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JOURNAL ONKOLOGIE – STUDIE
PALSUR

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

Rekrutierend

NCT-Nummer:
NCT06146738

Studienbeginn:
Januar 2023

Letztes Update:
27.11.2023

Wirkstoff:
-

Indikation (Clinical Trials):
Glioblastoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Jasper Gerritsen

Collaborator:
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,

Studienleiter

Jasper Gerritsen, MD PhD
Principal Investigator
Erasmus Medical Center

Kontakt

Studienlocations
(3 von 8)

Alle anzeigen

Studien-Informationen

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.

Ein-/Ausschlusskriterien

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

Studien-Rationale

Primary outcome:

1. Overall survival (Time Frame - Up to 5 years postoperatively):
Time from diagnosis to death from any cause

2. 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

3. 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

4. Quality of life at 3 months (EQ-5D) (Time Frame - 3 months postoperatively):
Quality of life as assessed by the EQ-5D questionnaire

Secondary outcome:

1. Quality of life at 6 weeks (EORTC QLQ C30) (Time Frame - 6 weeks postoperatively):
Quality of life as assessed by the EORTC QLQ C30 questionnaire

2. Quality of life at 6 weeks (EORTC QLQ BN20) (Time Frame - 6 weeks postoperatively):
Quality of life as assessed by the EORTC QLQ BN20 questionnaire

3. Quality of life at 6 weeks (EQ-5D) (Time Frame - 6 weeks postoperatively):
Quality of life as assessed by the EQ-5D questionnaire

4. Quality of life at 6 months (EORTC QLQ C30) (Time Frame - 6 months postoperatively):
Quality of life as assessed by the EORTC QLQ C30 questionnaire

5. Quality of life at 6 months (EORTC QLQ BN20) (Time Frame - 6 months postoperatively):
Quality of life as assessed by the EORTC QLQ BN20 questionnaire

6. Quality of life at 6 months (EQ-5D) (Time Frame - 6 months postoperatively):
Quality of life as assessed by the EQ-5D questionnaire

Studien-Arme

  • Palliative Care
    Best supportive care without surgical intervention
  • Tumor biopsy
    Tumor biopsy
  • Tumor resection
    Maximal safe resection of the tumor

Geprüfte Regime

  • Palliative Care (Best Supportive Care):
    Best supportive care without surgical intervention
  • Tumor biopsy:
    Tumor biopsy
  • Tumor resection:
    Maximal safe resection of the tumor

Quelle: ClinicalTrials.gov


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