Role of Repeat Resection in Recurrent Glioblastoma

NCT04838782 | Withdrawn DMC

• 1 other identifier: CC-210049
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with recurrent Glioblastoma (GBM) are commonly presented to surgeons, along with the question of whether or not to re-resect the recurrence. There is no Level 1 evidence to support a role for repeat surgery in this context, but a multitude of observational research suggests that repeat surgery may improve quality survival. Unfortunately, these studies all suffer from selection bias. The goal of this study is to provide a care trial context to help neurosurgeons manage patients presenting with recurrent GBM, with no additional risks, tests, or interventions than what they would normally encounter in routine care. Secondary goals include a test of the hypothesis that repeat resection can improve median overall survival, and that it can increase the number of days of survival outside of a hospital/nursing/palliative care facility.

Conditions

Recurrent Glioblastoma; Glioblastoma - Category

Keywords

rGBM, repeat GBM, recurrent high grade astrocytoma

Outcome Measures

Primary Outcomes (1)

• Length of Overall Survival

  The primary outcome is time to death from any cause, starting from the time of inclusion.

  Follow-up for 5 Years or until death

Secondary Outcomes (5)

• Total length of hospitalization / palliative care / nursing home

  Follow-up for 5 Years or until death

• Discharge to a location other than home

  Follow-up for 5 Years or until death

• Total number of days spent outside a hospital or nursing care facility.

  Follow-up for 5 Years or until death

• Incidence of peri-operative non-neurological complications (wound infection, CSF leaks)

  Follow-up for 5 Years or until death

• Incidence of new significant neurological deficits after surgery (defined as new or substantially worsened aphasia, or new weakness (MRC power < 3 in one or more limbs).

  Follow-up for 5 Years or until death

Study Arms (2)

Repeat Surgical Resection

EXPERIMENTAL

Standard surgical operative management according to local practices.

Procedure: Repeat Surgical Management of Recurrent GBM

Management Without Re-operation

ACTIVE COMPARATOR

Non-surgical management with standard care according to local practices.

Procedure: Repeat Surgical Management of Recurrent GBM

Interventions

Repeat Surgical Management of Recurrent GBM PROCEDURE

Routine of surgical operative management. Details of treatment will be left to local centers, and recorded in the case report form (CRF).

Management Without Re-operation; Repeat Surgical Resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Previously histologically confirmed and surgically resected Glioblastoma
• Previous craniotomy for open tumor resection (needle biopsies alone do not count as resection)
• The attending surgeon considers re-operation may improve quality survival

You may not qualify if:

• Informed consent not possible

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Division of Neurosurgery

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (24)

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MeSH Terms

Conditions

Glioblastoma; Astrocytoma

Condition Hierarchy (Ancestors)

Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2021
• First Posted: April 9, 2021
• Study Start: August 26, 2021
• Primary Completion: March 24, 2025
• Study Completion: March 24, 2025
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Indefinitely

Locations

CA (1)