The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Palliative Care, Tumor biopsy, Tumor resection.
- Who it may be relevant to
- Registry conditions: Glioblastoma, Glioblastoma Multiforme, Glioblastoma, IDH-wildtype, Glioblastoma Multiforme, Adult. Basic parameters: 18 years — 90 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Belgium, Germany, Netherlands, Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed 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.
Interventions
- Behavioral Palliative Care
Best supportive care without surgical intervention - Procedure Tumor biopsy
Tumor biopsy - Procedure Tumor resection
Maximal safe resection of the tumor
Primary outcome measures
- Overall survival [Time frame: Up to 5 years postoperatively]
- Quality of life at 3 months (EORTC QLQ C30) [Time frame: 3 months postoperatively]
- Quality of life at 3 months (EORTC QLQ BN20) [Time frame: 3 months postoperatively]
- Quality of life at 3 months (EQ-5D) [Time frame: 3 months postoperatively]
Secondary outcome measures (6)
- Quality of life at 6 weeks (EORTC QLQ C30) [Time frame: 6 weeks postoperatively]
- Quality of life at 6 weeks (EORTC QLQ BN20) [Time frame: 6 weeks postoperatively]
- Quality of life at 6 weeks (EQ-5D) [Time frame: 6 weeks postoperatively]
- Quality of life at 6 months (EORTC QLQ C30) [Time frame: 6 months postoperatively]
- Quality of life at 6 months (EORTC QLQ BN20) [Time frame: 6 months postoperatively]
- Quality of life at 6 months (EQ-5D) [Time frame: 6 months postoperatively]
Eligibility criteria
Inclusion criteria
- Age ≥18 years and ≤90 years
- Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon
- Written informed consent
Exclusion criteria
- Tumors of the cerebellum, brainstem or midline
- Inability to give written informed consent
- Secondary high-grade glioma due to malignant transformation from low-grade glioma
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- University of California, San Francisco — San Francisco
- Massachusetts General Hospital — Boston
Germany · 2 centers
- Technical University Munich — Munich
- University Hospital Heidelberg — Heidelberg
Netherlands · 2 centers
- Erasmus Medical Center — Rotterdam
- Haaglanden Medical Centre — The Hague
Belgium · 1 center
- University Hospital Leuven — Leuven
Switzerland · 1 center
- Inselspital Universitätsspital Bern — Bern
Identifiers
NCT: NCT06146738 · MEC-2020-0812-4