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

NCT06146738 · tracked via the Priya Life Science Germany tracker

Sponsor

Jasper Gerritsen

Phase

Observational

Started

2023-01-01

Last updated

2023-11-27

Condition(s) studied

GlioblastomaGlioblastoma MultiformeGlioblastoma, IDH-wildtypeGlioblastoma Multiforme, Adult

Investigational drug(s) / intervention(s)

Palliative CareTumor biopsyTumor resection

Palliative Care: Best supportive care without surgical intervention

Tumor biopsy: Tumor biopsy

Tumor resection: Maximal safe resection of the tumor

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

Sex

ALL

Min age

18 Years

Max age

90 Years

Healthy volunteers

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 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 adequately treated in situ carcinoma of any organ or basal cell carcinoma of the skin

Primary outcome measure(s)

Overall survival — Up to 5 years postoperatively
Time from diagnosis to death from any cause
Quality of life at 3 months (EORTC QLQ C30) — 3 months postoperatively
Quality of life as assessed by the EORTC QLQ C30 questionnaire
Quality of life at 3 months (EORTC QLQ BN20) — 3 months postoperatively
Quality of life as assessed by the EORTC QLQ BN20 questionnaire
Quality of life at 3 months (EQ-5D) — 3 months postoperatively
Quality of life as assessed by the EQ-5D questionnaire

Trial sites (8)

Facility	City	Region	Status
University of California, San Francisco	San Francisco	California	Recruiting
Massachusetts General Hospital	Boston	Massachusetts	Recruiting
University Hospital Leuven	Leuven	Belgium	Recruiting
Technical University Munich	Munich	Bavaria	Not Yet Recruiting
University Hospital Heidelberg	Heidelberg	Germany	Recruiting
Erasmus Medical Center	Rotterdam	South Holland	Recruiting
Haaglanden Medical Centre	The Hague	South Holland	Recruiting
Inselspital Universitätsspital Bern	Bern	Switzerland	Not Yet Recruiting

More Jasper Gerritsen trials in Germany

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

The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201) Recruiting

The RECSUR-study: Resection Versus Best Oncological Treatment for Recurrent Glioblastoma (ENCRAM 2302) Recruiting

Other trials for the same condition

Study of Ribociclib and Everolimus in HGG and DIPG or Ribociclib and Temozolomide in DHG, H3G34-mutant Recruiting

Sonocloud-9 in Association With Carboplatin Versus Standard-of-Care Chemotherapies (CCNU or TMZ) in Recurrent GBM Recruiting

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

The SUPRAMAX Study: Supramaximal Resection Versus Maximal Resection for High-Grade Glioma Patients (ENCRAM 2201) Recruiting

A Study Comparing Niraparib With Temozolomide in Adult Participants With Newly-diagnosed, MGMT Unmethylated Glioblastoma Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06146738 on ClinicalTrials.gov ↗ ← All trials in Germany