Trial Outcomes & Findings for Standard of Care Chemotherapy With or Without Stereotactic Body Radiation Therapy for Oligometastatic Pancreatic Cancer (NCT NCT04975516)
NCT ID: NCT04975516
Last Updated: 2026-06-18
Results Overview
Disease progression will be determined based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and will be documented at each enrolling site with no central review planned.
TERMINATED
PHASE2
2 participants
Time from randomization to the first of either disease progression or death from any cause, assessed up to 2 years
2026-06-18
Participant Flow
Participant milestones
| Measure |
Group I (SBRT, Chemotherapy)
Patients undergo SBRT QD or every other day for 5 fractions, and receive chemotherapy per standard of care.
Chemotherapy: Given chemotherapy
Stereotactic Body Radiation Therapy: Undergo SBRT
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Biospecimen Collection: Undergo blood collection
Questionnaire Administration: Ancillary studies
|
Group II (Chemotherapy)
Patients receive chemotherapy per standard of care.
Chemotherapy: Given chemotherapy
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Biospecimen Collection: Undergo blood collection
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
1
|
0
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Group I (SBRT, Chemotherapy)
Patients undergo SBRT QD or every other day for 5 fractions, and receive chemotherapy per standard of care.
Chemotherapy: Given chemotherapy
Stereotactic Body Radiation Therapy: Undergo SBRT
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Biospecimen Collection: Undergo blood collection
Questionnaire Administration: Ancillary studies
|
Group II (Chemotherapy)
Patients receive chemotherapy per standard of care.
Chemotherapy: Given chemotherapy
Computed Tomography: Undergo CT
Magnetic Resonance Imaging: Undergo MRI
Biospecimen Collection: Undergo blood collection
Questionnaire Administration: Ancillary studies
|
|---|---|---|
|
Overall Study
Patient withdrawal prior to beginning treatment
|
0
|
1
|
Baseline Characteristics
Standard of Care Chemotherapy With or Without Stereotactic Body Radiation Therapy for Oligometastatic Pancreatic Cancer
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: Time from randomization to the first of either disease progression or death from any cause, assessed up to 2 yearsPopulation: Since only 1 patient received treatment and is included in the analysis population, their outcome information will not be reported to preserve anonymity.
Disease progression will be determined based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria and will be documented at each enrolling site with no central review planned.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Since only 1 patient received treatment and is included in the analysis population, their outcome information will not be reported to preserve anonymity.
A patient will be classified as a confirmed response per the RECIST 1.1 criteria, if they have a partial or complete response for 2 consecutive evaluations at least 4 weeks apart. The proportion of patients with a confirmed response will be calculated and compared between the 2 arms using a Chi-square or Fisher's Exact test.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from study entry to death from any cause, assessed up to 2 yearsPopulation: Since only 1 patient received treatment and is included in the analysis population, their outcome information will not be reported to preserve anonymity.
Will be estimated using the Kaplan-Meier method, where the log-rank test will be used to compare the 2 treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 2 yearsPopulation: Since only 1 patient received treatment and is included in the analysis population, their outcome information will not be reported to preserve anonymity.
The maximum grade for each type of adverse event will be summarized using Common Terminology Criteria for Adverse Events version 5.0. The frequency and percentage of grade 3+ adverse events will be compared between the 2 treatment arms. Comparisons between arms will be made by using either the Chi-square or Fisher's Exact test.
Outcome measures
Outcome data not reported
Adverse Events
Group I (SBRT, Chemotherapy)
Group II (Chemotherapy)
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