the usual balancing of risks and benefits of the therapy, informed consent and –finally- decision of the patient

Exclusion criteria

Exclusion criteria: 1. Patients who underwent more than one surgical revision of malignant glioma 2. Previous implantation of carmustine wafer (Giadel ®) 3. More than six cycles of the Stupp scheme (radio-chemotherapy)

Design outcomes

Primary

Measure	Time frame
Overall survival (measured by the date of resection and carmustine wafer implantation and time of death) in relation to the methylation of the MGMT promoter	—

Secondary

Measure	Time frame
1. Progression free survival after first revision surgery measured by the recurrence criteria (MacDonald) in cerebral CT and MRI scans in follow-up visits at 3, 6 and 12 months 2. Quality of Life (generic: Short-Form [SF] 36) at one year of follow-up 3. Complication rates (edema, infections, bleeding, surgical revisions for all causes, serious adverse events [SAE]) throughout the study	—

Countries

Germany

Contacts

Public ContactPawel Gutowski

Pawel.Gutowski@ukb.de+49 030/5681-3724

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026