Post-Surgical Stereotactic Radiotherapy (SRT) Versus GammaTile-ROADS (Radiation One and Done Study)

A
Angela M. Richardson, MD, PhD

Primary Investigator

Enrolling By Invitation
18 years or above
All
Phase 3
180 participants needed
2 Locations

Brief description of study

What is the purpose of this study?
This trial will be a randomized controlled study comparing the efficacy and safety ofve radiation therapy using GammaTilesTM (GT) versus SRS 3-4 weeks followingumor resection which is the current standard of care.

THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.

Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

What will happen during the study?
  • GammaTile therapy results in improved clinical outcomes; however the data is a single site experience with a limited number of subjects, only 12 of which were patients with metastatic brain tumors. 
  • The primary objective of this randomized, controlled trial is to compare the efficacy and safety of intraoperative radiation therapy using GammaTilesTM (GT) versus SRT 3-4 weeks following metastatic tumor resection which is the current standard of care. 
  • The data collected in this trial design will allow for a direct comparisons of a variety of outcomes including local control, overall survival, functional status, quality of life, neurocognitive status and safety in the target population. 
  • In order to support direct comparisons, subjects will be randomized to the two equally sized arms (1:1) based on the following stratification factors; age (<60 and ≥60), duration of extracranial disease control (≤3 months vs >3 months), number of metastases (one vs multiple), histology (lung and radiation resistant), and the maximal diameter of the index lesion (≤3 cm and >3 cm) and use of prior or current immunotherapy (yes vs no).

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Brain Metastases
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:
  1. Patients aged 18 years old and above. Eligibility is restricted to this age groupgiven that the battery of neurocognitive tests utilized in this protocol are notdeveloped or validated for use in a younger population.
  2. One to four newly diagnosed brain metastases, identified on the screening MRI, from any tumor.
  3. One lesion, designated the index lesion, is planned for surgical resection and is tobe between 2.5 cm and 5.0 cm on the screening MRI. Index lesions > 2.0 cm but <2.5 cmgible if surgery is deemed clinically necessary and appropriate for and gross total resection by the neurosurgeon.
  4. Non-index lesions must measure < 4.0 cm in maximal extent on the screening MRI brain. The unresected lesions will be treated with SRT as outlined in the treatmenthe concept.
  5. All metastases must be located > 5 mm from the optic chiasm and outside the brainstem.Dural based metastasis are eligible.
  6. Previous and/or concurrent treatment with systemic therapies (e.g., chemotherapy,geted therapeutics, immunotherapy) is permitted and must follow protocol guidelinesws: Systemic therapy is allowed a minimum of one week from last systemicherapy cycle to surgical resection, and one week after surgical resection to allow aum of one week before starting/resuming systemic therapy, depending on theystemic agent(s), as recommended by medical/neuro-oncology. Systemic therapywed 1 day before SRT, the same day as the SRT, or 1 day after thehe SRT or longer, depending on the specific systemic agent(s), asded by medical/neuro-oncology. Agents that are delivered by implant or depotjections (such as hormonal therapies) are excluded from these restrictions.
  7. KPS score of ≥70.
  8. Stable systemic disease or reasonable systemic treatment options predicting a lifey of ≥6 months.
  9. Ability to complete an MRI of the head with contrast
  10. Adequate renal and hepatic function to undergo surgery, in investigators opinion.
  11. For women of childbearing potential only, a negative urine or serum pregnancy testdone < 7 days prior to randomization is required. Women must be willing to notifyvestigator immediately if they become pregnant at any time during the trial period.
  12. Men and women of childbearing potential must be willing to employ adequatehroughout the study and for men for up to 3 months after completing.
  13. Subjects must be fluent in English language to allow for completion of neurocognitived completion of QOL questionnaires. Non-English speaking subjects are notd to participate given that participation in the real time integratedurocognitive function tests is mandatory for all patients. The psychometricd tests are either not known or not as robust.
  14. Willingness and ability to provide written informed consent and HIPAA authorizationy study-related procedures.
Exclusion Criteria
  1. Age <18 years.
  2. KPS<70
  3. Past radiation or surgical therapy to the index lesion or the newly diagnoseddex lesion(s) is exclusionary. However, up to a total of 2 prior courses of SRTviously diagnosed lesions are allowed as long as any treated lesionswere >15mm from the index lesion.
  4. Patients with >4 newly diagnosed metastases on screening MRI
  5. Pregnant patients.
  6. Primary germ cell tumor, small cell carcinoma, or lymphoma.
  7. Leptomeningeal metastasis (LMD). Note: For the purposes of exclusion, LMD is adiagnosis, defined as radiologic or clinical evidence of leptomeningealvolvement with or without positive cerebrospinal fluid (CSF) cytology.
  8. Prior WBRT for brain metastases.
  9. Concomitant therapy that, in the investigator's opinion, would interfere with thevaluation of the safety or efficacy of the study device.
  10. Comorbid psychiatric or neurologic disease or injury impacting cognition, in thehe treating physician, that might impair patient's ability to understandy with the requirements of the study or to provide consent
  11. Subjects who, in the investigator's opinion, are unable to understand the protocol orgive informed consent, have a history of poor cooperation, noncompliance withdical treatment, or difficulty in returning for follow up care.

Updated on 13 Dec 2024. Study ID: GTM-102, SNEU-GTMEDICAL-NEW-METS, 14146
Please visit our main page to search for other studies you may be interested in. If you need help finding a study or have any questions, please contact us at inhealth@iu.edu

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

Contact a study center