Trial Outcomes & Findings for Different Patterns of Target Delineation in SBRT for Locally Advanced Pancreatic Cancer (NCT NCT04699539)
NCT ID: NCT04699539
Last Updated: 2025-12-10
Results Overview
The proportion of patients without disease progression at one year
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
96 participants
Primary outcome timeframe
1 year
Results posted on
2025-12-10
Participant Flow
Participant milestones
| Measure |
Arm A
A conventional-volume SBRT following gemcitabine and nab-paclitaxel
|
Arm B
A recurrence-pattern-based-volume SBRT following gemcitabine and nab-paclitaxel
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
49
|
|
Overall Study
COMPLETED
|
47
|
49
|
|
Overall Study
NOT COMPLETED
|
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 |
Arm A
n=47 Participants
A conventional-volume SBRT following gemcitabine and nab-paclitaxel
|
Arm B
n=49 Participants
A recurrence-pattern-based-volume SBRT following gemcitabine and nab-paclitaxel
|
Total
n=96 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 yerars
n=47 Participants
|
63 yerars
n=49 Participants
|
63.5 years
n=96 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=47 Participants
|
20 Participants
n=49 Participants
|
41 Participants
n=96 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=47 Participants
|
29 Participants
n=49 Participants
|
55 Participants
n=96 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Participants
|
47 Participants
n=47 Participants
|
49 Participants
n=49 Participants
|
96 Participants
n=96 Participants
|
PRIMARY outcome
Timeframe: 1 yearThe proportion of patients without disease progression at one year
Outcome measures
| Measure |
Arm A
n=47 Participants
A conventional-volume SBRT following gemcitabine and nab-paclitaxel
|
Arm B
n=49 Participants
A recurrence-pattern-based-volume SBRT following gemcitabine and nab-paclitaxel
|
|---|---|---|
|
1-year Progression Free Survival Rate
|
9 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: 4 yearsTreatment-related adverse events
Outcome measures
| Measure |
Arm A
n=47 Participants
A conventional-volume SBRT following gemcitabine and nab-paclitaxel
|
Arm B
n=49 Participants
A recurrence-pattern-based-volume SBRT following gemcitabine and nab-paclitaxel
|
|---|---|---|
|
Treatment-related Adverse Events
|
45 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: 4 yearsProgression free survival
Outcome measures
| Measure |
Arm A
n=47 Participants
A conventional-volume SBRT following gemcitabine and nab-paclitaxel
|
Arm B
n=49 Participants
A recurrence-pattern-based-volume SBRT following gemcitabine and nab-paclitaxel
|
|---|---|---|
|
Progression Free Survival
|
7.3 months
Interval 4.5 to 10.1
|
9.6 months
Interval 7.3 to 11.9
|
SECONDARY outcome
Timeframe: 4 yearsOverall Survival
Outcome measures
| Measure |
Arm A
n=47 Participants
A conventional-volume SBRT following gemcitabine and nab-paclitaxel
|
Arm B
n=49 Participants
A recurrence-pattern-based-volume SBRT following gemcitabine and nab-paclitaxel
|
|---|---|---|
|
Overall Survival
|
10.8 months
Interval 9.7 to 11.9
|
15.2 months
Interval 11.6 to 18.8
|
Adverse Events
Arm A
Serious events: 20 serious events
Other events: 43 other events
Deaths: 47 deaths
Arm B
Serious events: 21 serious events
Other events: 42 other events
Deaths: 49 deaths
Serious adverse events
| Measure |
Arm A
n=47 participants at risk
