Proton Stereotactic Body Radiation Therapy for Hepatocellular Carcinoma

Mayo Clinic in Rochester, Rochester, MN
Hepatocellular Carcinoma+7 More ConditionsProton Stereotactic Body Radiation Therapy - Radiation
All Sexes
What conditions do you have?

Study Summary

This trial will test whether proton radiotherapy is effective in treating patients with liver cancer.

Eligible Conditions
  • Stage IA Hepatocellular Carcinoma
  • Hepatocellular Carcinoma (HCC)
  • Stage IIIB Hepatocellular Carcinoma
  • Stage IIIA Hepatocellular Carcinoma
  • Stage IB Hepatocellular Carcinoma
  • Stage I Liver Cancer
  • Stage III Liver Cancer
  • Stage II Liver Cancer

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
Phase 2

Study Objectives

1 Primary · 10 Secondary · Reporting Duration: Up to 2 years

3 months
3-month complication rate
3-month rate of patients experiencing an increase in Child-Pugh score by 2 or more points of 5-fraction stereotactic body proton radiotherapy in the treatment of hepatocellular carcinoma (HCC)
6 months
6-month local control
Imaging response rates
RECIST criteria will be used to defined local control/local failure
Value of volumetric imaging analysis
Up to 2 years
Blood bank patient specimens for future analysis
Clinical features, treatment technique, and dose-volume parameters
Incidence of late toxicity
Liver disease control
Intrahepatic Cholestasis
Overall survival
Patient-reported outcomes
Progression free survival
Value of additional imaging analyses and techniques

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

1 Treatment Group

Treatment (SBPT)
1 of 1

Experimental Treatment

60 Total Participants · 1 Treatment Group

Primary Treatment: Proton Stereotactic Body Radiation Therapy · No Placebo Group · Phase 2

Treatment (SBPT)Experimental Group · 2 Interventions: Proton Stereotactic Body Radiation Therapy, Quality-of-Life Assessment · Intervention Types: Radiation, Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,007 Previous Clinical Trials
3,512,820 Total Patients Enrolled
7 Trials studying Hepatocellular Carcinoma
2,985 Patients Enrolled for Hepatocellular Carcinoma
National Cancer Institute (NCI)NIH
13,274 Previous Clinical Trials
41,234,652 Total Patients Enrolled
42 Trials studying Hepatocellular Carcinoma
6,067 Patients Enrolled for Hepatocellular Carcinoma
Jonathan B AshmanPrincipal InvestigatorMayo Clinic

Eligibility Criteria

Age 18+ · All Participants · 3 Total Inclusion Criteria

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Frequently Asked Questions

What adverse effects have been seen in people who undergo Proton Stereotactic Body Radiation Therapy?

"We assessed the safety of Proton Stereotactic Body Radiation Therapy to be a 2 as this is still in Phase 2, thus there are some evidence-based findings that suggest its security but not efficacy." - Anonymous Online Contributor

Unverified Answer

What is the current projected sample size of this clinical trial?

"Yes, public records from demonstrate that this medical research initiative began recruiting patients on February 4th 2021 and has since been updated on May 11th 2022. The investigators aim to enroll 60 participants across two sites." - Anonymous Online Contributor

Unverified Answer

Is this medical trial still accepting participants?

"Per documentation found on, this medical research is still open for enrollment and was last modified in May of 2022; it had initially been posted to the site 6 months prior." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.