Stereotactic Body Proton Radiotherapy for the Treatment of Liver Cancer (NCT04805788) | Clinical Trial Compass
TerminatedPhase 2
Stereotactic Body Proton Radiotherapy for the Treatment of Liver Cancer
Stopped: slow accrual
United States9 participantsStarted 2021-08-24
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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…
What they're measuring
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)