RESURGE - Randomized Controlled Comparative Phase II Trial on Surgery for Glioblastoma Recurrence
Indication :

Gliobastome récidivant


Sponsor :

University Hospital Inselspital, Berne


Phase :

II


Ligne :

2


Traitement :

Surgery followed by adjuvant second-line therapy


Site :

CHUV


Contact(s) :
Dr Andreas Hottinger
Investigateur principal

CHUV
Oncologie

Rue de Bugnon 46
Lausanne
1011

021 314 65 41
andreas.hottinger@chuv.ch

Primary objective :

The primary objective of this randomized trial is to compare survival outcome after surgery followed by adjuvant second-line therapy to no surgery followed by second-line therapy in recurrent glioblastoma. An auxiliary objective to primary objective is to compare the survival outcomes of operated patients to control in the subgroups stratified by extent of resection: incomplete resection vs complete resection.


Inclusion criteria :
  1. Written informed consent
  2. ≥18 years of age
  3. Prior resection of glioblastoma confirmed by histology
  4. Glioblastoma pretreated with standard radiotherapy without or with temozolomide
  5. First progression according to RANO criteria
  6. First progression not within 3 months after completion of radiation therapy
  7. 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
  8. No encroachment of the M1 or A1 segments of the medial and anterior cerebral artery on MRI
  9. No contrast enhancement in presumed speech and primary motor areas on MRI
  10. No midline shift on MRI
  11. No contrast enhancing ventricular spread, multifocal recurrence, meningeosis carcinomatosa or infiltration of the contra-lateral hemisphere on MRI
  12. No contra-indication for surgery
  13. Good functional status (KPS ≥ 70)

Exclusion criteria :

None