The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)

Part of paid clinical trials in San Francisco, California.

Sponsor
Jasper Gerritsen
Study ID
NCT06146738
Status
Recruiting
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Conditions

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

Eligibility Criteria

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

Interventions

  • Palliative Care — BEHAVIORAL
    Best supportive care without surgical intervention
  • Tumor biopsy — PROCEDURE
    Tumor biopsy
  • Tumor resection — PROCEDURE
    Maximal safe resection of the tumor

Study Details

There is no consensus on the optimal treatment of patients with high-grade glioma, especially when patients have limited functioning performance at presentation (KPS ≤70). Therefore, there are varied practice patterns around pursuing biopsy, resection, or palliation (best supportive care). This study aims to characterize the impact of palliative care versus biopsy versus resection on survival and quality of life in these patients. Also, it will aim to determine if there is a subset of patients that benefit the most from resection or biopsy, for which outcome, and how they could be identified preoperatively. This study is an international, multicenter, prospective, 3-arm cohort study of observational nature. Consecutive HGG patients will be treated with palliative care, biopsy, or resection at a 1:3:3 ratio. Primary endpoints are: 1) overall survival, and 2) quality of life at 6 weeks, 3 months and 6 months after initial presentation based on the EQ-5D, EORTC QLQ C30 and EORTC BN 20 questionnaires. 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
1,015 participants (estimated)

Arms

  • Arm: Palliative Care
    Best supportive care without surgical intervention
  • Arm: Tumor biopsy
    Tumor biopsy
  • Arm: Tumor resection
    Maximal safe resection of the tumor

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
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By specialty
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By research site
University of California, San Francisco· San Francisco, CAMassachusetts General Hospital· Boston, MA

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