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

Henry Ford Health

Status and phase: Completed; Phase 3

Conditions: Recurrent or Progressive Glioblastoma

Treatments: Drug: Bevacizumab; Radiation: Fractionated radiosurgery; Drug: Chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05718466

HFHS-C 11-01

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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35 participants in 2 patient groups

Fractionated Radiosurgery and Bevacizumab

Experimental group

Description:

FRS and Bev followed by Bev combined either Irinotecan or Temozolamide or Carboplatin or Etoposide until progression

Treatment:

Drug: Chemotherapy

Radiation: Fractionated radiosurgery

Drug: Bevacizumab

Bev with Chemo

Active Comparator group

Description:

Bev combined either Irinotecan or Temozolomide or Carboplatin or Etoposide until progression

Treatment:

Drug: Chemotherapy

Drug: Bevacizumab