Trial Outcomes & Findings for Stereotactic Radiotherapy in Locally Advanced Pancreatic Cancer With Different Biological Effective Doses (NCT NCT04603586)
NCT ID: NCT04603586
Last Updated: 2025-10-17
Results Overview
Progression-Free-Survival
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
119 participants
Primary outcome timeframe
3 years
Results posted on
2025-10-17
Participant Flow
Participant milestones
| Measure |
Arm A
SBRT of BED\<70Gy combined with Gemcitabine + albumin-bound paclitaxel
|
Arm B
SBRT of BED \>70Gy combined with Gemcitabine + albumin-bound paclitaxel
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
59
|
|
Overall Study
COMPLETED
|
60
|
59
|
|
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=60 Participants
SBRT of BED\<70Gy combined with Gemcitabine + albumin-bound paclitaxel
|
Arm B
n=59 Participants
SBRT of BED \>70Gy combined with Gemcitabine + albumin-bound paclitaxel
|
Total
n=119 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=60 Participants
|
0 Participants
n=59 Participants
|
0 Participants
n=119 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=60 Participants
|
27 Participants
n=59 Participants
|
54 Participants
n=119 Participants
|
|
Age, Categorical
>=65 years
|
33 Participants
n=60 Participants
|
32 Participants
n=59 Participants
|
65 Participants
n=119 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=60 Participants
|
28 Participants
n=59 Participants
|
55 Participants
n=119 Participants
|
|
Sex: Female, Male
Male
|
33 Participants
n=60 Participants
|
31 Participants
n=59 Participants
|
64 Participants
n=119 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Baseline characteristics
|
60 Participants
n=60 Participants
|
59 Participants
n=59 Participants
|
119 Participants
n=119 Participants
|
PRIMARY outcome
Timeframe: 3 yearsProgression-Free-Survival
Outcome measures
| Measure |
Arm A
n=60 Participants
SBRT of BED\<70Gy combined with Gemcitabine + albumin-bound paclitaxel
|
Arm B
n=59 Participants
SBRT of BED \>70Gy combined with Gemcitabine + albumin-bound paclitaxel
|
|---|---|---|
|
Progression-Free-Survival
|
8.6 month
Interval 7.5 to 9.6
|
11.3 month
Interval 10.1 to 12.5
|
SECONDARY outcome
Timeframe: 3 yearsAdverse events
Outcome measures
| Measure |
Arm A
n=60 Participants
SBRT of BED\<70Gy combined with Gemcitabine + albumin-bound paclitaxel
|
Arm B
n=59 Participants
SBRT of BED \>70Gy combined with Gemcitabine + albumin-bound paclitaxel
|
|---|---|---|
|
Adverse Events
|
58 Participants
|
57 Participants
|
SECONDARY outcome
Timeframe: 3 yearsOverall Survival
Outcome measures
| Measure |
Arm A
n=60 Participants
SBRT of BED\<70Gy combined with Gemcitabine + albumin-bound paclitaxel
|
Arm B
n=59 Participants
SBRT of BED \>70Gy combined with Gemcitabine + albumin-bound paclitaxel
|
|---|---|---|
|
Overall Survival
|
12.2 months
Interval 10.9 to 13.5
|
17.2 months
Interval 15.4 to 19.0
|
Adverse Events
Arm A
Serious events: 26 serious events
Other events: 58 other events
Deaths: 60 deaths
Arm B
Serious events: 25 serious events
Other events: 57 other events
Deaths: 55 deaths
Serious adverse events
| Measure |
Arm A
n=60 participants at risk
SBRT of BED\<70Gy combined with Gemcitabine + albumin-bound paclitaxel
|
Arm B
n=59 participants at risk
SBRT of BED \>70Gy combined with Gemcitabine + albumin-bound paclitaxel
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
18.3%
11/60 • 3 years
