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Personalized Adaptive Radiotherapy for Hepatocellular Carcinoma
Sponsor: University Health Network, Toronto
Summary
This study evaluates whether Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy (PULSAR) improves overall survival compared with best supportive care (BSC). The main questions this study aims to answer are: Does PULSAR improve overall survival compared with BSC? Does PULSAR delay deterioration in patient-reported outcomes and quality of life compared with BSC? Can adaptive radiotherapy delivered in ultrafractionated pulses improve the therapeutic ratio in patients with HCC and poor liver function? The study will compare PULSAR with BSC to evaluate differences in survival, disease control, liver function, and treatment-related toxicity. Participants randomized to the PULSAR arm will receive 24 Gy of radiation delivered in 3 fractions of 8 Gy each, administered every 3 weeks using adaptive stereotactic radiotherapy. Participants in the BSC arm will receive standard supportive care. All participants will undergo regular assessments of survival, disease progression, liver function, toxicities, and quality of life.
Official title: Personalized Ultrafractionated Stereotactic Adaptive Radiation Therapy for Hepatocellular Carcinoma With Child Pugh B8-9 (PULSAR-HCC): Phase III Randomized Controlled Trial.
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-12-01
Completion Date
2031-12-01
Last Updated
2026-10-26
Healthy Volunteers
No
Conditions
Interventions
Best Supportive Care (BSC)
Palliative Care
Personalized ultrafractionated stereotactic adaptive radiation therapy (PULSAR)
SBRT pulses: 8Gy per pulse every 3 weeks up to 3 pulses
Locations (1)
Princess Margaret Cancer Center
Toronto, Ontario, Canada