Trial Title:
The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)
NCT ID:
NCT06146738
Condition:
Glioblastoma
Glioblastoma Multiforme
Glioblastoma, IDH-wildtype
Glioblastoma Multiforme, Adult
Conditions: Official terms:
Glioblastoma
Conditions: Keywords:
Palliative care
Best supportive care
Biopsy
Resection
Quality of life
Survival
Glioblastoma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Behavioral
Intervention name:
Palliative Care
Description:
Best supportive care without surgical intervention
Arm group label:
Palliative Care
Other name:
Best Supportive Care
Intervention type:
Procedure
Intervention name:
Tumor biopsy
Description:
Tumor biopsy
Arm group label:
Tumor biopsy
Intervention type:
Procedure
Intervention name:
Tumor resection
Description:
Maximal safe resection of the tumor
Arm group label:
Tumor resection
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
18 Years
Maximum age:
90 Years
Locations:
Facility:
Name:
University of California, San Francisco
Address:
City:
San Francisco
Zip:
94143
Country:
United States
Status:
Recruiting
Contact:
Last name:
Mitchel Berger, MD PhD
Facility:
Name:
Massachusetts General Hospital
Address:
City:
Boston
Zip:
02114
Country:
United States
Status:
Recruiting
Contact:
Last name:
Brian Nahed, MD
Facility:
Name:
University Hospital Leuven
Address:
City:
Leuven
Country:
Belgium
Status:
Recruiting
Contact:
Last name:
Steven De Vleeschouwer, MD PhD
Facility:
Name:
Technical University Munich
Address:
City:
Munich
Zip:
74076
Country:
Germany
Status:
Not yet recruiting
Contact:
Last name:
Arthur Wagner, MD PhD
Facility:
Name:
University Hospital Heidelberg
Address:
City:
Heidelberg
Country:
Germany
Status:
Recruiting
Contact:
Last name:
Christine Jungk, Dr. med.
Facility:
Name:
Erasmus Medical Center
Address:
City:
Rotterdam
Zip:
3015 GD
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Jasper Gerritsen, MD PhD
Facility:
Name:
Haaglanden Medical Centre
Address:
City:
The Hague
Zip:
2512 VA
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Marike Broekman, MD PhD
Facility:
Name:
Inselspital Universitätsspital Bern
Address:
City:
Bern
Zip:
3010
Country:
Switzerland
Status:
Not yet recruiting
Contact:
Last name:
Philippe Schucht, MD PhD
Start date:
January 1, 2023
Completion date:
January 1, 2029
Lead sponsor:
Agency:
Jasper Gerritsen
Agency class:
Other
Collaborator:
Agency:
Haaglanden Medical Centre
Agency class:
Other
Collaborator:
Agency:
Universitaire Ziekenhuizen KU Leuven
Agency class:
Other
Collaborator:
Agency:
University Hospital Heidelberg
Agency class:
Other
Collaborator:
Agency:
Technical University of Munich
Agency class:
Other
Collaborator:
Agency:
Insel Gruppe AG, University Hospital Bern
Agency class:
Other
Collaborator:
Agency:
Massachusetts General Hospital
Agency class:
Other
Collaborator:
Agency:
University of California, San Francisco
Agency class:
Other
Source:
Erasmus Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06146738
