RecruitingNCT06146738

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


Sponsor

Jasper Gerritsen

Enrollment

1,015 participants

Start Date

Jan 1, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Inclusion Criteria3

  • Age ≥18 years and ≤90 years
  • Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon
  • Written informed consent

Exclusion Criteria4

  • 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

Interventions

BEHAVIORALPalliative Care

Best supportive care without surgical intervention

PROCEDURETumor biopsy

Tumor biopsy

PROCEDURETumor resection

Maximal safe resection of the tumor


Locations(8)

University of California, San Francisco

San Francisco, California, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

University Hospital Leuven

Leuven, Belgium

Technical University Munich

Munich, Bavaria, Germany

University Hospital Heidelberg

Heidelberg, Germany

Erasmus Medical Center

Rotterdam, South Holland, Netherlands

Haaglanden Medical Centre

The Hague, South Holland, Netherlands

Inselspital Universitätsspital Bern

Bern, Switzerland

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NCT06146738


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