Trial Outcomes & Findings for Stereotactic Radiation Therapy in Treating Patients With Liver Metastases (NCT NCT00938457)

Results Overview

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

3 participants

Primary outcome timeframe

2 months

Results posted on

2016-05-19

Participant Flow

Three patients were recruited at Mayo Clinic between January 2010 and May 2010.

This was a phase I/II trial. A total of 3 participants were accrued, all to the phase I portion. This trial was terminated due to poor accrual. No patients were accrued to the phase II portion. No results from the phase II portion are available.

Participant milestones

Participant milestones
Measure	Arm I Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Stereotactic Radiation Therapy in Treating Patients With Liver Metastases

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm I n=3 Participants Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
Age, Continuous	60 years n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 months

Population: Not enough patients were accrued to the Phase I portion to determine the MTD.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: At 1 year

Population: No patients were accrued to the Phase II portion.

LC is defined as no evidence of disease progression within the volume treated to prescription dose (i.e. PTV) for a specific lesion. The development of new intrahepatic metastases sites outside of the PTV will not be considered local failures.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Number of patients with a grade \>= 3 adverse event. Adverse events were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 3. Description of Grades: Grade 1: Mild Grade 2: Moderate Grade 3: Severe Grade 4: Life-threatening Grade 5: Death

Outcome measures

Outcome measures
Measure	Arm I n=3 Participants Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
Toxicity and Adverse Events Profile (Phase I)	0 participants

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Arm I n=3 participants at risk Patients undergo either percutaneous placement of metallic fiducial markers within the liver or respiratory-correlated cone-beam computed tomography for stereotactic targeting and planning. Patients then undergo single-fraction stereotactic body radiotherapy over approximately 1 hour within 1 week of the marker placement.
Cardiac disorders Pericarditis	33.3% 1/3 • Number of events 1
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 1
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1
Investigations Alanine aminotransferase increased	33.3% 1/3 • Number of events 1
Investigations Bilirubin	33.3% 1/3 • Number of events 2

Additional Information

Dr. Robert C. Miller

Mayo Clinic

Phone: 507-284-2669

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place