GlioblastomaPALSURNCT06146738
The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)
An observational study of Glioblastoma and Glioblastoma Multiforme, run by Jasper Gerritsen at 8 sites in 5 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Glioblastoma, Glioblastoma Multiforme, Glioblastoma, IDH-wildtype
- What is being tested?
- Palliative Care, Tumor biopsy and Tumor resection
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- How many people
- 1,015 participants
- Where
- 8 sitesin 5 countries
- Study dates
- 1 Jan 2023to 1 Jan 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Age ≥18 years and ≤90 years
- Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
8 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 5 countries
United States2 sites, 2 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brian Nahed, MD
- Recruiting
University of California, San Francisco
San Francisco, California, 94143
Mitchel Berger, MD PhD
Germany2 sites, 2 recruiting
- Recruiting
University Hospital Heidelberg
Heidelberg
Christine Jungk, Dr. med.
- Not yet recruiting
Technical University Munich
Munich, Bavaria, 74076
Arthur Wagner, MD PhD
Netherlands2 sites, 2 recruiting
- Recruiting
Erasmus Medical Center
Rotterdam, South Holland, 3015 GD
Jasper Gerritsen, MD PhD
- Recruiting
Haaglanden Medical Centre
The Hague, South Holland, 2512 VA
Marike Broekman, MD PhD
Belgium1 site, 1 recruiting
- Recruiting
University Hospital Leuven
Leuven
Steven De Vleeschouwer, MD PhD
Switzerland1 site, 1 recruiting
- Not yet recruiting
Inselspital Universitätsspital Bern
Bern, 3010
Philippe Schucht, MD PhD
About this study
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.
Read the 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.
- Conditions
- Glioblastoma, Glioblastoma Multiforme, Glioblastoma, IDH-wildtype, Glioblastoma Multiforme, Adult
- Being tested
- Palliative Care, Tumor biopsy, Tumor resection
- Keywords
- Palliative care, Best supportive care, Biopsy, Resection, Quality of life, Survival, Glioblastoma
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Palliative CareBehavioural
Also called Best Supportive Care
Best supportive care without surgical intervention
Tumor biopsyProcedure or surgery
Tumor biopsy
Tumor resectionProcedure or surgery
Maximal safe resection of the tumor
| Study group | Role | What they receive |
|---|---|---|
| Palliative Care | Best supportive care without surgical intervention Receives: Behavioral: Palliative Care | |
| Tumor biopsy | Tumor biopsy Receives: Procedure: Tumor biopsy | |
| Tumor resection | Maximal safe resection of the tumor Receives: Procedure: Tumor resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival
Time from diagnosis to death from any cause
Measured: Up to 5 years postoperatively
Quality of life at 3 months (EORTC QLQ C30)
Quality of life as assessed by the EORTC QLQ C30 questionnaire
Measured: 3 months postoperatively
Quality of life at 3 months (EORTC QLQ BN20)
Quality of life as assessed by the EORTC QLQ BN20 questionnaire
Measured: 3 months postoperatively
Quality of life at 3 months (EQ-5D)
Quality of life as assessed by the EQ-5D questionnaire
Measured: 3 months postoperatively
Secondary outcomes (6)
Quality of life at 6 weeks (EORTC QLQ C30)
Quality of life as assessed by the EORTC QLQ C30 questionnaire
Measured: 6 weeks postoperatively
Quality of life at 6 weeks (EORTC QLQ BN20)
Quality of life as assessed by the EORTC QLQ BN20 questionnaire
Measured: 6 weeks postoperatively
Quality of life at 6 weeks (EQ-5D)
Quality of life as assessed by the EQ-5D questionnaire
Measured: 6 weeks postoperatively
Quality of life at 6 months (EORTC QLQ C30)
Quality of life as assessed by the EORTC QLQ C30 questionnaire
Measured: 6 months postoperatively
Quality of life at 6 months (EORTC QLQ BN20)
Quality of life as assessed by the EORTC QLQ BN20 questionnaire
Measured: 6 months postoperatively
Quality of life at 6 months (EQ-5D)
Quality of life as assessed by the EQ-5D questionnaire
Measured: 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2023
- Study start1 Jan 2023
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,015 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jasper Gerritsen
- Sponsor type
- University, hospital or other
