Heptocellular Cancer
Conditions
Brief summary
The proposed study is a single site, prospective, randomized phase 2 study to evaluate the efficacy and tolerability transarterial radioembolization (TARE) versus stereotactic body radiation therapy (SBRT) for hepatocellular carcinoma. The SBRT arm of the trial will involve standard SBRT delivered over 3-5 fractions as tolerated with dose/total therapy adjusted as needed for safety. The TARE arm of the trial will involve a planning arteriogram followed by selective transarterial delivery of Yttrium-90 into the segmental (≤2) artery supplying the tumor. Administered activity will be an amount prescribed to deliver a dose ≥200 Gy to the perfused tissue. The primary endpoint is the rate of re-treatment of the index lesion over 12 months.
Interventions
RADIATIONTransarterial Radioembolization
The TARE arm of the trial will involve a planning arteriogram followed by selective transarterial delivery of Yttrium-90 into the segmental (≤2) artery supplying the tumor. Administered activity will be an amount prescribed to deliver a dose ≥200 Gy to the perfused tissue.
RADIATIONStereotactic Body Radiation Therapy (SBRT)
The SBRT arm of the trial will involve standard SBRT delivered over 3-5 fractions as tolerated with dose/total therapy adjusted as needed for safety.
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Ability to provide written informed consent and HIPAA authorization * Stated willingness to comply with all study procedures and availability for the duration of the study * Male or female, aged ≥ 18 years at time of informed consent * No more than 3 lesions of HCC evaluated to be eligible for TARE or SBRT at multidisciplinary tumor board * Childs-Pugh score ≤ 8 * ECOG performance status ≤2 * Adequate organ function defined as: * serum bilirubin \< 4.0 mg/dL , * albumin \> 2 g/dL
Exclusion criteria
* Any prior SBRT or radioembolization to the target tumor * Macrovascular invasion * Planned or recommended systemic therapy as consolidation * Pregnancy or lactation: Women of childbearing potential must have a negative pregnancy test within 14 days of protocol registration. * Known severe allergic reaction (anaphylaxis) to iodinated contrast Coagulopathy that the provider deems would be unsafe for transarterial therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of re-treatment over 12 months | From enrollment to 12 months following the end of treatment | Rate of re-treatment of the index lesion over 12 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Laboratory toxicities CBC | From enrollment to 24 months post treatment | Laboratory CBC (includes WBC (k/uL), RBC (M/uL), and Platelets (K/uL) |
| Laboratory toxicities CMP | From enrollment to 24 months post treatment | Laboratory CMP (includes Sodium (mmol/L), Creatine (mg/dL), Total Bilirubin (mg/dL), ALP (IU/L), AST/SGOT (IU/L), ALT/SGPT (IU/L), Serum Albumin (g/dl), INR (unitless), AFP (ng/mL) |
| Laboratory toxicities INR | From enrollment to 24 months post treatment | Laboratory INR (unitless) |
| Laboratory toxicities AFP | From enrollment to 24 months post treatment | Laboratory AFP (ng/mL) |
| Clinical toxicities | From enrollment to 24 months post treatment | Clinical toxicities measured using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Scale of 1 to 5 with 5 being the worst outcome. |
| Change in Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) version 4.0 from baseline. Scale of 0 to 4 with 4 being the worst outcome. | From enrollment to 1, 3, and 6 months post treatment | Change in patient reported outcomes |
| Change in COST: A FACIT Measure of Financial Toxicity (FACIT-COST) version 2.0 from baseline. Scale of 0 to 4 with 4 being the worst outcome. | From enrollment to 1, 3, and 6 months post treatment | Change in patient reported outcomes |
| Disease Free Survival | From enrollment to 24 months post treatment | DFS at 2 years |
| Local Control | From enrollment to 6 months post treatment | LC at 6 months after completion of treatment using LIRADS on multiphase CT or MR |
| Overall Survival | From enrollment to 24 months post treatment | OS at 2 years |
Countries
United States
Contacts
CONTACTMarissa Gilbert
PRINCIPAL_INVESTIGATORReena Salgia, MD
Henry Ford Health System
Outcome results
None listed