Surgery for Recurrent Glioblastoma

• Register: ClinicalTrials.gov
• Last refreshed on: 2 August 2023
• Main ID: NCT02394626
• Date of registration: 11/03/2015
• Prospective Registration: Yes
• Primary sponsor: Insel Gruppe AG, University Hospital Bern
• Public title: Surgery for Recurrent Glioblastoma RESURGE
• Scientific title: RESURGE - Randomized Controlled Comparative Phase II Trial on Surgery for Glioblastoma Recurrence
• Date of first enrolment: May 1, 2015
• Target sample size: 120
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/ct2/show/NCT02394626
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Austria, Germany, Greece, Italy, Portugal, Romania, Switzerland

Contacts

• Name: Philippe Schucht, Prof. Dr. med.
• Affiliation: Dep. of Neurosurgery, Inselspital Bern

• Name: Luisa Neves da Silva

Key inclusion & exclusion criteria

Inclusion Criteria:

- Written informed consent

- =18 years of age

- Prior resection of glioblastoma confirmed by histology

- Glioblastoma pretreated with standard radiotherapy without or with temozolomide

- First progression according to RANO criteria

- First progression not within 3 months after completion of radiation therapy

- Complete removal of contrast-enhancing lesion considered feasible without significant
risk of permanent speech or motor function according to MRI as confirmed by study
eligibility committee after screening and prior to recruitment

- No encroachment of the M1 or A1 segments of the medial and anterior cerebral artery on
MRI

- No contrast enhancement in presumed speech and primary motor areas on MRI

- No midline shift on MRI

- No contrast enhancing ventricular spread, multifocal recurrence, meningeosis
carcinomatosa or infiltration of the contra-lateral hemisphere on MRI

- No contra-indication for surgery

- Good functional status (KPS = 70)

Exclusion Criteria



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Glioblastoma

Intervention(s)

Procedure: Surgery followed by adjuvant second-line therapy

Procedure: Second-line therapy alone

Primary Outcome(s)

Overall survival from the date of inclusion [Time Frame: From the date of inclusion until death/end of study, assessed up to 5.7 years]

Secondary Outcome(s)

Total number of days spent at home after recurrence [Time Frame: From the date of inclusion until death/end of study, assessed up to 5.7 years]

Progression-free survival [Time Frame: From the date of inclusion until the date of objective progression or the date of patient's death, whichever occurs first, assessed up to 5.7 years]

Recruitment rate for all screened patients [Time Frame: Screening and inclusion]

Total number of days spent outside home after recurrence [Time Frame: From the date of inclusion until death/end of study, assessed up to 5.7 years]

Morbidity of surgery [Time Frame: Every 3 months up to 2 years or until death, assessed up to 5.7 years]

Secondary ID(s)

368/14

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

European Organisation for Research and Treatment of Cancer - EORTC