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Completed

NCT Number: NCT05718466

Stereotactic Radiology Versus Chemotherapy for Recurrent/Progressive Glioblastoma After Second-Line Chemotherapy

This clinical trial is a prospective study of radiosurgery treatment for progressive GBM to test 1)the efficacy of radiosurgery for recurrent/progressive GBM compared to chemotherapy , and 2) the role of diffusion-weighted image (DWI) to predict the early tumor progression and treatment response.

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Key information

Conditions

Recurrent or Progressive Glioblastoma Astrocytoma Disease Attributes Glioblastoma Glioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Histologically proven intracranial glioblastoma multiforme with pathologic or imaging confirmation of tumor progression or regrowth after failure of two previous treatment regimens
  • Initial low-grade glioma and a subsequent diagnosis of glioblastoma or gliosarcoma
  • History and physical exam, including neurologic examination, within 4 weeks prior to registration

Exclusion criteria

  • Warfarin or LMW heparin patients must have no active bleeding or pathological condition that carries a high risk of bleeding

Treatment and study plan

Bevacizumab

Drug

Chemotherapy

Drug

Other names: Either irinotecan or temozolomide or carboplatin or etoposide

Fractionated radiosurgery

Radiation

Primary outcomes

  1. Local Tumor Control

    Time frame: 2 months

  2. Overall Survival

    Time frame: 12 months

  3. Progression Free Survival

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Henry Ford Health System

Other

Registry information

Official study title

Prospective Study of Stereotactic Radiosurgery Using Diffusion-Weighted Abnormality Versus Chemotherapy for Recurrent/Progressive Glioblastoma After Second-line Chemotherapy

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Feb 8, 2023
Registry last updated
Jul 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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