Trial Outcomes & Findings for Combination Chemotherapy Before and After Surgery in Treating Patients With Localized Pancreatic Cancer (NCT NCT02047474)
NCT ID: NCT02047474
Last Updated: 2026-03-06
Results Overview
Evaluated using a one-sided 0.10-alpha level exact test. Summarized using Kaplan-Meier curves
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
46 participants
Primary outcome timeframe
At 12 months
Results posted on
2026-03-06
Participant Flow
Participant milestones
| Measure |
Treatment (mFOLFIRINOX)
NEOADJUVANT THERAPY: Patients receive mFOLFIRINOX comprising oxaliplatin IV over 2 hours, levoleucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV continuously for 46 hours on day 1. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Beginning 3-8 weeks after completion of neoadjuvant therapy patients undergo surgical resection.
ADJUVANT THERARPY: Beginning within 12 weeks after surgery, patients receive mFOLFIRINOX as in neoadjuvant therapy. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
oxaliplatin: Given IV
leucovorin calcium: Given IV
irinotecan hydrochloride: Given IV
fluorouracil: Given IV
therapeutic conventional surgery: Undergo surgical resection
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
STARTED
|
46
|
|
Overall Study
Excluded
|
3
|
|
Overall Study
Completed Preoperative Therapy
|
37
|
|
Overall Study
Underwent Surgical Resection
|
27
|
|
Overall Study
Started Postoperative Chemotherapy
|
22
|
|
Overall Study
Completed Postoperative Chemotherapy
|
19
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
27
|
Reasons for withdrawal
| Measure |
Treatment (mFOLFIRINOX)
NEOADJUVANT THERAPY: Patients receive mFOLFIRINOX comprising oxaliplatin IV over 2 hours, levoleucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV continuously for 46 hours on day 1. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Beginning 3-8 weeks after completion of neoadjuvant therapy patients undergo surgical resection.
ADJUVANT THERARPY: Beginning within 12 weeks after surgery, patients receive mFOLFIRINOX as in neoadjuvant therapy. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
oxaliplatin: Given IV
leucovorin calcium: Given IV
irinotecan hydrochloride: Given IV
fluorouracil: Given IV
therapeutic conventional surgery: Undergo surgical resection
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Study
Physician Decision
|
14
|
|
Overall Study
Withdrawal by Subject
|
13
|
Baseline Characteristics
Combination Chemotherapy Before and After Surgery in Treating Patients With Localized Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Treatment (mFOLFIRINOX)
n=46 Participants
NEOADJUVANT THERAPY: Patients receive mFOLFIRINOX comprising oxaliplatin IV over 2 hours, levoleucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV continuously for 46 hours on day 1. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Beginning 3-8 weeks after completion of neoadjuvant therapy patients undergo surgical resection.
ADJUVANT THERARPY: Beginning within 12 weeks after surgery, patients receive mFOLFIRINOX as in neoadjuvant therapy. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
oxaliplatin: Given IV
leucovorin calcium: Given IV
irinotecan hydrochloride: Given IV
fluorouracil: Given IV
therapeutic conventional surgery: Undergo surgical resection
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Age, Continuous
|
65 years
n=41 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=41 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=41 Participants
|
|
Race (NIH/OMB)
White
|
40 Participants
n=41 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=41 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=41 Participants
|
|
Region of Enrollment
United States
|
46 Participants
n=41 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
0-Fully active, able to carry on all pre-disease performance without restriction
|
36 Participants
n=41 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
1-No physically strenuous activity but ambulatory and can carry out light or sedentary activities
|
10 Participants
n=41 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
2-Capable of selfcare but can't carry out any work activities; up to about 50% of waking hours
|
0 Participants
n=41 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
3-Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
|
0 Participants
n=41 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
4-Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
|
0 Participants
n=41 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) performance status
5-Dead
|
0 Participants
n=41 Participants
|
|
Location of primary tumor
Pancreatic head
|
33 Participants
n=41 Participants
|
|
Location of primary tumor
Pancreatic body/tail
|
13 Participants
n=41 Participants
|
|
Location of primary tumor
Endobiliary stent
|
30 Participants
n=41 Participants
|
|
Histology
Poorly differentiated
|
22 Participants
n=41 Participants
|
|
Histology
Moderately differentiated
|
17 Participants
n=41 Participants
|
|
Histology
Well differentiated
|
0 Participants
n=41 Participants
|
|
Histology
Unknown
|
7 Participants
n=41 Participants
|
|
Baseline Cancer Antigen 19-9 (CA 19-9) concentration
|
131 U/mL
n=41 Participants
|
|
Vascular involvement by tumor
No venous involvement
|
22 Participants
n=41 Participants
|
|
Vascular involvement by tumor
Superior mesenteric vein (SMV) or portal vein (PV) abutment without contour irregularity
|
16 Participants
n=41 Participants
|
|
Vascular involvement by tumor
SMV or (PV) abutment with contour irregularity
|
8 Participants
n=41 Participants
|
|
Genetic Testing
BRCA2 germline mutation
|
1 Participants
n=41 Participants
|
|
Genetic Testing
No germline mutation
|
21 Participants
n=41 Participants
|
|
Genetic Testing
Unavailable
|
24 Participants
n=41 Participants
|
PRIMARY outcome
Timeframe: At 12 monthsEvaluated using a one-sided 0.10-alpha level exact test. Summarized using Kaplan-Meier curves
Outcome measures
| Measure |
Treatment (mFOLFIRINOX)
n=46 Participants
NEOADJUVANT THERAPY: Patients receive mFOLFIRINOX comprising oxaliplatin IV over 2 hours, levoleucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV continuously for 46 hours on day 1. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Beginning 3-8 weeks after completion of neoadjuvant therapy patients undergo surgical resection.