A conventional-volume SBRT following gemcitabine and nab-paclitaxel
|
Arm B
n=49 participants at risk
A recurrence-pattern-based-volume SBRT following gemcitabine and nab-paclitaxel
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
21.3%
10/47 • 4 years
|
16.3%
8/49 • 4 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
25.5%
12/47 • 4 years
|
20.4%
10/49 • 4 years
|
|
Blood and lymphatic system disorders
Anemia
|
6.4%
3/47 • 4 years
|
0.00%
0/49 • 4 years
|
|
Gastrointestinal disorders
Nausea or vomiting
|
12.8%
6/47 • 4 years
|
18.4%
9/49 • 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
4.3%
2/47 • 4 years
|
2.0%
1/49 • 4 years
|
|
Gastrointestinal disorders
Decreased appetite
|
14.9%
7/47 • 4 years
|
22.4%
11/49 • 4 years
|
|
Hepatobiliary disorders
Elevated aspartate aminotransferase
|
17.0%
8/47 • 4 years
|
14.3%
7/49 • 4 years
|
|
Hepatobiliary disorders
Elevated alanine aminotransferase
|
10.6%
5/47 • 4 years
|
12.2%
6/49 • 4 years
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
2.1%
1/47 • 4 years
|
0.00%
0/49 • 4 years
|
|
Metabolism and nutrition disorders
Weight decreased
|
12.8%
6/47 • 4 years
|
14.3%
7/49 • 4 years
|
|
General disorders
Fatigue
|
8.5%
4/47 • 4 years
|
18.4%
9/49 • 4 years
|
Other adverse events
| Measure |
Arm A
n=47 participants at risk
A conventional-volume SBRT following gemcitabine and nab-paclitaxel
|
Arm B
n=49 participants at risk
A recurrence-pattern-based-volume SBRT following gemcitabine and nab-paclitaxel
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
4.3%
2/47 • 4 years
|
2.0%
1/49 • 4 years
|
|
Gastrointestinal disorders
Abdominal pain
|
6.4%
3/47 • 4 years
|
2.0%
1/49 • 4 years
|
|
Hepatobiliary disorders
Elevated aspartate aminotransferase
|
48.9%
23/47 • 4 years
|
53.1%
26/49 • 4 years
|
|
Hepatobiliary disorders
Elevated alanine aminotransferase
|
46.8%
22/47 • 4 years
|
55.1%
27/49 • 4 years
|
|
Hepatobiliary disorders
Blood bilirubin increased
|
8.5%
4/47 • 4 years
|
4.1%
2/49 • 4 years
|
|
Hepatobiliary disorders
Hypoalbuminemia
|
19.1%
9/47 • 4 years
|
10.2%
5/49 • 4 years
|
|
Metabolism and nutrition disorders
Weight decreased
|
51.1%
24/47 • 4 years
|
44.9%
22/49 • 4 years
|
|
General disorders
Fatigue
|
70.2%
33/47 • 4 years
|
75.5%
37/49 • 4 years
|
|
General disorders
Fever
|
14.9%
7/47 • 4 years
|
8.2%
4/49 • 4 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.3%
2/47 • 4 years
|
4.1%
2/49 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.1%
1/47 • 4 years
|
0.00%
0/49 • 4 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.1%
1/47 • 4 years
|
2.0%
1/49 • 4 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
74.5%
35/47 • 4 years
|
67.3%
33/49 • 4 years
|
|
Nervous system disorders
Peripheral neurotoxicity
|
12.8%
6/47 • 4 years
|
6.1%
3/49 • 4 years
|
|
Blood and lymphatic system disorders
Leukopenia
|
76.6%
36/47 • 4 years
|
79.6%
39/49 • 4 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
57.4%
27/47 • 4 years
|
61.2%
30/49 • 4 years
|
|
Blood and lymphatic system disorders
Anemia
|
17.0%
8/47 • 4 years
|
10.2%
5/49 • 4 years
|
|
Gastrointestinal disorders
Nausea or vomiting
|
80.9%
38/47 • 4 years
|
73.5%
36/49 • 4 years
|
|
Gastrointestinal disorders
Diarrhea
|
23.4%
11/47 • 4 years
|
28.6%
14/49 • 4 years
|
|
Gastrointestinal disorders
Decreased appetite
|
83.0%
39/47 • 4 years
|
81.6%
40/49 • 4 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place