Trial Outcomes & Findings for Stereotactic Body Radiotherapy for Liver Tumors (NCT NCT01347333)
NCT ID: NCT01347333
Last Updated: 2020-03-03
Results Overview
Primary endpoint will be local tumor recurrence rate. Local recurrence is defined as tumor recurrence within the planning target volume.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
23 participants
Primary outcome timeframe
5 years
Results posted on
2020-03-03
Participant Flow
Participant milestones
| Measure |
Liver Metastases
Oligometastases (1-3) with aggregate tumor diameter \< 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes
Stereotactic body radiosurgery: 36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction)
|
Primary Liver Tumors
Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma
Stereotactic Body Radiotherapy: 26-30 Gy / 1 fraction OR 36-45 Gy / 3 fractions (12-15 Gy per fraction) OR 40-50 Gy / 5 fractions (8-10 Gy per fraction)
|
|---|---|---|
|
Overall Study
STARTED
|
23
|
0
|
|
Overall Study
COMPLETED
|
23
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Stereotactic Body Radiotherapy for Liver Tumors
Baseline characteristics by cohort
| Measure |
Liver Metastases
n=23 Participants
Oligometastases (1-3) with aggregate tumor diameter \< 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes
Stereotactic body radiosurgery: 36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction)
|
Primary Liver Tumors
Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma
Stereotactic Body Radiotherapy: 26-30 Gy / 1 fraction OR 36-45 Gy / 3 fractions (12-15 Gy per fraction) OR 40-50 Gy / 5 fractions (8-10 Gy per fraction)
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=99 Participants
|
—
|
15 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=99 Participants
|
—
|
8 Participants
n=206 Participants
|
|
Age, Continuous
|
63 years
n=99 Participants
|
—
|
63 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
—
|
12 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
—
|
11 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
23 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
23 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: No patients enrolled into primary liver tumor group.
Primary endpoint will be local tumor recurrence rate. Local recurrence is defined as tumor recurrence within the planning target volume.
Outcome measures
| Measure |
Liver Metastases
n=23 Participants
Oligometastases (1-3) with aggregate tumor diameter \< 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes
Stereotactic body radiosurgery: 36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction)
|
Primary Liver Tumors
Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma
Stereotactic Body Radiotherapy: 26-30 Gy / 1 fraction OR 36-45 Gy / 3 fractions (12-15 Gy per fraction) OR 40-50 Gy / 5 fractions (8-10 Gy per fraction)
|
|---|---|---|
|
Local Tumor Recurrence Rate
|
4 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: This outcome was not collected.
Toxicities will be assessed using CTCAE grading criteria at specified timepoints.
Outcome measures
Outcome data not reported
Adverse Events
Liver Metastases
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Primary Liver Tumors
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place