ADJUVANT THERARPY: Beginning within 12 weeks after surgery, patients receive mFOLFIRINOX as in neoadjuvant therapy. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
oxaliplatin: Given IV
leucovorin calcium: Given IV
irinotecan hydrochloride: Given IV
fluorouracil: Given IV
therapeutic conventional surgery: Undergo surgical resection
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Progression Free Survival Rate
|
67 percentage of participants
Interval 56.9 to 100.0
|
SECONDARY outcome
Timeframe: Up to 5 yearsSummarized using Kaplan-Meier curves.
Outcome measures
| Measure |
Treatment (mFOLFIRINOX)
n=46 Participants
NEOADJUVANT THERAPY: Patients receive mFOLFIRINOX comprising oxaliplatin IV over 2 hours, levoleucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV continuously for 46 hours on day 1. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Beginning 3-8 weeks after completion of neoadjuvant therapy patients undergo surgical resection.
ADJUVANT THERARPY: Beginning within 12 weeks after surgery, patients receive mFOLFIRINOX as in neoadjuvant therapy. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
oxaliplatin: Given IV
leucovorin calcium: Given IV
irinotecan hydrochloride: Given IV
fluorouracil: Given IV
therapeutic conventional surgery: Undergo surgical resection
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Overall Survival
|
37.2 months
Interval 17.5 to
insufficient number of participants with events
|
SECONDARY outcome
Timeframe: Up to 5 yearsThe overall response rate (ORR) was assessed as the percentage of participants with a best overall disease response
Outcome measures
| Measure |
Treatment (mFOLFIRINOX)
n=46 Participants
NEOADJUVANT THERAPY: Patients receive mFOLFIRINOX comprising oxaliplatin IV over 2 hours, levoleucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV continuously for 46 hours on day 1. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Beginning 3-8 weeks after completion of neoadjuvant therapy patients undergo surgical resection.
ADJUVANT THERARPY: Beginning within 12 weeks after surgery, patients receive mFOLFIRINOX as in neoadjuvant therapy. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
oxaliplatin: Given IV
leucovorin calcium: Given IV
irinotecan hydrochloride: Given IV
fluorouracil: Given IV
therapeutic conventional surgery: Undergo surgical resection
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Objective Response Rate
|
17 percentage of participants
|
SECONDARY outcome
Timeframe: up to 5 yearsEvaluated using a one-sided 0.10-alpha level exact test. Summarized using Kaplan-Meier curves
Outcome measures
| Measure |
Treatment (mFOLFIRINOX)
n=46 Participants
NEOADJUVANT THERAPY: Patients receive mFOLFIRINOX comprising oxaliplatin IV over 2 hours, levoleucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV continuously for 46 hours on day 1. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Beginning 3-8 weeks after completion of neoadjuvant therapy patients undergo surgical resection.
ADJUVANT THERARPY: Beginning within 12 weeks after surgery, patients receive mFOLFIRINOX as in neoadjuvant therapy. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
oxaliplatin: Given IV
leucovorin calcium: Given IV
irinotecan hydrochloride: Given IV
fluorouracil: Given IV
therapeutic conventional surgery: Undergo surgical resection
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Progression Free Survival Rate
|
16.6 months
Interval 13.3 to 40.6
|
Adverse Events
Treatment (mFOLFIRINOX)
Serious events: 13 serious events
Other events: 46 other events
Deaths: 15 deaths
Serious adverse events
| Measure |
Treatment (mFOLFIRINOX)
n=46 participants at risk
NEOADJUVANT THERAPY: Patients receive mFOLFIRINOX comprising oxaliplatin IV over 2 hours, levoleucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV continuously for 46 hours on day 1. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Beginning 3-8 weeks after completion of neoadjuvant therapy patients undergo surgical resection.