- Collaborators
- Haaglanden Medical Centre, Universitaire Ziekenhuizen KU Leuven, University Hospital Heidelberg, Technical University of Munich, Insel Gruppe AG, University Hospital Bern, Massachusetts General Hospital, University of California, San Francisco
- Responsible party
- Sponsor-investigator, Jasper Gerritsen, Erasmus Medical Center
- Investigators
- Jasper Gerritsen, MD PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06146738
- Sponsor's protocol ID
- MEC-2020-0812-4
- Acronym
- PALSUR
- Status last verified
- Nov 2023
- First submitted
- 18 Nov 2023
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)
- ClinicalTrials.gov ID
- NCT06146738
- Acronym / sponsor ID
- PALSUR / MEC-2020-0812-4
- Conditions
- Glioblastoma, Glioblastoma Multiforme, Glioblastoma, IDH-wildtype, Glioblastoma Multiforme, Adult
- Keywords
- Palliative care, Best supportive care, Biopsy, Resection, Quality of life, Survival, Glioblastoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,015 participants (estimated)
- Lead sponsor
- Jasper GerritsenUniversity, hospital or other
- Collaborators
- Haaglanden Medical Centre, Universitaire Ziekenhuizen KU Leuven, University Hospital Heidelberg, Technical University of Munich, Insel Gruppe AG, University Hospital Bern, Massachusetts General Hospital, University of California, San Francisco
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 27 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Palliative Care | – | Behavioral: Palliative CareBest supportive care without surgical intervention |
| Tumor biopsy | – | Procedure: Tumor biopsyTumor biopsy |
| Tumor resection | – | Procedure: Tumor resectionMaximal safe resection of the tumor |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age ≥18 years and ≤90 years
- Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon
- Written informed consent
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Palliative CareAlso: Best Supportive CareBest supportive care without surgical intervention | Behavioural | Palliative Care |
| Tumor biopsyTumor biopsy | Procedure or surgery | Tumor biopsy |
| Tumor resectionMaximal safe resection of the tumor | Procedure or surgery | Tumor resection |
Primary outcome
Overall survival
Time frame: Up to 5 years postoperatively
Time from diagnosis to death from any cause
Quality of life at 3 months (EORTC QLQ C30)
Time frame: 3 months postoperatively
Quality of life as assessed by the EORTC QLQ C30 questionnaire
Quality of life at 3 months (EORTC QLQ BN20)
Time frame: 3 months postoperatively
Quality of life as assessed by the EORTC QLQ BN20 questionnaire
Quality of life at 3 months (EQ-5D)
Time frame: 3 months postoperatively
Quality of life as assessed by the EQ-5D questionnaire
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Glioblastoma
Active, not recruitingPhase 1
A Trial of Belzutifan (PT2977, MK-6482) Tablets In Patients With Advanced Solid Tumors (MK-6482-001)
Advanced Solid Tumors, Solid Tumor
Active, not recruitingPhase 2
A Study Testing the Effect of Immunotherapy (Ipilimumab and Nivolumab) in Patients With Recurrent Glioma With Elevated Mutational Burden
Astrocytoma, IDH-Mutant, Grade 4, Diffuse Glioma
Active, not recruitingPhase 1/2
Ultrasound-based Blood-brain Barrier Opening and Albumin-bound Paclitaxel and Carboplatin for Recurrent Glioblastoma
Glioblastoma, Gliosarcoma
Active, not recruitingPhase 1
Safety and Efficacy Study of Anti-B7-H3 CAR-T Cell Therapy for Recurrent Glioblastoma
Glioblastoma
RecruitingPhase 2
Temozolomide, With or Without WSD0922-FU, for the Treatment of EGFR-Mutant, IDH-Wildtype Glioblastoma
Glioblastoma, IDH-Wildtype
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jasper Gerritsen, MD PhD principal investigator
Erasmus Medical Center
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma and Glioblastoma Multiforme, run by Jasper Gerritsen at 8 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Germany, Netherlands, Belgium, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jasper Gerritsen, MD PhD (31107036130, j.gerritsen@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (time frame: Up to 5 years postoperatively). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023; AzTrials last refreshed its copy on 26 Oct 2026.