(FORWARD) A Phase 2, Historically Controlled Study Testing the Efficacy of TTFields (Optune®) with Adjuvant Temozolomide in High Risk WHO Grade II and III Astrocytomas

Purpose

The FORWARD study is a clinical trial at the University of Florida (Coordinating Center) with study sites across the country. These study sites are currently enrolling individuals with newly diagnosed with a high-risk astrocytoma (Grade II & Grade III brain tumor).

The purpose of this research study is to determine if treatment with Optune during maintenance cycles of Temozolomide is effective in the treatment of Grade II or III astrocytoma brain tumor(s).

Some molecular types of Grade II and III astrocytomas can behave like a more aggressive glioblastoma (GBM), and current treatment is suspected to be less effective on these tumors than other Grade II and III astrocytomas.

If you or a loved one may be eligible, continue to learn more about the study on this page or contact the study’s research coordinator Annie Allen:


Study sites

The University of Florida in Gainesville is the Coordinating Center for FORWARD. We can assist with locating the site closest to you.

Study site locations include:

  • California
  • Colorado
  • Florida
  • Massachusetts
  • Michigan
  • Minnesota
  • New York
  • North Carolina
  • Rhode Island
  • South Carolina
  • Texas

Eligibility 

The FORWARD study has specific criteria that must be matched in order to participate. If this does not apply to you, the study team would be happy to share additional clinical trials that you may be eligible for.

For this study, you must meet the following criteria:

  • You are 18 years or older
  • You have been diagnosed with astrocytoma or mixed oglioastrocytoma.
  • You are not more than 6 weeks after completion of chemo-radiation (i.e. you have not yet started adjuvant cycles of chemotherapy).

This study is for patients with a histopathologically-specific tumor type (tumor must exhibit all 3):

  1. 1p/19q intact per FISH and/or ATRX mutation(s)
  2. IDH1/2 wildtype
  3. TERT promoter mutation

For questions about eligibility criteria for the FORWARD study, please contact the study’s research coordinator Annie Allen:

Interested in other research opportunities? Learn more about our clinical trials here.


Study procedures

  • Adjuvant TMZ chemotherapy with precycle bloodwork
  • Optune device worn as much as possible
  • Periodic MRIs
  • Routine clinical appointments for monitoring purposes are required
  • Permission to use tumor tissue and MRI images for study
  • All patients in this study receive Temozolomide + TTFields; no placebo is used in this trial. Patients will begin treatment following chemoradiation and may continue up to 2 years.

The study team will outline detailed study procedures.

No compensation is offered; the patient is responsible for all deductible and copays associated with (standard) care received during the study.

Study Information Flyer

Age

18 to 65
65 and over

Gender

Male
Female

Monetary compensation

No

Can be done from home

No

Keywords

Brain tumor - primary - adults, Brain Tumors, Brain Tumor, FORWARD

Principal Investigator

Ashley Ghiaseddin, MD

Department

MD-Neurological Surgery

Contact Information

anne.allen@neurosurgery.ufl.edu

(352) 294-8836


Be an Informed Participant

Before deciding to participate in a research study, take time to learn about clinical research, how it's conducted and your rights as a research participant. Following are some helpful resources from independent sources. Always remember that a clinical research study is research, not treatment.

Know Who to Contact

  • Eligibility: For questions about a specific study and who is eligible to participate, call or email the contact person listed for that study.
  • Your Rights: For questions about your rights as a research participant, contact the UF Institutional Review Boards at 352-273-9600.
  • Feedback: For general questions or feedback about study listings, email the UF Clinical and Translational Science Institute at CTSI-Studies-L@lists.ufl.edu.

Other Resources

  • HealthStreet: Health-focused services, classes and events, and opportunities to participate in research.
  • ResearchMatch.org: Join a national registry of volunteers willing to be contacted about research studies.

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