vGRID SBRT: A Phase I Clinical Trial in Unresectable or Metastatic HCC
University of Kansas Medical Center
Summary
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.
Description
While 30 Gy in a single-dose SBRT has been demonstrated to be safe for liver tumors, higher radiation dose is likely required to control larger tumors. Radiation dose escalation beyond 30 Gy to the entire tumor will be significantly limited by potential toxicity to nearby tissues and organs. vGRID therapy, which treats part of the tumor to a high dose while the rest of the tumor to a lower dose, may allow safe dose escalation beyond 30 Gy. As described above, our treatment planning simulation has demonstrated an ability to safely dose escalate using the vGRID technique while keeping radiation…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria 1. Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent . 2. Males and females age ≥ 18 years. 3. ECOG Performance Status 0 - 1 4. Histologically confirmed hepatocellular carcinoma (HCC) or mixed HCC and cholangiocarcinoma either locally advanced or metastatic. 5. Not a candidate for surgical resection, or transplant 6. Child Pugh A - B7 liver function scale classification 14 days prior to entry. 7. Unresectable, locally-advanced or metastatic hepatocellular carcinom…
Interventions
- RadiationStereotactic Body Radiation Treatment
Single fraction SBRT 27 Gy
Location
- University of Kansas Medical CenterKansas City, Kansas