Trial Outcomes & Findings for S1505: Combination Chemotherapy or Gemcitabine Hydrochloride and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery (NCT NCT02562716)

NCT ID: NCT02562716

Last Updated: 2022-10-19

Results Overview

OS is the length of time between protocol registration and patient death

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

147 participants

Primary outcome timeframe

Up to 4 years for the estimates of median overall survival. Up to 2 years for Statistical Analysis 1 and 2, comparing the observed 2-year overall survival (OS) to the null hypothesis of 40%, in each arm.

Results posted on

2022-10-19

Participant Flow

147 participants were randomized, but 43 were found to be ineligible per central radiology review, and 1 was found to be ineligible due to incorrect primary tumor. One patient withdrew study consent prior to any therapy and was not evaluable. Therefore 102 were deemed eligible and analyzable for the primary analysis.

Participant milestones

Participant milestones
Measure	mFOLFIRINOX ->Surg ->mFOLFIRINOX Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity.	Gem/Nab-P ->Surg ->Gem/Nab-P Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.
Overall Study STARTED	55	47
Overall Study Participants Assessed for AEs	53	45
Overall Study COMPLETED	27	19
Overall Study NOT COMPLETED	28	28

Reasons for withdrawal

Reasons for withdrawal
Measure	mFOLFIRINOX ->Surg ->mFOLFIRINOX Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity.	Gem/Nab-P ->Surg ->Gem/Nab-P Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.
Overall Study Adverse Event	7	14
Overall Study Withdrawal unrelated to AE	7	1
Overall Study Progression	8	10
Overall Study Death	2	1
Overall Study Not protocol specified	4	2

Baseline Characteristics

S1505: Combination Chemotherapy or Gemcitabine Hydrochloride and Paclitaxel Albumin-Stabilized Nanoparticle Formulation Before Surgery in Treating Patients With Pancreatic Cancer That Can Be Removed by Surgery

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	mFOLFIRINOX ->Surg ->mFOLFIRINOX n=55 Participants Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity.	Gem/Nab-P ->Surg ->Gem/Nab-P n=47 Participants Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.	Total n=102 Participants Total of all reporting groups
Age, Continuous	66 years n=5 Participants	64 years n=7 Participants	64 years n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	23 Participants n=7 Participants	42 Participants n=5 Participants
Sex: Female, Male Male	36 Participants n=5 Participants	24 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	51 Participants n=5 Participants	43 Participants n=7 Participants	94 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	5 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	52 Participants n=5 Participants	39 Participants n=7 Participants	91 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Zubrod Performance Status 0	34 Participants n=5 Participants	31 Participants n=7 Participants	65 Participants n=5 Participants
Zubrod Performance Status 1	21 Participants n=5 Participants	16 Participants n=7 Participants	37 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 4 years for the estimates of median overall survival. Up to 2 years for Statistical Analysis 1 and 2, comparing the observed 2-year overall survival (OS) to the null hypothesis of 40%, in each arm.

Population: Eligible and analyzable participants.

OS is the length of time between protocol registration and patient death

Outcome measures

Outcome measures
Measure	mFOLFIRINOX ->Surg ->mFOLFIRINOX n=55 Participants Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity.	Gem/Nab-P ->Surg ->Gem/Nab-P n=47 Participants Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.
Overall Survival (OS)	23.2 Months Interval 17.6 to 45.9	23.6 Months Interval 17.8 to 31.7

SECONDARY outcome

Timeframe: Duration of treatment and follow up until death or 4 years post registration.

Population: Participants who received at least one dose of protocol treatment and were thus eligible for AE assessment.

Only adverse events that are possibly, probably or definitely related to preoperative and postoperative chemotherapy are reported.

