Trial Outcomes & Findings for Study of Palliative Radiotherapy for Symptomatic Hepatocellular Carcinoma and Liver Metastases (NCT NCT02511522)

NCT ID: NCT02511522

Last Updated: 2024-10-23

Results Overview

• Proportion of patients achieving improvement of liver cancer pain/discomfort by ≥ 2 points in pain "intensity at worst " on Brief Pain Inventory (BPI) from baseline to day 30.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 66 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2024-10-23

Participant Flow

Participant milestones

Measure	Radiotherapy Combined With Best Supportive Care Patients receive a radiation therapy with the use of 8 Gy in one fraction to the whole (or near-whole) liver together with the best supportive care.	Best Supportive Care Alone Patients receive only the best supportive care.
Overall Study STARTED	33	33
Overall Study COMPLETED	33	33
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Radiotherapy Combined With Best Supportive Care n=33 Participants Patients receive a radiation therapy with the use of 8 Gy in one fraction to the whole (or near-whole) liver together with the best supportive care.	Best Supportive Care Alone n=33 Participants Patients receive only the best supportive care.	Total n=66 Participants Total of all reporting groups
Age, Continuous	66 years n=33 Participants	62 years n=33 Participants	65 years n=66 Participants
Sex: Female, Male Female	15 Participants n=33 Participants	14 Participants n=33 Participants	29 Participants n=66 Participants
Sex: Female, Male Male	18 Participants n=33 Participants	19 Participants n=33 Participants	37 Participants n=66 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Canada	33 participants n=33 Participants	33 participants n=33 Participants	66 participants n=66 Participants
ECOG (Eastern Cooperative Oncology Group) Perfromance Status 0	1 Participants n=33 Participants	0 Participants n=33 Participants	1 Participants n=66 Participants
ECOG (Eastern Cooperative Oncology Group) Perfromance Status 1	18 Participants n=33 Participants	8 Participants n=33 Participants	26 Participants n=66 Participants
ECOG (Eastern Cooperative Oncology Group) Perfromance Status 2	7 Participants n=33 Participants	13 Participants n=33 Participants	20 Participants n=66 Participants
ECOG (Eastern Cooperative Oncology Group) Perfromance Status 3	7 Participants n=33 Participants	12 Participants n=33 Participants	19 Participants n=66 Participants

PRIMARY outcome

Timeframe: 30 days

Population: All patients who completed both baseline and day 30 assessments

• Proportion of patients achieving improvement of liver cancer pain/discomfort by ≥ 2 points in pain "intensity at worst " on Brief Pain Inventory (BPI) from baseline to day 30.

Outcome measures

Measure	Radiotherapy Combined With Best Supportive Care n=24 Participants Patients receive a radiation therapy with the use of 8 Gy in one fraction to the whole (or near-whole) liver together with the best supportive care.	Best Supportive Care Alone n=18 Participants Patients receive only the best supportive care.
Proportion of Patients Achieving Significant Improvement of Liver Cancer Pain/Discomfort	16 Participants	4 Participants

SECONDARY outcome

Timeframe: 90 days

Population: All patients randomized

Estimated by Kaplan-Meier method for overall survival defined as time from randomization to death from any cause.

Outcome measures

Measure	Radiotherapy Combined With Best Supportive Care n=33 Participants Patients receive a radiation therapy with the use of 8 Gy in one fraction to the whole (or near-whole) liver together with the best supportive care.	Best Supportive Care Alone n=33 Participants Patients receive only the best supportive care.
Proportion of Patients Alive at Day 90.	51.18 percentage of alive at 90 days Interval 33.12 to 66.63	32.99 percentage of alive at 90 days Interval 17.46 to 49.42

SECONDARY outcome

Timeframe: 30 days

Population: Patients who reported taking opioid medications in the 24 hours prior to their both baseline and day 30 assessments

