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

NCT04365374 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 230

Last updated 2025-10-07

No results posted yet for this study

Summary

This trial will be a randomized controlled study comparing 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.

Conditions

Interventions

DEVICE

Gamma Tile-Surgically Targeted Radiation Therapy (STaRT)

GammaTiles are a permanently implanted radiation device consisting of Cs-131 seeds positioned within a collagen tile

RADIATION

Stereotactic Radiation Therapy

External Beam Radiation Therapy

Sponsors & Collaborators

  • GT Medical Technologies, Inc.

    lead INDUSTRY

Principal Investigators

  • Jeffrey Weinberg, MD · MD Anderson Cancer Center, Houston, TX

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-06
Primary Completion
2029-08-30
Completion
2029-08-30
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04365374 on ClinicalTrials.gov