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

Last updated: November 18, 2023
Sponsor: Jasper Gerritsen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Glioblastoma Multiforme

Gliomas

Astrocytoma

Treatment

Tumor resection

Tumor biopsy

Palliative Care

Clinical Study ID

NCT06146738
MEC-2020-0812-4
  • Ages 18-90
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age ≥18 years and ≤90 years
  2. Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon
  3. Written informed consent

Exclusion

Exclusion Criteria:

  1. Tumors of the cerebellum, brainstem or midline
  2. Inability to give written informed consent
  3. Secondary high-grade glioma due to malignant transformation from low-grade glioma
  4. Second primary malignancy within the past 5 years with the exception of adequatelytreated in situ carcinoma of any organ or basal cell carcinoma of the skin

Study Design

Total Participants: 1015
Treatment Group(s): 3
Primary Treatment: Tumor resection
Phase:
Study Start date:
January 01, 2023
Estimated Completion Date:
January 01, 2029

Study Description

Trial design This is an international, multicenter, prospective, observational, 3-arm cohort study (registration: clinicaltrials.gov ID number TBA). Eligible patients are treated with either palliative care, biopsy, or resection with a 1:3:3 ratio with a sequential computer-generated random number as subject ID.

Study objectives The primary study objective is to evaluate safety and efficacy of palliative care versus surgery in HGG patients as measured by overall survival (OS) and quality of life questionnaires (QLQ C30, EORTC QLQ BN20, EQ 5D).

The primary outcomes are 1) overall survival (OS) defined as time from diagnosis to death from any cause; 2) proportion of patients with health-related quality of life deterioration of 10 points or more in the EORTC QLQ C30 questionnaire or EORTC QLQ BN20 questionnaire at 3 months after outpatient clinic visit.

Study setting and participants Patients will be recruited from the neurosurgical or neurological outpatient clinic or through referral from general hospitals of the participating neurosurgical hospitals, located in Europe and the United States. The study is carried out by centers from the ENCRAM Consortium.

Study patients are allocated to either the supramaximal or maximum safe resection group and will undergo evaluation at presentation (baseline) and during the follow-up period at 6 weeks, 3 months, and 6 months. Patient functioning with be assessed with the Karnofsky Performance Scale (KPS) and the ASA (American Society of Anesthesiologists) physical status classification system. Health-related quality of life (HRQoL) will be assessed with the EORTC QLQ C30, EORTC QLQ BN20 and EQ 5D questionnaires. Overall survival will be assessed at 6 months postoperatively. We expect to complete patient inclusion in 4 years. The estimated duration of the study (including follow-up) will be 5 years.

Connect with a study center

  • University Hospital Leuven

    Leuven,
    Belgium

    Active - Recruiting

  • Technical University Munich

    Munich, Bavaria 74076
    Germany

    Site Not Available

  • University Hospital Heidelberg

    Heidelberg,
    Germany

    Active - Recruiting

  • Erasmus Medical Center

    Rotterdam, Zuid-Holland 3015 GD
    Netherlands

    Active - Recruiting

  • Haaglanden Medical Centre

    The Hague, Zuid-Holland 2512 VA
    Netherlands

    Active - Recruiting

  • Inselspital Universitätsspital Bern

    Bern, 3010
    Switzerland

    Site Not Available

  • University of California, San Francisco

    San Francisco, California 94143
    United States

    Active - Recruiting

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

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