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

NCT ID: NCT06146738

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1015 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2029-01-01

Brief Summary

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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

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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

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Glioblastoma Glioblastoma Multiforme Glioblastoma, IDH-wildtype Glioblastoma Multiforme, Adult

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Palliative Care

Best supportive care without surgical intervention

Palliative Care

Intervention Type BEHAVIORAL

Best supportive care without surgical intervention

Tumor biopsy

Tumor biopsy

Tumor biopsy

Intervention Type PROCEDURE

Tumor biopsy

Tumor resection

Maximal safe resection of the tumor

Tumor resection

Intervention Type PROCEDURE

Maximal safe resection of the tumor

Interventions

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Palliative Care

Best supportive care without surgical intervention

Intervention Type BEHAVIORAL

Tumor biopsy

Tumor biopsy

Intervention Type PROCEDURE

Tumor resection

Maximal safe resection of the tumor

Intervention Type PROCEDURE

Other Intervention Names

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Best Supportive Care

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Haaglanden Medical Centre

OTHER

Sponsor Role collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role collaborator

University Hospital Heidelberg

OTHER

Sponsor Role collaborator

Technical University of Munich

OTHER

Sponsor Role collaborator

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role collaborator

Jasper Gerritsen

OTHER

Sponsor Role lead

Responsible Party

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Jasper Gerritsen

Jasper K.W. Gerritsen MD PhD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Jasper Gerritsen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

University Hospital Leuven

Leuven, , Belgium

Site Status RECRUITING

Technical University Munich

Munich, Bavaria, Germany

Site Status NOT_YET_RECRUITING

University Hospital Heidelberg

Heidelberg, , Germany

Site Status RECRUITING

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

Site Status RECRUITING

Haaglanden Medical Centre

The Hague, South Holland, Netherlands

Site Status RECRUITING

Inselspital Universitätsspital Bern

Bern, , Switzerland

Site Status NOT_YET_RECRUITING

Countries

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United States Belgium Germany Netherlands Switzerland

Central Contacts

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Jasper Gerritsen, MD PhD

Role: CONTACT

[email protected]
31107036130

Arnaud Vincent, MD PhD

Role: CONTACT

[email protected]
31107034211

Facility Contacts

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Mitchel Berger, MD PhD

Role: primary

Brian Nahed, MD

Role: primary

Steven De Vleeschouwer, MD PhD

Role: primary

Arthur Wagner, MD PhD

Role: primary

Christine Jungk, Dr. med.

Role: primary

Jasper Gerritsen, MD PhD

Role: primary

Marike Broekman, MD PhD

Role: primary

Philippe Schucht, MD PhD

Role: primary

Other Identifiers

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MEC-2020-0812-4

Identifier Type: -

Identifier Source: org_study_id