Stereotactic Body Proton Radiotherapy for the Treatment of Liver Cancer

NCT04805788 | Terminated Phase 2

• 3 other identifiers: MC200804NCI-2021-0135720-005638
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

This phase II trial studies the effect of stereotactic body proton radiotherapy in treating patients with liver cancer. Proton radiotherapy is a type of treatment that uses high-energy beams to treat tumors.

Conditions

Stage I Hepatocellular Carcinoma AJCC v8; Recurrent Hepatocellular Carcinoma; Stage II Hepatocellular Carcinoma AJCC v8; Stage III Hepatocellular Carcinoma AJCC v8

Outcome Measures

Primary Outcomes (1)

• 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)

  The rate will be estimated and a 95% exact binomial confidence interval reported, and then tested utilizing a one-sample test for proportions versus the historical control of 15%.

  3 months

Secondary Outcomes (8)

• 3-month complication rate

  3 months

• Incidence of late toxicity

  Up to 2 years

• 6-month local control

  6 months

• Liver disease control

  Up to 2 years

• Progression free survival

  Up to 2 years

Other Outcomes (4)

• Patient-reported outcomes

  Up to 2 years

• Clinical features, treatment technique, and dose-volume parameters

  Up to 2 years

• Value of additional imaging analyses and techniques

  Up to 2 years

Study Arms (1)

Treatment (SBPT)

EXPERIMENTAL

Patients undergo 1 SBPT fraction over 20-30 minutes per day for a total of 5 fractions.

Radiation: Proton Stereotactic Body Radiation Therapy; Other: Quality-of-Life Assessment

Interventions

Proton Stereotactic Body Radiation Therapy RADIATION

Undergo SBPT

Also known as: Proton SBRT

Treatment (SBPT)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Treatment (SBPT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>= 18 years
• Radiologically presumed or histologically proven, newly diagnosed or recurrent, hepatocellular carcinoma
• Clinical stage T0-T4N0M0 (American Joint Committee on Cancer \[AJCC\] 8th edition).
• One to three discrete Liver Reporting and Data System-5 (LIRADS-5) lesions that can be encompassed within a single radiation treatment plan
• Patients treated with external beam radiation as a bridge to transplant are allowed
• Minimum single lesion size \>= 1 cm, maximum cumulative diameter =\< 15 cm
• Vascular involvement (including portal vein, inferior vena cava \[IVC\] and/or hepatic vein) is allowed
• Target lesion must be amenable to a SBRT regimen utilizing proton beam therapy (i.e. SBPT)
• Prior local liver treatment including surgery, percutaneous ablation, transarterial bland or chemoembolization (TACE), or Y-90 radioembolization is allowed if completed at least 6 weeks prior to treatment start date
• Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 to 2
• Life expectance \>= 3 months based on medical comorbidities, tumor extent and other clinical factors as determined by treating physician
• Child Pugh score of A or B7
• Absolute neutrophil count (ANC) \>= 1000 cells/mm\^3 (within 45 days of study entry)
• Platelets (Plt) \>= 30,000 cells/mm\^3 (the use of transfusion or other intervention to achieve the minimum platelet level is allowed) (within 45 days of study entry)
• Hemoglobin (Hgb) \>= 8.0 g/dL (the use of transfusion or other intervention to achieve the minimum hemoglobin level is allowed) (within 45 days of study entry)

You may not qualify if:

• Medical contraindication to receipt of radiotherapy
• Severe active co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
• Uncontrolled concurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or providing informed consent
• Active systemic lupus or scleroderma
• Women of childbearing potential who are sexually active and not willing/able to use medically acceptable forms of contraception
• Prior receipt of external beam radiation to the current active disease site or if additional radiotherapy to the current site would be unsafe as determined by the treating radiation oncologist
• More than 3 LIRADS-5 lesions or disease extent such that organ at risk constraints cannot be met
• Tumor extension into common or main branch biliary duct or adjacent organs including stomach, small or large bowel
• Extrahepatic metastases or lymph node involvement
• History of other malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 1 year prior to study entry
• Patient is unable to undergo intravenous contrast enhanced liver imaging (either computed tomography \[CT\] or magnetic resonance imaging \[MRI\]) based on clinical imaging protocols established at the treating institution

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Jonathan B. Ashman, M.D., Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2021
• First Posted: March 18, 2021
• Study Start: August 24, 2021
• Primary Completion: February 15, 2024
• Study Completion: January 28, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

US (2)