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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05718466
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Henry Ford Health System
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Farzan Siddiqui, MD
Principal Investigator Affiliation Henry Ford Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Completed
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Recurrent or Progressive Glioblastoma
Arms & Interventions

Arms

Experimental: Fractionated Radiosurgery and Bevacizumab

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

Active Comparator: Bev with Chemo

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

Interventions

Drug: - Bevacizumab

Drug: - Chemotherapy

Radiation: - Fractionated radiosurgery

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Henry Ford Health System, Detroit, Michigan

Status

Address

Henry Ford Health System

Detroit, Michigan, 48202