GESTALT CLINICAL TRIAL for PATIENTS WITH NEWLY DIAGNOSED GLIOBLASTOMAS (GBMs)  | ENROLLING NOW

Trial FAQs

All clinical trial participants will receive both GammaTile® and the Stupp protocol.

Named after its founder, the Stupp protocol consists of external beam radiation therapy (EBRT) and oral chemotherapy with Temodar®, also called temozolomide, or TMZ.1 EBRT is delivered to the brain tumor or the area where the brain tumor was removed. Radiation and chemotherapy are combined to optimize treatment results.1

No, the total radiation administered in this clinical trial from both GammaTile and EBRT is within standard radiation treatment levels.

In many cases, yes. Previous or ongoing treatment with chemotherapy, targeted therapeutics, and immunotherapy is permitted, though it must comply with the specific clinical trial guidelines.
Participation may not delay your tumor removal surgery, but you must qualify and enroll about a week before your surgery. That’s why you should contact your participating hospital as soon as possible if you wish to enroll in this clinical trial.
If your surgery has been scheduled at a GESTALT Clinical Trial–participating hospital and it’s about a week away, you may still be able to participate in the clinical trial. Please contact the GESTALT Clinical Team ASAP to schedule an appointment. If your surgery is scheduled at a nonparticipating hospital, you may be eligible for a second opinion at a GESTALT Clinical Trial–participating hospital before your surgery.
Possibly, depending on the investigational drug, the clinical trial, and its exclusions. Please discuss this with your GESTALT Clinical Team and your medical care team.
Yes, the Stupp protocol standard of care is commonly used for patients with glioblastomas. In addition, you will receive FDA-cleared GammaTile Therapy. Further you will have the added benefit of the GESTALT Clinical Team closely overseeing your care.
Health insurance usually covers the cost of these FDA-cleared treatments. The GESTALT Clinical Team will confirm your insurance coverage before your enrollment.
Clinical trial participants at some, but not all, participating hospitals may be paid up to $50 per clinical trial visit. Ask your GESTALT Clinical Team for details.

Prior to your brain tumor–removal surgery, you’ll need to complete these study enrollment steps:

1. Schedule an appointment with the GESTALT Clinical Study team to confirm that you qualify for the study and take the screening tests.
2. Sign the informed consent study form.
3. Take a pregnancy test if you are a female of childbearing age.
4. Answer a questionnaire about your quality of life.
5. Take brain function assessments.

Next, the GESTALT Clinical Team will schedule your surgery, and you will be on track to receive your treatments. The first follow-up visit will be 28 +3 days after the start of cycle 4 of adjuvant temozolomide. Follow-up visit frequency will be:

  • Every 2 months +14 days for the first year
  • Every 4 months +21 days from 13 months after the first day of the last TMZ cycle
  • At 36 months from surgery

References:

  1. Stupp R, Mason WP, van den Bent MJ, et al. Radiotherapy plus concomitant and adjuvant temozolomide for glioblastoma. N Engl J Med. 2005;352(10):987-996.