Trial Outcomes & Findings for Combination of SBRT With Sequential S-1 for Treating Locally Advanced Pancreatic Cancer (NCT NCT02704143)
NCT ID: NCT02704143
Last Updated: 2020-10-19
Results Overview
One-year overall survival rate is calculated by the ratio of number of patients surviving more than 1 year to the total number of patients enrolled.
COMPLETED
NA
63 participants
1 year
2020-10-19
Participant Flow
The recruitment period was from February 2016 to March 2018 in Changhai Hospital affiliated to Navy Medical University.
There were significant events that occur after participant enrollment, but prior to assignment of participants to an arm or group.
Participant milestones
| Measure |
Combination of Cyberknife With S-1
Patients with locally advanced pancreatic cancer meeting all inclusion criteria will receive combination of Cyberknife with S-1.
combination of Cyberknife with S-1: Radiation therapy combined with chemotherapy
|
|---|---|
|
Overall Study
STARTED
|
63
|
|
Overall Study
COMPLETED
|
53
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Combination of Cyberknife With S-1
Patients with locally advanced pancreatic cancer meeting all inclusion criteria will receive combination of Cyberknife with S-1.
combination of Cyberknife with S-1: Radiation therapy combined with chemotherapy
|
|---|---|
|
Overall Study
disease progression
|
10
|
Baseline Characteristics
Combination of SBRT With Sequential S-1 for Treating Locally Advanced Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Combination of Cyberknife With S-1
n=63 Participants
Patients with locally advanced pancreatic cancer meeting all inclusion criteria will receive combination of Cyberknife with S-1.
combination of Cyberknife with sequential S-1: Radiation therapy combined with sequential chemotherapy
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
52 Participants
n=5 Participants
|
|
Age, Continuous
|
76.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
63 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
63 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearOne-year overall survival rate is calculated by the ratio of number of patients surviving more than 1 year to the total number of patients enrolled.
Outcome measures
| Measure |
Combination of Cyberknife With S-1
n=63 Participants
Patients with locally advanced pancreatic cancer meeting all inclusion criteria will receive combination of Cyberknife with S-1.
combination of Cyberknife with S-1: Radiation therapy combined with chemotherapy
|
|---|---|
|
One-year Overall Survival Rate
|
46 Participants
|
SECONDARY outcome
Timeframe: Within 90 days after completion of SBRTThe acute toxicities are determined by RTOG Acute Radiation Morbidity Scoring Criteria.
Outcome measures
| Measure |
Combination of Cyberknife With S-1
n=63 Participants
Patients with locally advanced pancreatic cancer meeting all inclusion criteria will receive combination of Cyberknife with S-1.
combination of Cyberknife with S-1: Radiation therapy combined with chemotherapy
|
|---|---|
|
Number of Participants With Acute Toxicities Following SBRT
|
9 Participants
|
SECONDARY outcome
Timeframe: 90 days after SBRTThe late toxicities are determined by RTOG/EORTC Late Radiation Morbidity Scoring Criteria.
Outcome measures
| Measure |
Combination of Cyberknife With S-1
n=63 Participants
Patients with locally advanced pancreatic cancer meeting all inclusion criteria will receive combination of Cyberknife with S-1.
combination of Cyberknife with S-1: Radiation therapy combined with chemotherapy
|
|---|---|
|
Number of Participants With Late Toxicities Following SBRT
|
5 Participants
|
SECONDARY outcome
Timeframe: 3 yearsProgression-free survival is the time from the date of enrollment to the confirmation of disease progression at any sites, including local progression or metastasis, or death from any causes, if this occurred before disease progression. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
Combination of Cyberknife With S-1
n=63 Participants
Patients with locally advanced pancreatic cancer meeting all inclusion criteria will receive combination of Cyberknife with S-1.
combination of Cyberknife with S-1: Radiation therapy combined with chemotherapy
|
|---|---|
|
The Median Progression Free Survival Time Will be Determined.
|
10.1 months
Interval 9.7 to 10.5
|
SECONDARY outcome
Timeframe: 1 yearsPopulation: All domains of QLQ-C30 at 6 months after treatment are reported. Higher scores in function domains and global health status indicate better quality of life, while higher scores in symptom domains imply worse quality of life. The scale range of all following domains is 0-100 (the minimum and maximum score is 0 and 100 points, respectively).