|
16.9%
10/59 • 3 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
15.0%
9/60 • 3 years
|
15.3%
9/59 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
3.3%
2/60 • 3 years
|
11.9%
7/59 • 3 years
|
|
Gastrointestinal disorders
Nausea or vomiting
|
13.3%
8/60 • 3 years
|
15.3%
9/59 • 3 years
|
|
General disorders
Fatigue
|
11.7%
7/60 • 3 years
|
13.6%
8/59 • 3 years
|
|
Hepatobiliary disorders
Elevated aspartate aminotransferase
|
13.3%
8/60 • 3 years
|
8.5%
5/59 • 3 years
|
|
Hepatobiliary disorders
Elevated alanine aminotransferase
|
6.7%
4/60 • 3 years
|
13.6%
8/59 • 3 years
|
|
Nervous system disorders
Peripheral neurotoxicity
|
10.0%
6/60 • 3 years
|
11.9%
7/59 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
3/60 • 3 years
|
10.2%
6/59 • 3 years
|
|
Infections and infestations
Fever
|
1.7%
1/60 • 3 years
|
0.00%
0/59 • 3 years
|
|
Hepatobiliary disorders
Blood bilirubin increased
|
0.00%
0/60 • 3 years
|
1.7%
1/59 • 3 years
|
|
Gastrointestinal disorders
Decreased appetite
|
23.3%
14/60 • 3 years
|
16.9%
10/59 • 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
8.3%
5/60 • 3 years
|
6.8%
4/59 • 3 years
|
|
Metabolism and nutrition disorders
Weight decreased
|
18.3%
11/60 • 3 years
|
13.6%
8/59 • 3 years
|
Other adverse events
| Measure |
Arm A
n=60 participants at risk
SBRT of BED\<70Gy combined with Gemcitabine + albumin-bound paclitaxel
|
Arm B
n=59 participants at risk
SBRT of BED \>70Gy combined with Gemcitabine + albumin-bound paclitaxel
|
|---|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
81.7%
49/60 • 3 years
|
84.7%
50/59 • 3 years
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
68.3%
41/60 • 3 years
|
66.1%
39/59 • 3 years
|
|
Blood and lymphatic system disorders
Anemia
|
26.7%
16/60 • 3 years
|
33.9%
20/59 • 3 years
|
|
Gastrointestinal disorders
Nausea or vomiting
|
63.3%
38/60 • 3 years
|
67.8%
40/59 • 3 years
|
|
General disorders
Fatigue
|
85.0%
51/60 • 3 years
|
81.4%
48/59 • 3 years
|
|
Hepatobiliary disorders
Elevated aspartate aminotransferase
|
58.3%
35/60 • 3 years
|
69.5%
41/59 • 3 years
|
|
Hepatobiliary disorders
Elevated alanine aminotransferase
|
61.7%
37/60 • 3 years
|
71.2%
42/59 • 3 years
|
|
Nervous system disorders
Peripheral neurotoxicity
|
18.3%
11/60 • 3 years
|
16.9%
10/59 • 3 years
|
|
Gastrointestinal disorders
Diarrhea
|
21.7%
13/60 • 3 years
|
20.3%
12/59 • 3 years
|
|
Infections and infestations
Fever
|
11.7%
7/60 • 3 years
|
8.5%
5/59 • 3 years
|
|
Hepatobiliary disorders
Blood bilirubin increased
|
5.0%
3/60 • 3 years
|
6.8%
4/59 • 3 years
|
|
Gastrointestinal disorders
Decreased appetite
|
80.0%
48/60 • 3 years
|
86.4%
51/59 • 3 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
28.3%
17/60 • 3 years
|
37.3%
22/59 • 3 years
|
|
Metabolism and nutrition disorders
Weight decreased
|
66.7%
40/60 • 3 years
|
78.0%
46/59 • 3 years
|
|
Gastrointestinal disorders
Constipation
|
6.7%
4/60 • 3 years
|
5.1%
3/59 • 3 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
5/60 • 3 years
|
8.5%
5/59 • 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
6.7%
4/60 • 3 years
|
5.1%
3/59 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.3%
2/60 • 3 years
|
6.8%
4/59 • 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.3%
2/60 • 3 years
|
5.1%
3/59 • 3 years
|
|
General disorders
Alopecia
|
85.0%
51/60 • 3 years
|
89.8%
53/59 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place