RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-01-01
Study Completion:2029-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06146738

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Not specified
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥18 years and ≤90 years
  2. 2. Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon
  3. 3. Written informed consent
  1. 1. Tumors of the cerebellum, brainstem or midline
  2. 2. Inability to give written informed consent
  3. 3. Secondary high-grade glioma due to malignant transformation from low-grade glioma
  4. 4. Second primary malignancy within the past 5 years with the exception of adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin

Contacts and Locations

Study Contact

Jasper Gerritsen, MD PhD
CONTACT
31107036130
j.gerritsen@erasmusmc.nl
Arnaud Vincent, MD PhD
CONTACT
31107034211
a.vincent@erasmusmc.nl

Principal Investigator

Jasper Gerritsen, MD PhD
PRINCIPAL_INVESTIGATOR
Erasmus Medical Center

Study Locations (Sites)

University of California, San Francisco
San Francisco, California, 94143
United States
Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Jasper Gerritsen

  • Jasper Gerritsen, MD PhD, PRINCIPAL_INVESTIGATOR, Erasmus Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-01-01
Study Completion Date2029-01-01

Study Record Updates

Study Start Date2023-01-01
Study Completion Date2029-01-01

Terms related to this study

Keywords Provided by Researchers

  • Palliative care
  • Best supportive care
  • Biopsy
  • Resection
  • Quality of life
  • Survival
  • Glioblastoma

Additional Relevant MeSH Terms

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