ADJUVANT THERARPY: Beginning within 12 weeks after surgery, patients receive mFOLFIRINOX as in neoadjuvant therapy. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
oxaliplatin: Given IV
leucovorin calcium: Given IV
irinotecan hydrochloride: Given IV
fluorouracil: Given IV
therapeutic conventional surgery: Undergo surgical resection
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Gastrointestinal disorders
vomiting
|
2.2%
1/46 • 5 years
|
|
Gastrointestinal disorders
duodenal perforation
|
2.2%
1/46 • 5 years
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
2.2%
1/46 • 5 years
|
|
Gastrointestinal disorders
abdominal pain
|
4.3%
2/46 • 5 years
|
|
Hepatobiliary disorders
Bile duct stenosis
|
2.2%
1/46 • 5 years
|
|
Infections and infestations
Skin infection
|
4.3%
2/46 • 5 years
|
|
Vascular disorders
Vascular disorders - Other, specify
|
2.2%
1/46 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
2.2%
1/46 • 5 years
|
|
Gastrointestinal disorders
ileus
|
2.2%
1/46 • 5 years
|
|
Gastrointestinal disorders
nausea
|
2.2%
1/46 • 5 years
|
Other adverse events
| Measure |
Treatment (mFOLFIRINOX)
n=46 participants at risk
NEOADJUVANT THERAPY: Patients receive mFOLFIRINOX comprising oxaliplatin IV over 2 hours, levoleucovorin calcium IV over 2 hours, irinotecan hydrochloride IV over 90 minutes, and fluorouracil IV continuously for 46 hours on day 1. Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
SURGERY: Beginning 3-8 weeks after completion of neoadjuvant therapy patients undergo surgical resection.
ADJUVANT THERARPY: Beginning within 12 weeks after surgery, patients receive mFOLFIRINOX as in neoadjuvant therapy. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
oxaliplatin: Given IV
leucovorin calcium: Given IV
irinotecan hydrochloride: Given IV
fluorouracil: Given IV
therapeutic conventional surgery: Undergo surgical resection
laboratory biomarker analysis: Correlative studies
|
|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
10.9%
5/46 • 5 years
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
78.3%
36/46 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.9%
5/46 • 5 years
|
|
Gastrointestinal disorders
Dyspepsia
|
10.9%
5/46 • 5 years
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
10.9%
5/46 • 5 years
|
|
Gastrointestinal disorders
Dry mouth
|
8.7%
4/46 • 5 years
|
|
Nervous system disorders
Dysarthria
|
8.7%
4/46 • 5 years
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
43.5%
20/46 • 5 years
|
|
Investigations
Creatinine increased
|
8.7%
4/46 • 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
8.7%
4/46 • 5 years
|
|
General disorders
Fever
|
8.7%
4/46 • 5 years
|
|
Infections and infestations
Thrush
|
8.7%
4/46 • 5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
6.5%
3/46 • 5 years
|
|
Psychiatric disorders
Depression
|
6.5%
3/46 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
6.5%
3/46 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
6.5%
3/46 • 5 years
|
|
Investigations
Alkaline phosphatase increased
|
58.7%
27/46 • 5 years
|
|
Investigations
Alanine aminotransferase increased
|
45.7%
21/46 • 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
45.7%
21/46 • 5 years
|
|
Investigations
Platelet count decreased
|
45.7%
21/46 • 5 years
|
|
Investigations
Aspartate aminotransferase increased
|
39.1%
18/46 • 5 years
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
21.7%
10/46 • 5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
21.7%
10/46 • 5 years
|
|
Investigations
Neutrophil count decreased
|
17.4%
8/46 • 5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
17.4%
8/46 • 5 years
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
17.4%
8/46 • 5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
17.4%
8/46 • 5 years
|
|
Investigations
White blood cell decrease
|
15.2%
7/46 • 5 years
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
6.5%
3/46 • 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
41.3%
19/46 • 5 years
|
|
Gastrointestinal disorders
Constipation
|
34.8%
16/46 • 5 years
|
|
General disorders
Mucositis
|
32.6%
15/46 • 5 years
|
|
Investigations
Weight loss
|
32.6%
15/46 • 5 years
|
|
Gastrointestinal disorders
Vomiting
|
32.6%
15/46 • 5 years
|
|
Gastrointestinal disorders
Flatulence
|
30.4%
14/46 • 5 years
|
|
Nervous system disorders
Dysgeusia
|
30.4%
14/46 • 5 years
|
|
General disorders
Generalized edema
|
19.6%
9/46 • 5 years
|
|
Psychiatric disorders
Insomnia
|
17.4%
8/46 • 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
17.4%
8/46 • 5 years
|
|
Nervous system disorders
Dizziness
|
15.2%
7/46 • 5 years
|
|
Vascular disorders
Hypertension
|
15.2%
7/46 • 5 years
|
|
Metabolism and nutrition disorders
Hyponatremia
|
13.0%
6/46 • 5 years
|
|
Vascular disorders
Thromboembolic event
|
13.0%
6/46 • 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.0%
6/46 • 5 years
|
|
Nervous system disorders
Headache
|
10.9%
5/46 • 5 years
|
|
Psychiatric disorders
Anxiety
|
10.9%
5/46 • 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
10.9%
5/46 • 5 years
|
|
Gastrointestinal disorders
Nausea
|
58.7%
27/46 • 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
65.2%
30/46 • 5 years
|
|
Nervous system disorders
Paresthesia
|
58.7%
27/46 • 5 years
|
|
Metabolism and nutrition disorders
Anorexia
|
45.7%
21/46 • 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place