Trial Outcomes & Findings for Proton Beam Therapy for Treatment of Hepatocellular Carcinoma (NCT NCT00614913)

NCT ID: NCT00614913

Last Updated: 2012-08-20

Results Overview

Percent of participants alive and without tumor progression 3 years following treatment.

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 76 participants
• Primary outcome timeframe: 3 months
• Results posted on: 2012-08-20

Participant Flow

Patients with a diagnosis of hepatocellular carcinoma were recruited from the hepatology clinic at Loma Linda University Medical Center to participate in this trial.

Patients with documented metastatic disease were excluded from this trial.

Participant milestones

Measure	Proton Beam Therapy Patients received 63Gy in three weeks with proton beam.
Overall Study STARTED	76
Overall Study COMPLETED	76
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Proton Beam Therapy for Treatment of Hepatocellular Carcinoma

Baseline characteristics by cohort

Measure	Proton Beam Therapy n=76 Participants Patients received 63Gy in three weeks with proton beam.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	39 Participants n=5 Participants
Age, Categorical >=65 years	37 Participants n=5 Participants
Age Continuous	62.7 years STANDARD_DEVIATION 5.8 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants
Region of Enrollment United States	76 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Participants that were within the Milan criteria

Percent of participants alive and without tumor progression 3 years following treatment.

Outcome measures

Measure	Proton Beam Therapy n=35 Participants Patients received 63Gy in three weeks with proton beam.
3-year Survival Without Tumor Progression for Patients Within the Milan Criteria	60 percentage of participants

PRIMARY outcome

Timeframe: 3 months

Population: All participants

Median time until disease progression or death

Outcome measures

Measure	Proton Beam Therapy n=76 Participants Patients received 63Gy in three weeks with proton beam.
Median Survival Without Tumor Progression	36 months Interval 16.0 to 56.0

Adverse Events

Proton Beam Therapy

Serious events: 5 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Proton Beam Therapy n=76 participants at risk Patients received 63Gy in three weeks with proton beam.
Gastrointestinal disorders GI Bleeding	6.6% 5/76 • Number of events 5

Other adverse events

Adverse event data not reported

Additional Information

David Bush MD

Radiation Medicine - Loma Linda University Medical Center

Phone: 909-558-4280

Email: dbush@dominion.llumc.edu

Results disclosure agreements

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