vGRID SBRT: A Phase I Clinical Trial in Unresectable or Metastatic HCC

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
University of Kansas Medical Center
Study ID
NCT05727787
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Stereotactic Body Radiation Treatment — RADIATION
    Single fraction SBRT 27 Gy

Study Details

This trial will provide the maximum tolerated dose for radiation therapy for liver tumors and describe the toxicity profile using the vGRID therapy technique. Based on trials using this type of radiation in other cancers demonstrating low toxicity rates even with very high radiation doses and high efficacy, it is likely that vGRID therapy in this trial will be well tolerated and allow dose escalation beyond currently common doses for liver tumors.

Key Dates

Start date
Feb 23, 2023
Status verified
Apr 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Single fraction SBRT 27 Gy
    vGRID SBRT 3+3 dose escalation, single fraction, one day cycle length

Primary Outcome Measure

Maximum tolerated dose (MTD) of Single Fraction GRID SBRT [ Time Frame: First day of post-GRID SBRT through 3 month post-radiation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Kansas Medical CenterKansas CityKansas66160
Amanda Schroeder, MPH
913-588-3600
Maggie Messplay, BS
913-588-3610
David Akhavan, MD (PRINCIPAL_INVESTIGATOR)

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