18 and older, any sex, with Pancreatic Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression-free Survival (PFS)Primary· 38 months
Progression-free survival (PFS) means the period of time that a participant remains alive without tumor progression either locally or at a distant site in the body (metastasis). The effect of the study treatments was assessed as the median PFS of participants in the treatment groups. The outcome is reported as the median PFS with standard deviation.
Group
Value
95% CI
Modified FOLFIRINOX
6.5
± 6.6
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
8.4
± 9.5
Local Progression-free Survival (Local PFS)Secondary· 38 months
Local progression-free survival (PFS) means the period of time that a participant remains alive without recurrence or advancement of the disease at the baseline sites of the tumor (local progression). The effect of the study treatments was assessed as the median local PFS of participants in the treatment groups. The outcome is reported as the median local PFS with standard deviation.
Group
Value
95% CI
Modified FOLFIRINOX
6.5
± 6.6
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
8.4
± 10.5
Progression-free Survival (PFS) at 1 YearSecondary· 1 year
Progression-free survival (PFS) means the period of time that a participant remains alive without tumor progression either locally or at a distant site in the body (metastasis). The effect of the study treatments was assessed as the number of participants in each treatment group that remained alive without tumor progression, at 1 year after treatment.
The outcome is reported as a number without dispersion.
Group
Value
95% CI
Modified FOLFIRINOX
5
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
Metastasis-free survival (MFS) means the period of time that a participant remains alive without the appearance of new tumor lesions a distant site in the body (metastasis). The effect of the study treatments was assessed as the median MFS of participants in the treatment groups. The outcome is reported as the median PFS with standard deviation.
Group
Value
95% CI
Modified FOLFIRINOX
12.9
± 6.4
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
10.8
± 16.9
Overall Survival (OS)Secondary· 62 months
The effect of the study treatments was assessed as the length of time participants in each treatment group that remained alive. The outcome is reported as the median OS with standard deviation.
Group
Value
95% CI
Modified FOLFIRINOX
12.9
± 6.4
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
13.4
± 16.6
Grade 2 or Greater Gastrointestinal (GI) ToxicitySecondary· 3 months
Toxicity means an adverse event related to the study treatment. Toxicity was assessed between treatment groups as the number of treatment-related , ≥ grade 2 events of gastritis, fistula, enteritis, or ulcer; plus any other Grade 3 to 5 gastrointestinal (GI) toxicity. The outcome is reported as the number of defined adverse events by preferred term for each treatment group, occurring within 3 months of the start of treatment. These adverse events by definition are all within the Common Terminology Criteria for Adverse Events (CTCAE) version 4.01 Gastrointestinal Body System. The outcome is rep
Blood in stool (melena)
Group
Value
95% CI
Modified FOLFIRINOX
1
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
0
Colitis
Group
Value
95% CI
Modified FOLFIRINOX
1
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
0
Colonic obstruction
Group
Value
95% CI
Modified FOLFIRINOX
1
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
0
Diarrhea
Group
Value
95% CI
Modified FOLFIRINOX
3
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
0
Duodenal perforation
Group
Value
95% CI
Modified FOLFIRINOX
0
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
1
Fistula, anal
Group
Value
95% CI
Modified FOLFIRINOX
0
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
3
Fluid in abdomen (ascites)
Group
Value
95% CI
Modified FOLFIRINOX
0
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
2
Gastrointestinal bleed (hemorrhage)
Group
Value
95% CI
Modified FOLFIRINOX
1
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
1
Adverse events — posted to ClinicalTrials.gov
Time frame: up to 62 months.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Modified FOLFIRINOX
Serious: 5/12 (42%)
Deaths: 7/12
Modified FOLFIRINOX Plus Stereotactic Body Radiotherapy
Serious: 7/13 (54%)
Deaths: 8/13
Serious adverse events (10 terms)
Reaction
System
Modified FOLFIRINOX
Modified FOLFIRINOX Plus S…
Bleed (hemorrhage), gastrointestinal upper
Gastrointestinal disorders
—
—
Other, hemoglobin decreased
Blood and lymphatic system disorders
—
—
Pain, abdominal
Gastrointestinal disorders
—
—
Diarrhea
Gastrointestinal disorders
—
—
Bleed (hemorrhage), gastrointestinal
Gastrointestinal disorders
—
—
Nausea
Gastrointestinal disorders
—
—
Pain, intractable (due to disease progression)
General disorders
—
—
Lung infection - Klebsiella pneumonia
Infections and infestations
—
—
Sepsis
Infections and infestations
—
—
Other, renal failure
Renal and urinary disorders
—
—
Other adverse events (163 terms — click to expand)
Reaction
System
Modified FOLFIRINOX
Modified FOLFIRINOX Plus S…
Fatigue
General disorders
—
—
Aspartate aminotransferase increased
Investigations
—
—
Anemia
Blood and lymphatic system disorders
—
—
Diarrhea
Gastrointestinal disorders
—
—
Platelet count decreased
Investigations
—
—
Nausea
Gastrointestinal disorders
—
—
Pain, abdominal
Gastrointestinal disorders
—
—
Alkaline phosphatase increased
Investigations
—
—
Weight loss
Investigations
—
—
Hyperglycemia
Metabolism and nutrition disorders
—
—
Hypoalbuminemia
Metabolism and nutrition disorders
—
—
Lymphocyte count decreased
Investigations
—
—
Decreased appetite (anorexia)
Metabolism and nutrition disorders
—
—
Nerve damage or injury (neuropathy)
Nervous system disorders
—
—
Hypertension
Vascular disorders
—
—
White blood cell (WBC) count elevated (leukocytosis)
The goal of this study is to determine the safety and efficacy of a chemotherapy regimen known as Modified FOLFIRINOX (mFFX) alone or with the addition of Stereotactic Body Radiotherapy (SBRT). We hope to learn if this new treatment combination helps to control the disease and improve survival for patients with locally advanced pancreatic cancer.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
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· not yet recruiting
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· not yet recruiting
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· not yet recruiting
Other recruiting trials for Pancreatic Cancer
Currently open trials in the same condition.
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Stanford University
Last refreshed: 28 October 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01926197.