Trial Outcomes & Findings for Transarterial Chemoembolization Versus Proton Beam Radiotherapy for the Treatment of Hepatocellular Carcinoma (NCT NCT00857805)

NCT ID: NCT00857805

Last Updated: 2024-05-31

Results Overview

Comparison between arms of the percentage of patient alive 2 years following study treatment.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 76 participants
• Primary outcome timeframe: 24 Months
• Results posted on: 2024-05-31

Participant Flow

Participant milestones

Measure	Transarterial Chemoembolization Transarterial Chemoembolization Transarterial Chemoembolization: Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions.	Proton Beam Radiotherapy Proton Beam Radiotherapy Proton Beam Radiotherapy: Fifteen consecutive sessions
Overall Study STARTED	40	36
Overall Study COMPLETED	39	35
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Transarterial Chemoembolization Transarterial Chemoembolization Transarterial Chemoembolization: Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions.	Proton Beam Radiotherapy Proton Beam Radiotherapy Proton Beam Radiotherapy: Fifteen consecutive sessions
Overall Study Withdrawal by Subject	1	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Transarterial Chemoembolization n=39 Participants Transarterial Chemoembolization Transarterial Chemoembolization: Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions.	Proton Beam Radiotherapy n=35 Participants Proton Beam Radiotherapy Proton Beam Radiotherapy: Fifteen consecutive sessions	Total n=74 Participants Total of all reporting groups
Age, Customized	59.6 years STANDARD_DEVIATION 9.15 • n=39 Participants	61.7 years STANDARD_DEVIATION 8.51 • n=35 Participants	60.65 years STANDARD_DEVIATION 8.83 • n=74 Participants
Sex: Female, Male Female	13 Participants n=39 Participants	8 Participants n=35 Participants	21 Participants n=74 Participants
Sex: Female, Male Male	26 Participants n=39 Participants	27 Participants n=35 Participants	53 Participants n=74 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	39 Participants n=39 Participants	35 Participants n=35 Participants	74 Participants n=74 Participants

PRIMARY outcome

Timeframe: 24 Months

Population: Eligible subjects were adult patients with newly diagnosed and previously untreated HCC. All subjects had characteristic findings of HCC on contrast-enhanced magnetic resonance imaging (MRI) and/or computed tomography (CT) scanning or histologic proof with biopsy. Patients were required to have tumors that were within the Milan or San Francisco criteria, although eligibility for transplant was not required.

Comparison between arms of the percentage of patient alive 2 years following study treatment.

Outcome measures

Measure	Transarterial Chemoembolization n=39 Participants Transarterial Chemoembolization Transarterial Chemoembolization: Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions.	Proton Beam Radiotherapy n=35 Participants Proton Beam Radiotherapy Proton Beam Radiotherapy: Fifteen consecutive sessions
Two Year Overall Survival	65 percentage of participants Interval 52.0 to 83.0	68 percentage of participants Interval 54.0 to 86.0

Adverse Events

Transarterial Chemoembolization

Serious events: 8 serious events

Other events: 39 other events

Deaths: 13 deaths

Proton Beam Radiotherapy

Serious events: 2 serious events

Other events: 35 other events

Deaths: 16 deaths

Serious adverse events

Measure	Transarterial Chemoembolization n=39 participants at risk Transarterial Chemoembolization Transarterial Chemoembolization: Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions.	Proton Beam Radiotherapy n=35 participants at risk Proton Beam Radiotherapy Proton Beam Radiotherapy: Fifteen consecutive sessions
Gastrointestinal disorders Liver Failure	20.5% 8/39 • Number of events 8 • 30 months 74 participants at risk	5.7% 2/35 • Number of events 2 • 30 months 74 participants at risk

Other adverse events

Measure	Transarterial Chemoembolization n=39 participants at risk Transarterial Chemoembolization Transarterial Chemoembolization: Application of carboplatin, doxorubicin in ethiodol into the artery for one or more sessions.	Proton Beam Radiotherapy n=35 participants at risk Proton Beam Radiotherapy Proton Beam Radiotherapy: Fifteen consecutive sessions
Hepatobiliary disorders Abdominal Pain	59.0% 23/39 • 30 months 74 participants at risk	20.0% 7/35 • 30 months 74 participants at risk
Gastrointestinal disorders Nausea	25.6% 10/39 • 30 months 74 participants at risk	25.7% 9/35 • 30 months 74 participants at risk
Gastrointestinal disorders Vomiting	15.4% 6/39 • 30 months 74 participants at risk	0.00% 0/35 • 30 months 74 participants at risk
Gastrointestinal disorders Diarrhea	2.6% 1/39 • 30 months 74 participants at risk	8.6% 3/35 • 30 months 74 participants at risk
Gastrointestinal disorders GI Ulcer	0.00% 0/39 • 30 months 74 participants at risk	2.9% 1/35 • 30 months 74 participants at risk
Gastrointestinal disorders GI Bleed	5.1% 2/39 • 30 months 74 participants at risk	5.7% 2/35 • 30 months 74 participants at risk
Skin and subcutaneous tissue disorders Erythema	0.00% 0/39 • 30 months 74 participants at risk	34.3% 12/35 • 30 months 74 participants at risk
General disorders Fatigue	10.3% 4/39 • 30 months 74 participants at risk	31.4% 11/35 • 30 months 74 participants at risk

Additional Information

David Bush, MD, Professor Radiation Medicine

Loma Linda University Health

Phone: 909 558 1000

Email: DBush@llu.edu

Results disclosure agreements

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