Clinical trial NCT06146738: The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)
Official title: The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Glioblastoma
Glioblastoma Multiforme
Glioblastoma, IDH-wildtype
Glioblastoma Multiforme, Adult
Keywords: Palliative care
Best supportive care
Biopsy
Resection
Quality of life
Survival
Glioblastoma
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Haaglanden Medical Centre
name: Universitaire Ziekenhuizen KU Leuven
name: University Hospital Heidelberg
name: Technical University of Munich
name: Insel Gruppe AG, University Hospital Bern
name: Massachusetts General Hospital
name: University of California, San Francisco
First posted: 2023-11-27
Enrollment: 1015
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

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.

Eligibility criteria: 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 outcomes:
measure: Overall survival
timeFrame: Up to 5 years postoperatively
measure: Quality of life at 3 months (EORTC QLQ C30)
timeFrame: 3 months postoperatively
measure: Quality of life at 3 months (EORTC QLQ BN20)
timeFrame: 3 months postoperatively
measure: Quality of life at 3 months (EQ-5D)
timeFrame: 3 months postoperatively
Secondary outcomes:
measure: Quality of life at 6 weeks (EORTC QLQ C30)
timeFrame: 6 weeks postoperatively
measure: Quality of life at 6 weeks (EORTC QLQ BN20)
timeFrame: 6 weeks postoperatively
measure: Quality of life at 6 weeks (EQ-5D)
timeFrame: 6 weeks postoperatively
measure: Quality of life at 6 months (EORTC QLQ C30)
timeFrame: 6 months postoperatively
measure: Quality of life at 6 months (EORTC QLQ BN20)
timeFrame: 6 months postoperatively
measure: Quality of life at 6 months (EQ-5D)
timeFrame: 6 months postoperatively
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Munich
country: Germany
facility: Technical University Munich
state: Bavaria
city: Heidelberg
country: Germany
facility: University Hospital Heidelberg
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid-Holland
city: The Hague
country: Netherlands
facility: Haaglanden Medical Centre
state: Zuid-Holland
city: Bern
country: Switzerland
facility: Inselspital Universitätsspital Bern
Study officials:
affiliation: Erasmus Medical Center
name: Jasper Gerritsen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: