The PALSUR-study: Palliative Care Versus Surgery in High-grade Glioma Patients (ENCRAM 2203)
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Palliative Care Best supportive care without surgical intervention |
Behavioral: Palliative Care
Best supportive care without surgical intervention
Other Names:
|
| Tumor biopsy Tumor biopsy |
Procedure: Tumor biopsy
Tumor biopsy
|
| Tumor resection Maximal safe resection of the tumor |
Procedure: Tumor resection
Maximal safe resection of the tumor
|
Outcome Measures
Primary Outcome Measures
- Overall survival [Up to 5 years postoperatively]
Time from diagnosis to death from any cause
- Quality of life at 3 months (EORTC QLQ C30) [3 months postoperatively]
Quality of life as assessed by the EORTC QLQ C30 questionnaire
- Quality of life at 3 months (EORTC QLQ BN20) [3 months postoperatively]
Quality of life as assessed by the EORTC QLQ BN20 questionnaire
- Quality of life at 3 months (EQ-5D) [3 months postoperatively]
Quality of life as assessed by the EQ-5D questionnaire
Secondary Outcome Measures
- Quality of life at 6 weeks (EORTC QLQ C30) [6 weeks postoperatively]
Quality of life as assessed by the EORTC QLQ C30 questionnaire
- Quality of life at 6 weeks (EORTC QLQ BN20) [6 weeks postoperatively]
Quality of life as assessed by the EORTC QLQ BN20 questionnaire
- Quality of life at 6 weeks (EQ-5D) [6 weeks postoperatively]
Quality of life as assessed by the EQ-5D questionnaire
- Quality of life at 6 months (EORTC QLQ C30) [6 months postoperatively]
Quality of life as assessed by the EORTC QLQ C30 questionnaire
- Quality of life at 6 months (EORTC QLQ BN20) [6 months postoperatively]
Quality of life as assessed by the EORTC QLQ BN20 questionnaire
- Quality of life at 6 months (EQ-5D) [6 months postoperatively]
Quality of life as assessed by the EQ-5D questionnaire
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age ≥18 years and ≤90 years
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Tumor diagnosed as HGG (WHO grade III/IV) on MRI as assessed by the neurosurgeon
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Written informed consent
Exclusion Criteria:
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Tumors of the cerebellum, brainstem or midline
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Inability to give written informed consent
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Secondary high-grade glioma due to malignant transformation from low-grade glioma
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of California, San Francisco | San Francisco | California | United States | 94143 |
| 2 | Massachusetts General Hospital | Boston | Massachusetts | United States | 02114 |
| 3 | University Hospital Leuven | Leuven | Belgium | ||
| 4 | Technical University Munich | Munich | Bavaria | Germany | 74076 |
| 5 | University Hospital Heidelberg | Heidelberg | Germany | ||
| 6 | Erasmus Medical Center | Rotterdam | Zuid-Holland | Netherlands | 3015 GD |
| 7 | Haaglanden Medical Centre | The Hague | Zuid-Holland | Netherlands | 2512 VA |
| 8 | Inselspital Universitätsspital Bern | Bern | Switzerland | 3010 |
Sponsors and Collaborators
- Jasper Gerritsen
- 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
Investigators
- Principal Investigator: Jasper Gerritsen, MD PhD, Erasmus Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MEC-2020-0812-4