The analysis of quality of life is based on The European Organization for Reasearch and Treatment of Cancer (EORTC): Quality of Life Questionnare-Core 30 (QLQ-C30). Higher scores in function domains and global health status indicate better quality of life, while higher scores in symptom domains imply worse quality of life. The scale range of all domains of QLQ-C30 is 0-100 (the minimum and maximum score is 0 and 100 points, respectively).
Outcome measures
| Measure |
Combination of Cyberknife With S-1
n=63 Participants
Patients with locally advanced pancreatic cancer meeting all inclusion criteria will receive combination of Cyberknife with S-1.
combination of Cyberknife with S-1: Radiation therapy combined with chemotherapy
|
|---|---|
|
The Quality of Life Will be Analyzed.
Global health status
|
50.0 units on a scale
Interval 33.3 to 66.7
|
|
The Quality of Life Will be Analyzed.
Insomnia
|
19.0 units on a scale
Interval 0.0 to 66.7
|
|
The Quality of Life Will be Analyzed.
Physical functioning
|
64.2 units on a scale
Interval 46.7 to 80.0
|
|
The Quality of Life Will be Analyzed.
Role functioning
|
54.8 units on a scale
Interval 16.7 to 83.3
|
|
The Quality of Life Will be Analyzed.
Emotional functioning
|
68.5 units on a scale
Interval 41.7 to 83.3
|
|
The Quality of Life Will be Analyzed.
Cognitive functioning
|
73.8 units on a scale
Interval 33.3 to 83.3
|
|
The Quality of Life Will be Analyzed.
Social functioning
|
74.6 units on a scale
Interval 33.3 to 83.3
|
|
The Quality of Life Will be Analyzed.
Fatigue
|
46.7 units on a scale
Interval 33.3 to 66.7
|
|
The Quality of Life Will be Analyzed.
Nausea and vomiting
|
55.3 units on a scale
Interval 33.3 to 83.3
|
|
The Quality of Life Will be Analyzed.
Pain
|
48.7 units on a scale
Interval 33.3 to 83.3
|
|
The Quality of Life Will be Analyzed.
Dyspnea
|
9.5 units on a scale
Interval 0.0 to 33.3
|
|
The Quality of Life Will be Analyzed.
Appetite loss
|
59.2 units on a scale
Interval 33.3 to 100.0
|
|
The Quality of Life Will be Analyzed.
Constipation
|
13.2 units on a scale
Interval 0.0 to 33.3
|
|
The Quality of Life Will be Analyzed.
Diarrhea
|
13.7 units on a scale
Interval 0.0 to 33.3
|
|
The Quality of Life Will be Analyzed.
Financial difficulties
|
31.2 units on a scale
Interval 0.0 to 66.7
|
SECONDARY outcome
Timeframe: 3 yearsMedian overall survival is calculated by Kaplan-Meier method.
Outcome measures
| Measure |
Combination of Cyberknife With S-1
n=63 Participants
Patients with locally advanced pancreatic cancer meeting all inclusion criteria will receive combination of Cyberknife with S-1.
combination of Cyberknife with S-1: Radiation therapy combined with chemotherapy
|
|---|---|
|
Median Overall Survival Will be Determined.
|
14.4 months
Interval 13.2 to 15.6
|
Adverse Events
Combination of Cyberknife With S-1
Serious adverse events
| Measure |
Combination of Cyberknife With S-1
n=63 participants at risk
Patients with locally advanced pancreatic cancer meeting all inclusion criteria will receive combination of Cyberknife with S-1.
combination of Cyberknife with S-1: Radiation therapy combined with chemotherapy
|
|---|---|
|
Gastrointestinal disorders
nausea and vomitting
|
9.5%
6/63 • Number of events 6 • 1 year
Radiation-induced acute toxicities are adverse effects that occur within 90 days after treatment, and determined by the Radiation Therapy Oncology Group, "Acute radiation morbidity scoring criteria". Late toxicities occurring three months after SBRT are evaluated by the Radiation Therapy Oncology Group/European Organization for Research on the Treatment of Cancer, "Late radiation morbidity scoring schema".
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Huojun Zhang
Changhai Hospital affiliated to Navy Medical University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place