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

GESTALT Clinical Study
for patients with newly diagnosed glioblastomas (GBMs)

Sites Enrolling Now

Have you, or someone you know, been recently diagnosed with a glioblastoma?

If so, you should be aware of the opportunity to participate in the GESTALT Clinical Trial.

This clinical trial investigates how starting radiation immediately after brain tumor removal surgery can improve outcomes. All participants receive immediate radiation treatment with FDA-cleared, safe and effective GammaTile® Surgically Targeted Radiation Therapy (STaRT), followed by the Stupp protocol standard of care.1–3

Enrolling now at up to 20 hospitals across the country

Do you qualify for the clinical trial?

  • You have been newly diagnosed with 1 or more operable glioblastomas. 
  • You are 18 years old or older. 
  • You are not pregnant or planning a pregnancy.
  • You live within easy driving distance from this hospital.
  • You have not yet scheduled surgery, or your surgery is planned for about a week or more from today.

For more information contact a participating hospital.

Participating Hospitals

Learn more about the GESTALT Clinical Trial.

Background

Glioblastoma (GBM) is the most common primary malignant brain tumor in adults, yet effective treatment remains a challenge.4 The Stupp protocol standard of care for GBMs typically follows brain tumor removal surgery and includes external beam radiation therapy (EBRT) and oral chemotherapy with Temodar®, also called temozolomide or TMZ.1,4

A disadvantage of the Stupp protocol is that patients must wait for their surgical wounds to heal before they can start EBRT. Radiation treatment destroys cancer cells, shrinks tumors, and helps to prevent tumor regrowth.5 Since it typically takes 3- to 8-weeks to start EBRT, remaining tumor cells have the chance to repopulate.6,7 In fact, tumors regrow near the original area in up to 70% of patients while they are waiting for EBRT, lowering their chances of survival.1,8–11

Studies show that earlier radiation treatment may be more effective than later treatment.6,7 That’s why the GESTALT Clinical Trial starts GammaTile Therapy immediately at the completion of brain tumor removal surgery and follows with the Stupp protocol. The GESTALT Clinical Trial will provide more information on how starting radiation immediately, instead of waiting, can improve outcomes. This approach, when combined with EBRT and chemotherapy, has improved outcomes in patients with recurrent GBM and may offer the same benefit for newly diagnosed patients.12,13

About the clinical trial

As a GESTALT Clinical Trial participant, you will receive GammaTile for an immediate head STaRT against tumor regrowth. At the completion of your brain tumor surgery, the neurosurgeon will place the GammaTiles in the area that the tumor is most likely to return.2,3 Subsequently, you will receive the Stupp protocol standard of care treatment (consisting of 4 weekly cycles of EBRT + TMZ). The total radiation administered in this clinical trial is within standard radiation treatment levels.

The GESTALT Clinical Team will closely monitor your care. And you’ll be making a valuable contribution to future patients, helping to provide more information about how starting radiation immediately, instead of waiting, can improve outcomes.

Learn more about GammaTile and the Stupp protocol.

Clinical study FAQs

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.
  2. Brachman D, Youssef E, Dardis C, Smith K, Pinnaduwage D, Nakaji P. Surgically targeted radiation therapy: safety profile of collagen tile brachytherapy in 79 recurrent, previously irradiated intracranial neoplasms on a prospective clinical trial. Brachytherapy. 2019;18(3):S35-S36.
  3. GammaTile Therapy Instructions for Use. GT Medical Technologies; 2020.
  4. Tan AC, Ashley DM, López GY, Malinzak M, Friedman HS, Khasraw M. Management of glioblastoma: state of the art and future directions. CA Cancer J Clin. 2020;70(4):299-312.
  5. Stereotactic radiation therapy. RT Answers website. Accessed June 10, 2022. https://rtanswers.org/How-does-radiation-therapy-work/Stereotactic-Radiation-Therapy
  6. Do V, Gebski V, Barton MB. The effect of waiting for radiotherapy for grade III/IV gliomas. Radiother Oncol. 2000;57(2):131-136.
  7. Irwin C, Hunn M, Purdie G, Hamilton D. Delay in radiotherapy shortens survival in patients with high-grade glioma. J Neurooncol. 2007;85(3):339-343.
  8. Pennington C, Kilbride L, Grant R, Wardlaw JM. A pilot study of brain tumour growth between radiotherapy planning and delivery. Clin Oncol (R Coll Radiol). 2006;18(2):104-108.
  9. Waters JD, Rose B, Gonda DD, et al. Immediate post-operative brachytherapy prior to irradiation and temozolomide for newly diagnosed glioblastoma. J Neurooncol. 2013;113(3):467-477.
  10. Buszek SM, Al Feghali KA, Elhalawani H, Chevli N, Allen PK, Chung C. Optimal timing of radiotherapy following gross total or subtotal resection of glioblastoma: a real-world assessment using the National Cancer Database. Sci Rep. 2020;10(1):4926.
  11. Wallner KE, Galicich JH, Krol G, Arbit E, Malkin MG. Patterns of failure following treatment for glioblastoma multiforme and anaplastic astrocytoma. Int J Radiat Oncol Biol Phys. 1989;16(6):1405-1409.
  12. Smith K, Nakaji P, Thomas T, et al. Safety and patterns of survivorship following resection and surgically targeted radiation therapy: results from a prospective trial. J Neurooncol. Forthcoming 2022.
  13. Gessler DJ, Neil EC, Shah R, et al. GammaTile® brachytherapy in the treatment of recurrent glioblastomas. Neurooncol Adv. 2021;4(1):vdab185. Published 2021 Dec 27. doi:10.1093/noajnl/vdab185

The GESTALT Trial is sponsored by GT Medical Technologies, Inc., the makers of GammaTile®. Please discuss the risks and benefits of participating in this clinical trial with your care team.

Indication: GammaTile is indicated as a treatment for patients with newly diagnosed malignant intracranial neoplasms and recurrent intracranial neoplasms.

Safety Information: The potential for, and symptoms of, adverse events related to radiation exposure vary depending on the radiosensitivity of the exposed tissue, the amount of radiation delivered, and the placement of GammaTile(s). GammaTile should not be used for patients with a known history of hypersensitivity to bovine-derived materials.

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

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