Outcome measures

Outcome measures
Measure	mFOLFIRINOX ->Surg ->mFOLFIRINOX n=53 Participants Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity.	Gem/Nab-P ->Surg ->Gem/Nab-P n=45 Participants Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Thromboembolic event	2 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Vomiting	2 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Abdominal infection	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Acute kidney injury	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Weight loss	2 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Alanine aminotransferase increased	3 Participants	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Allergic reaction	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Anemia	4 Participants	4 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Anorexia	2 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Aspartate aminotransferase increased	2 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Biliary tract infection	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Blood bilirubin increased	1 Participants	3 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Colonic perforation	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Constipation	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Dehydration	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Diarrhea	8 Participants	3 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Dysesthesia	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Dyspnea	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Fall	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Fatigue	4 Participants	3 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Febrile neutropenia	0 Participants	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hepatobiliary disorders - Other, specify	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hyperglycemia	2 Participants	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hypertension	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hypoalbuminemia	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hypoglycemia	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hypokalemia	3 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hypomagnesemia	0 Participants	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Hyponatremia	2 Participants	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Infections and infestations - Other, specify	1 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Infusion related reaction	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Insomnia	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Leukocytosis	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug White blood cell decreased	1 Participants	6 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Lung infection	1 Participants	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Lymphocyte count decreased	0 Participants	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Mucositis oral	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Myocardial infarction	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Nausea	3 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Neutrophil count decreased	11 Participants	17 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Non-cardiac chest pain	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Pancreatitis	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Papulopustular rash	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Peripheral motor neuropathy	1 Participants	0 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Peripheral sensory neuropathy	5 Participants	3 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Platelet count decreased	3 Participants	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Pneumonitis	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Rectal hemorrhage	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Respiratory failure	0 Participants	1 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Sepsis	1 Participants	2 Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug Skin infection	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy).

Population: Eligible and analyzable participants

Outcome measures

Outcome measures
Measure	mFOLFIRINOX ->Surg ->mFOLFIRINOX n=55 Participants Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity.	Gem/Nab-P ->Surg ->Gem/Nab-P n=47 Participants Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.
Number of Patients Going to Surgery for Resection After Preoperative Chemotherapy.	40 Participants	33 Participants

SECONDARY outcome

Timeframe: Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy).

Population: Eligible and analyzable participants undergoing surgical resection.

R0 resection classification is defined as macroscopically complete tumor removal with negative microscopic surgical margins (bile duct, pancreatic parenchyma, and superior mesenteric artery margins).

Outcome measures

Outcome measures
Measure	mFOLFIRINOX ->Surg ->mFOLFIRINOX n=40 Participants Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity.	Gem/Nab-P ->Surg ->Gem/Nab-P n=33 Participants Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.
Number of Patients Achieving R0 Resection After Preoperative Chemotherapy.	34 Participants	28 Participants

SECONDARY outcome

Timeframe: Up to 6 months post registration (and within 2 to 4 weeks after the last dose of Cycle 3 preoperative chemotherapy.).

Population: Eligible and analyzable participants.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

Outcome measures

Outcome measures
Measure	mFOLFIRINOX ->Surg ->mFOLFIRINOX n=55 Participants Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity.	Gem/Nab-P ->Surg ->Gem/Nab-P n=47 Participants Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.
Number of Participants With a Response Following Preoperative Chemotherapy, Including Confirmed and Unconfirmed, Complete and Partial Response, Per RECIST 1.1.	5 Participants	10 Participants

SECONDARY outcome

Timeframe: Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy).

Population: Eligible and analyzable participants undergoing resection.

Pathologic response was evaluated after the patient had surgery, and was based on local pathology review of the resected surgical specimen, according to the following Tumor Regression Grade definitions: 0: Complete response - no residual tumor 1. Moderate response - minimal residual cancer (single cells or small groups of cancer cells) 2. Minimal response - residual cancer outgrown by fibrosis 3. Poor or no response - no definite response identified (minimal or no tumor kill; extensive residual cancer)

Outcome measures

Outcome measures
Measure	mFOLFIRINOX ->Surg ->mFOLFIRINOX n=40 Participants Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity.	Gem/Nab-P ->Surg ->Gem/Nab-P n=33 Participants Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.
Number of Participants With Complete Response, Moderate Response, Minimal Response, and Poor or No Response After Resection. Complete Response	1 Participants	3 Participants
Number of Participants With Complete Response, Moderate Response, Minimal Response, and Poor or No Response After Resection. Moderate Response	9 Participants	10 Participants
Number of Participants With Complete Response, Moderate Response, Minimal Response, and Poor or No Response After Resection. Minimal Response	12 Participants	10 Participants
Number of Participants With Complete Response, Moderate Response, Minimal Response, and Poor or No Response After Resection. Poor or No Response	18 Participants	10 Participants

SECONDARY outcome

Timeframe: Up to 4 years

Population: Eligible and analyzable participants undergoing resection.

