The RESBIOP-study: Resection Versus Biopsy in High-grade Glioma Patients (ENCRAM 2202)

Part of paid clinical trials in San Francisco, California.

Sponsor
Jasper Gerritsen
Study ID
NCT06146725
Status
Recruiting
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Conditions

  • Glioblastoma
  • Glioblastoma Multiforme
  • Glioblastoma Multiforme of Brain
  • Glioblastoma Multiforme, Adult
  • Glioblastoma, IDH-wildtype

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Tumor resection — PROCEDURE
    Maximal safe resection of the tumor
  • Tumor biopsy — PROCEDURE
    Biopsy of the tumor

Study Details

There are no guidelines or prospective studies defining the optimal surgical treatment for gliomas of older patients (≥70 years) or those with limited functioning performance at presentation (KPS ≤70). Therefore, the decision between resection and biopsy is varied, amongst neurosurgeons internationally and at times even within an instiutition. This study aims to compare the effects of maximal tumor resection versus tissue biopsy on survival, functional, neurological, and quality of life outcomes in these patient subgroups. Furthermore, it evaluates which modality would maximize the potential to undergo adjuvant treatment. This study is an international, multicenter, prospective, 2-arm cohort study of observational nature. Consecutive HGG patients will be treated with resection or biopsy at a 3:1 ratio. Primary endpoints are: 1) overall survival (OS) and 2) proportion of patients that have received adjuvant treatment with chemotherapy and radiotherapy. Secondary endpoints are 1) proportion of patients with NIHSS (National Institute of Health Stroke Scale) deterioration at 6 weeks, 3 months and 6 months after surgery 2) progression-free survival (PFS); 3) quality of life at 6 weeks, 3 months and 6 months after surgery and 4) frequency and severity of Serious Adverse Events (SAEs). Total duration of the study is 5 years. Patient inclusion is 4 years, follow-up is 1 year.

Key Dates

Start date
Jan 1, 2023
Status verified
Nov 2023
Primary completion
Jan 1, 2028
Completion
Jan 1, 2029

Study Design

Enrollment
564 participants (estimated)

Arms

  • Arm: Tumor resection
    Tumor resection
  • Arm: Tumor biopsy
    Tumor biopsy

Primary Outcome Measure

Overall survival [ Time Frame: Up to 5 years postoperatively ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, San FranciscoSan FranciscoCalifornia94143
Mitchel Berger, MD PhD
Massachusetts General HospitalBostonMassachusetts02114
Brian Nahed, MD

Find similar trials in San Francisco, CA

By condition
Brain cancer
By specialty
OncologyNeuro-oncology
By research site
University of California, San Francisco· San Francisco, CAMassachusetts General Hospital· Boston, MA

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