Trial Outcomes & Findings for Y90 Radiation Segmentectomy vs SBRT for HCC (NCT NCT04235660)

Last Updated: 2023-10-25

Results Overview

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.

Recruitment status

TERMINATED

Study phase

Target enrollment

2 participants

Primary outcome timeframe

24 months

Results posted on

2023-10-25

Participant Flow

Participant milestones

Participant milestones
Measure	Yttrium-90 Radiation Segmentectomy 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.	Stereotactic Body Radiation Therapy 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.
Overall Study STARTED	1	1
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Y90 Radiation Segmentectomy vs SBRT for HCC

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Yttrium-90 Radiation Segmentectomy n=1 Participants 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.	Stereotactic Body Radiation Therapy n=1 Participants 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.	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 months

Population: This group consists of all patients who fit inclusion/exclusion criteria and were approached for enrollment in the study

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.

Outcome measures

Outcome measures
Measure	Eligible Participants n=22 Participants This group consists of all patients who fit inclusion/exclusion criteria and were approached for enrollment in the study	Stereotactic Body Radiation Therapy 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) declined to participate	20 Participants	—
Feasibility of Recruitment (Recruitment Rate) recruited	2 Participants	—

SECONDARY outcome

Timeframe: 16 months for the first subject and 4 months for the second

Population: No data were collected for this outcome measure because 0 participants remained enrolled in this time frame

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 months for the first subject and 4 months for the second

Population: 1 pt in y90 arm had 3 month scan to compare to baseline. no other scans

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).

Outcome measures

Outcome measures
Measure	Eligible Participants n=1 Participants This group consists of all patients who fit inclusion/exclusion criteria and were approached for enrollment in the study	Stereotactic Body Radiation Therapy 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.
Mean Change in Hepatobiliary Function	9.1 percentage of liver function decrease	—

SECONDARY outcome

Timeframe: 6 months

Population: for single Y90 pt data was collected. Data not collected for SBRT pt.

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). scale goes from 0-108 with a higher score being better.

Outcome measures

Outcome measures
Measure	Eligible Participants n=1 Participants This group consists of all patients who fit inclusion/exclusion criteria and were approached for enrollment in the study	Stereotactic Body Radiation Therapy 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.
Mean Change in Functional Assessment of Cancer Therapy- General (FACT-G) Score base line score	69 score on a scale	—
Mean Change in Functional Assessment of Cancer Therapy- General (FACT-G) Score 1 month	75 score on a scale	—
Mean Change in Functional Assessment of Cancer Therapy- General (FACT-G) Score 3 month	82 score on a scale	—
Mean Change in Functional Assessment of Cancer Therapy- General (FACT-G) Score 6 month	78 score on a scale	—

SECONDARY outcome

Timeframe: 6 months

Population: data collected for single y90 pt. data not collected for SBRT pt

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). scale is from 0-44 with higher being bettter

Outcome measures

Outcome measures
Measure	Eligible Participants n=1 Participants This group consists of all patients who fit inclusion/exclusion criteria and were approached for enrollment in the study	Stereotactic Body Radiation Therapy 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.
Mean Change in Comprehensive Score for Financial Toxicity baseline	27 score on a scale	—
Mean Change in Comprehensive Score for Financial Toxicity 3 month	23 score on a scale	—
Mean Change in Comprehensive Score for Financial Toxicity 1 month	29 score on a scale	—
Mean Change in Comprehensive Score for Financial Toxicity 6 month	16 score on a scale	—

SECONDARY outcome

Timeframe: 16 months for the first subject and 4 months for the second

Population: No data were collected for this outcome measure because 0 participants remained enrolled in this time frame

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).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 months for the first subject and 4 months for the second

Population: No data were collected for this outcome measure because 0 participants remained enrolled in this time frame

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No data were collected for this outcome measure because 0 participants in the SBRT arm remained enrolled in this time frame and 6 month imaging was unavailable for the pt in the y90 arm

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.

Outcome measures

Outcome data not reported

Adverse Events

Yttrium-90 Radiation Segmentectomy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Stereotactic Body Radiation Therapy

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Paul Haste

Indiana University School of Medicine

Phone: 317-944-5005

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Yttrium-90 Radiation Segmentectomy n=1 participants at risk 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.	Stereotactic Body Radiation Therapy n=1 participants at risk 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.
General disorders fatigue	100.0% 1/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.	100.0% 1/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.
Gastrointestinal disorders nausea	100.0% 1/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.	0.00% 0/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.
Surgical and medical procedures right leg bruise	100.0% 1/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.	0.00% 0/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.
General disorders elevated vitamin D	100.0% 1/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.	0.00% 0/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.
Hepatobiliary disorders elevated AFP	100.0% 1/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.	0.00% 0/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.
Hepatobiliary disorders elevated AST	100.0% 1/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.	0.00% 0/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.
General disorders low serum carbon dioxide	100.0% 1/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.	0.00% 0/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.
General disorders high anion gap	100.0% 1/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.	0.00% 0/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.
Blood and lymphatic system disorders decreased lymphocyte count	100.0% 1/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.	0.00% 0/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.
Blood and lymphatic system disorders decreased platelet count decreased	100.0% 1/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.	0.00% 0/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.
General disorders glucose intolerance	100.0% 1/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.	0.00% 0/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.
General disorders ALT increased	100.0% 1/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.	0.00% 0/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.
General disorders perirectal abscess	100.0% 1/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.	0.00% 0/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) increased size of left renal mass	100.0% 1/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.	0.00% 0/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.
General disorders low sodium	100.0% 1/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.	0.00% 0/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.
Gastrointestinal disorders abdominal pain	0.00% 0/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.	100.0% 1/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.
General disorders low creatinine	0.00% 0/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.	100.0% 1/1 • adverse event data was planned to be collected for up to 24 months. however, total AE data only collected for 15 months from enrollment (at the longest) secondary to pt drop out.