Outcome measures

Measure	Radiotherapy Combined With Best Supportive Care n=14 Participants Patients receive a radiation therapy with the use of 8 Gy in one fraction to the whole (or near-whole) liver together with the best supportive care.	Best Supportive Care Alone n=14 Participants Patients receive only the best supportive care.
Proportion of Patients Achieving a 25% Reduction in Opioid Use at 30 Days (Employing Daily Morphine Equivalence Scale).	5 Participants	3 Participants

SECONDARY outcome

Timeframe: 30 days

Population: Patients who completed both baseline and day 30 pain/discomfort assessments and reported taking opioid medications in the 24 hours prior to their both baseline and day 30 assessments

Outcome measures

Measure	Radiotherapy Combined With Best Supportive Care n=14 Participants Patients receive a radiation therapy with the use of 8 Gy in one fraction to the whole (or near-whole) liver together with the best supportive care.	Best Supportive Care Alone n=14 Participants Patients receive only the best supportive care.
Proportion of Patients Achieving Improvement of Liver Cancer Pain/Discomfort by ≥ 2 Points in Pain "Intensity at Worst " AND With no Increase in Opioid Use (Employing Daily Morphine Equivalence Scale) on BPI From Baseline to 30 Days.	3 Participants	0 Participants

Adverse Events

Radiotherapy Combined With Best Supportive Care

Serious events: 0 serious events

Other events: 19 other events

Deaths: 19 deaths

Best Supportive Care Alone

Serious events: 0 serious events

Other events: 11 other events

Deaths: 24 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Radiotherapy Combined With Best Supportive Care n=33 participants at risk Patients receive a radiation therapy with the use of 8 Gy in one fraction to the whole (or near-whole) liver together with the best supportive care.	Best Supportive Care Alone n=33 participants at risk Patients receive only the best supportive care.
Gastrointestinal disorders Abdominal pain	33.3% 11/33 • 30 days Only grade 2 or higher adverse events were collected.	15.2% 5/33 • 30 days Only grade 2 or higher adverse events were collected.
Gastrointestinal disorders Constipation	15.2% 5/33 • 30 days Only grade 2 or higher adverse events were collected.	3.0% 1/33 • 30 days Only grade 2 or higher adverse events were collected.
Gastrointestinal disorders Nausea	6.1% 2/33 • 30 days Only grade 2 or higher adverse events were collected.	6.1% 2/33 • 30 days Only grade 2 or higher adverse events were collected.
General disorders Fatigue	15.2% 5/33 • 30 days Only grade 2 or higher adverse events were collected.	18.2% 6/33 • 30 days Only grade 2 or higher adverse events were collected.
General disorders Pain	6.1% 2/33 • 30 days Only grade 2 or higher adverse events were collected.	6.1% 2/33 • 30 days Only grade 2 or higher adverse events were collected.
Metabolism and nutrition disorders Anorexia	12.1% 4/33 • 30 days Only grade 2 or higher adverse events were collected.	3.0% 1/33 • 30 days Only grade 2 or higher adverse events were collected.
Musculoskeletal and connective tissue disorders Back pain	9.1% 3/33 • 30 days Only grade 2 or higher adverse events were collected.	0.00% 0/33 • 30 days Only grade 2 or higher adverse events were collected.
Nervous system disorders Dysgeusia	3.0% 1/33 • 30 days Only grade 2 or higher adverse events were collected.	6.1% 2/33 • 30 days Only grade 2 or higher adverse events were collected.
Psychiatric disorders Insomnia	0.00% 0/33 • 30 days Only grade 2 or higher adverse events were collected.	6.1% 2/33 • 30 days Only grade 2 or higher adverse events were collected.
Respiratory, thoracic and mediastinal disorders Dyspnea	9.1% 3/33 • 30 days Only grade 2 or higher adverse events were collected.	3.0% 1/33 • 30 days Only grade 2 or higher adverse events were collected.

Additional Information

Dr. Chris O'Callaghan

Canadian Cancer Trials Group

Phone: 6135336430

Email: cocallaghan@ctg.queensu.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place