Recruiting

Palliative Care vs. Surgery

Sponsor:

Jasper Gerritsen

Code:

NCT06146738

Conditions

Glioblastoma

Glioblastoma Multiforme

Glioblastoma, IDH-wildtype

Glioblastoma Multiforme, Adult

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Palliative Care

Tumor biopsy

Tumor resection

Study Details

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.

Conditions

Glioblastoma

Glioblastoma Multiforme

Glioblastoma, IDH-wildtype

Glioblastoma Multiforme, Adult

Study ID

NCT06146738

Start date

Jan 1, 2023

Status verified date

Nov, 2023

Completion date

Jan 1, 2029

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1015 participants

Anticipated

Interventions and Outcome Measures

Arms

Palliative Care

Best supportive care without surgical intervention

Tumor biopsy

Tumor biopsy

Tumor resection

Maximal safe resection of the tumor

Interventions

Palliative Care

Best supportive care without surgical intervention

Tumor biopsy

Tumor biopsy

Tumor resection

Maximal safe resection of the tumor

Primary outcome measure

  • Overall survival [ Time Frame: Up to 5 years postoperatively ]
  • Quality of life at 3 months (EORTC QLQ C30) [ Time Frame: 3 months postoperatively ]
  • Quality of life at 3 months (EORTC QLQ BN20) [ Time Frame: 3 months postoperatively ]
  • Quality of life at 3 months (EQ-5D) [ Time Frame: 3 months postoperatively ]

Central Contacts and Locations

Central contacts

Jasper Gerritsen, MD PhD

31107036130j.gerritsen@erasmusmc.nl

Arnaud Vincent, MD PhD

31107034211a.vincent@erasmusmc.nl

Locations

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

More Information

Sponsor

Jasper Gerritsen

Last update posted

Nov 27, 2023

Last verified

Nov, 2023

Keywords

  • Palliative care
  • Best supportive care
  • Biopsy
  • Resection
  • Quality of life
  • Survival
  • Glioblastoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jasper Gerritsen on 2023-11-27.