Trial Outcomes & Findings for Stereotactic Body Radiotherapy Dose Escalation in Pancreatic Cancer (NCT NCT02454140)
NCT ID: NCT02454140
Last Updated: 2025-09-12
Results Overview
The purpose of this study is to determine the maximum tolerated dose of five fraction stereotactic radiotherapy (SBRT) in pancreatic cancer.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
30 participants
Primary outcome timeframe
From date of randomization to observed dose limiting toxicity (DLT) in 20% of patients assessed up to 3 years
Results posted on
2025-09-12
Participant Flow
Participant milestones
| Measure |
Cohort 1
SBRT 40 Gy in 5 fractions
SBRT: Fixed five-fraction stereotactic radiotherapy
|
Cohort 2
SBRT 45 Gy in 5 fractions (starting dose level)
SBRT: Fixed five-fraction stereotactic radiotherapy
|
Cohort 3
SBRT 50 Gy in 5 fractions
SBRT: Fixed five-fraction stereotactic radiotherapy
|
Cohort 4
SBRT 55 Gy in 5 fractions
SBRT: Fixed five-fraction stereotactic radiotherapy
|
Cohort 5
SBRT 60 Gy in 5 fractions
SBRT: Fixed five-fraction stereotactic radiotherapy
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
3
|
16
|
11
|
0
|
0
|
|
Overall Study
COMPLETED
|
3
|
16
|
11
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
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 |
Cohort 1
n=3 Participants
SBRT 40 Gy in 5 fractions
SBRT: Fixed five-fraction stereotactic radiotherapy
|
Cohort 2
n=16 Participants
SBRT 45 Gy in 5 fractions (starting dose level)
SBRT: Fixed five-fraction stereotactic radiotherapy
|
Cohort 3
n=11 Participants
SBRT 50 Gy in 5 fractions
SBRT: Fixed five-fraction stereotactic radiotherapy
|
Cohort 4
SBRT 55 Gy in 5 fractions
SBRT: Fixed five-fraction stereotactic radiotherapy
|
Cohort 5
SBRT 60 Gy in 5 fractions
SBRT: Fixed five-fraction stereotactic radiotherapy
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
71.3 years
n=3 Participants
|
70.3 years
n=16 Participants
|
77.2 years
n=11 Participants
|
—
|
—
|
72.9 years
n=30 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=3 Participants
|
5 Participants
n=16 Participants
|
5 Participants
n=11 Participants
|
—
|
—
|
12 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=3 Participants
|
11 Participants
n=16 Participants
|
6 Participants
n=11 Participants
|
—
|
—
|
18 Participants
n=30 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants
|
16 participants
n=16 Participants
|
11 participants
n=11 Participants
|
—
|
—
|
30 participants
n=30 Participants
|
PRIMARY outcome
Timeframe: From date of randomization to observed dose limiting toxicity (DLT) in 20% of patients assessed up to 3 yearsPopulation: Patients we're treated at 3 dose levels (40, 45, and 50 Gy). The dose-limiting toxicity for the study was 50 Gy
The purpose of this study is to determine the maximum tolerated dose of five fraction stereotactic radiotherapy (SBRT) in pancreatic cancer.
Outcome measures
| Measure |
All Participants
n=30 Participants
SBRT: Fixed five-fraction stereotactic radiotherapy
|
|---|---|
|
Maximum Tolerated Dose
|
50 Gray
|
Adverse Events
Cohort 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 3 deaths
Cohort 2
Serious events: 2 serious events
Other events: 0 other events
Deaths: 16 deaths
Cohort 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 11 deaths
Cohort 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Cohort 5
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1
n=3 participants at risk
SBRT 40 Gy in 5 fractions
SBRT: Fixed five-fraction stereotactic radiotherapy
|
Cohort 2
n=16 participants at risk
SBRT 45 Gy in 5 fractions (starting dose level)
SBRT: Fixed five-fraction stereotactic radiotherapy
|
Cohort 3
n=11 participants at risk
SBRT 50 Gy in 5 fractions
SBRT: Fixed five-fraction stereotactic radiotherapy
|
Cohort 4
SBRT 55 Gy in 5 fractions
SBRT: Fixed five-fraction stereotactic radiotherapy
|
Cohort 5
SBRT 60 Gy in 5 fractions
SBRT: Fixed five-fraction stereotactic radiotherapy
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Upper gastrointestinal bleed
|
0.00%
0/3 • 6 years
|
6.2%
1/16 • Number of events 1 • 6 years
|
0.00%
0/11 • 6 years
|
—
0/0 • 6 years
|
—
0/0 • 6 years
|
|
Gastrointestinal disorders
Hematemesis
|
0.00%
0/3 • 6 years
|
6.2%
1/16 • Number of events 1 • 6 years
|
0.00%
0/11 • 6 years
|
—
0/0 • 6 years
|
—
0/0 • 6 years
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. James D. Murphy
University of California, San Diego
Phone: (858) 822-6040
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place