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

Phase 3

Completed

• Conditions: Recurrent or Progressive Glioblastoma
• Interventions: Drug: Bevacizumab; Drug: Chemotherapy; Radiation: Fractionated radiosurgery

• Registration Number: NCT05718466
• Lead Sponsor: Henry Ford Health System

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2014-02-26
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Study First Submitted QC: 2023-01-30
• Study First Posted: 2023-02-08
• Status Verified: 2023-06
• Results First Submitted: 2023-06-23
• Results First Submitted QC: 2023-06-23
• Last Update Submitted: 2023-06-23
• Results First Posted: 2023-07-17
• Last Update Posted: 2023-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fractionated Radiosurgery and Bevacizumab	Chemotherapy	FRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression
Fractionated Radiosurgery and Bevacizumab	Fractionated radiosurgery	FRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression
Bev with Chemo	Chemotherapy	Bev combined either Irinotecan or Temozolomide or Carboplatin or Etoposide until progression
Fractionated Radiosurgery and Bevacizumab	Bevacizumab	FRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression
Bev with Chemo	Bevacizumab	Bev combined either Irinotecan or Temozolomide or Carboplatin or Etoposide until progression

Primary Outcome Measures

Name	Time	Method
Progression Free Survival	12 months
Overall Survival	12 months
Local Tumor Control	2 months

Trial Locations

Locations (1)

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States