Y90 Radiation Segmentectomy vs SBRT for HCC (SBRT vs Y90)
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|ClinicalTrials.gov Identifier: NCT04235660|
Recruitment Status : Recruiting
First Posted : January 22, 2020
Last Update Posted : August 30, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma (HCC)||Radiation: Yttrium-90 Radiation Segmentectomy Radiation: Stereotactic Body Radiation Therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Radiologist assessing response will be blinded to the treatment type|
|Official Title:||Yttrium-90 Radiation Segmentectomy Versus Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Early Stage Hepatocellular Carcinoma (HCC): A Pilot Study|
|Actual Study Start Date :||July 22, 2020|
|Estimated Primary Completion Date :||May 2024|
|Estimated Study Completion Date :||May 2024|
|Active Comparator: Yttrium-90 Radiation Segmentectomy||
Radiation: Yttrium-90 Radiation Segmentectomy
This therapy arm involves two separate steps, a planning/mapping arteriogram and a therapy delivery. The planning arteriogram will be performed to confirm arterial anatomy is acceptable for RS (≤2 segment delivery) and that lung shunting is not too high to preclude treatment with RS. Once confirmed, patients will return for RS (within 45 days of mapping). Dose will be calculated based off the desired treatment volume using pre-treatment cross-sectional imaging. The desired segmental dose will be calculated to be ≥ 200Gy. RS will be performed by one of three separate interventional radiologists with experience in radioembolization. Actual administered activity and location of dose administration will be recorded.
|Active Comparator: Stereotactic Body Radiation Therapy||
Radiation: Stereotactic Body Radiation Therapy
SBRT will be delivered with linear accelerator-based photon beams with either fixed angle non- coplanar fields or dynamic arcs. An internal target volume (ITV) will be generated to account for tumor movement during breathing cycle. Finally, a planning target volume (PTV) will be an expansion of 3- 5mm from the ITV. For Child Pugh A patients, prescription dose will either be 5000cGy in 5 fractions delivered every other day or 4800cGy in 3 fractions delivered twice weekly. For Child Pugh B patients, prescription dose of 4000cGy in 5 fractions delivered every other day. Inverse planning will be used. 95% of the PTV or more will receive at least 100% of the prescription dose. Normal tissue dose constraints for each dose level will be respected with acceptable deviations permitted as outlined in appendix VII. Patients will be seen at least once per week by a clinician to grade toxicities, with on- treatment labs (CBC, CMP, INR) each week.
- Feasibility of Recruitment (Recruitment Rate) [ Time Frame: 24 months ]Feasibility of recruitment will be measured by evaluating the proportion of patients enrolled versus those approached for the study after they have been determined to be a candidate.
- Proportion of patients with any toxicities [ Time Frame: 24 months ]the proportion of patients with any toxicities (≥ grade 4) using CTCAE between RS and SBRT for patients with small (≤3 cm) solitary hepatocellular carcinoma (HCC).
- Mean change in hepatobiliary function [ Time Frame: 24 months ]the mean change in hepatobiliary function, as measured 3 months after treatment using a functional HIDA scan, between RS and SBRT for patients with small (≤3 cm) solitary hepatocellular carcinoma (HCC).
- Mean change in Functional Assessment of Cancer Therapy- General (FACT-G) score [ Time Frame: 6 months ]the mean change in patient-reported outcomes from baseline, at 1, 3 and 6 months, between RS and SBRT, for patients with small (≤3 cm) solitary hepatocellular carcinoma (HCC), using the Functional Assessment of Cancer Therapy- General (FACT-G) and
- Mean change in Comprehensive Score for Financial Toxicity [ Time Frame: 6 months ]the mean change in patient-reported outcomes from baseline, at 1, 3 and 6 months, between RS and SBRT, for patients with small (≤3 cm) solitary hepatocellular carcinoma (HCC), using the Comprehensive Score for Financial Toxicity (COST)
- Disease-free survival (DFS) rates of RS and SBRT [ Time Frame: 24 months ]the disease-free survival (DFS) rates of RS and SBRT at 2 years using mRECIST on CT or MR for patients with small (≤3 cm) solitary hepatocellular carcinoma (HCC).
- Time-to-secondary treatment (TTST) between RS and SBRT [ Time Frame: 24 months ]time-to-secondary treatment (TTST) between RS and SBRT for patients with small (≤3 cm) solitary hepatocellular carcinoma (HCC) up to 2 years after initial treatment.
- Objective response rate [ Time Frame: 6 months ]the objective response rate (ORR) of radiation segmentectomy (RS) and stereotactic body radiation therapy (SBRT) as measured at 6 months using mRECIST (appendix IV) for patients with small (≤3 cm) solitary hepatocellular carcinoma (HCC) to better allow for an appropriately powered trial evaluating the efficacy of these treatments.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04235660
|Contact: Paul Haste, MDfirstname.lastname@example.org|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46202|
|Contact: Hayley Trussell, RN-BSN 317-963-0305 email@example.com|
|Principal Investigator: Paul Haste, MD|