Loco-regional recurrence is defined as any evidence of new disease within the pancreatic tumor bed based on surveillance scans. The pancreatic tumor bed includes: 1. Superior mesenteric artery and vein lymph nodes 2. Lymph nodes in porta hepatis (bile duct, portal vein, hepatic artery lymph nodes) 3. Lymph nodes around left renal vein, inferior vena cava or aorta 4. Celiac axis lymph nodes. Distant Recurrence is defined as any evidence of new disease outside the primary tumor bed (liver, lungs, etc.) based on surveillance scans.

Outcome measures

Outcome measures
Measure	mFOLFIRINOX ->Surg ->mFOLFIRINOX n=40 Participants Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity.	Gem/Nab-P ->Surg ->Gem/Nab-P n=33 Participants Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.
Number of Participants With Loco-regional and Distant Recurrence After R0 or R1 Resection. No Progression	13 Participants	17 Participants
Number of Participants With Loco-regional and Distant Recurrence After R0 or R1 Resection. Loco-regional recurrence	9 Participants	4 Participants
Number of Participants With Loco-regional and Distant Recurrence After R0 or R1 Resection. Distant recurrence	13 Participants	9 Participants
Number of Participants With Loco-regional and Distant Recurrence After R0 or R1 Resection. Both loco-regional and distant recurrence	5 Participants	2 Participants
Number of Participants With Loco-regional and Distant Recurrence After R0 or R1 Resection. Not assessed due to death (cardiac arrest) prior to start of post-op chemo	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 4 years

Population: Eligible and analyzable participants undergoing surgical resection.

Disease-free survival (DFS) is calculated for patients who undergo surgical resection (R0/R1). DFS will be measured from the date of surgical resection to date of first documentation of recurrence (loco-regional or distant) or death due to any cause. Patients last known to be alive and free of disease will be censored at date of last contact.

Outcome measures

Outcome measures
Measure	mFOLFIRINOX ->Surg ->mFOLFIRINOX n=40 Participants Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity.	Gem/Nab-P ->Surg ->Gem/Nab-P n=33 Participants Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity.
Disease-free Survival From the Time of R0 or R1 Resection.	10.9 Months Interval 8.7 to 16.6	14.2 Months Interval 7.3 to 18.6

Adverse Events

mFOLFIRINOX->Surg->mFOLFIRINOX

Serious events: 3 serious events

Other events: 53 other events

Deaths: 32 deaths

Gem/Nab-P->Surg->Gem/Nab-P

Serious events: 5 serious events

Other events: 45 other events

Deaths: 32 deaths

Serious adverse events

Serious adverse events
Measure	mFOLFIRINOX->Surg->mFOLFIRINOX n=53 participants at risk Patients receive oxaliplatin IV over 2 hours and irinotecan hydrochloride IV over 90 minutes on days 1 and 15. Patients also receive 5-fluorouracil IV over 46 hours on days 1-3 and 15-17. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of oxaliplatin, irinotecan hydrochloride, and fluorouracil treatment in the absence of disease progression or unacceptable toxicity. Participants who received at least one dose of protocol treatment and were thus eligible for AE assessment are included in the Serious Adverse Events and Other Adverse Events tables. All eligible participants were assessed for All-Cause Mortality.	Gem/Nab-P->Surg->Gem/Nab-P n=45 participants at risk Patients receive paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes and gemcitabine hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients achieving stable disease or better undergo pancreatectomy 4-8 weeks after completion of first 3 courses of treatment. Within 4-8 weeks following pancreatectomy, patients receive an additional 3 courses of paclitaxel albumin-stabilized nanoparticle formulation and gemcitabine hydrochloride treatment in the absence of disease progression or unacceptable toxicity. Participants who received at least one dose of protocol treatment and were thus eligible for AE assessment are included in the Serious Adverse Events and Other Adverse Events tables. All eligible participants were assessed for All-Cause Mortality.
Cardiac disorders Cardiac arrest	1.9% 1/53 • Duration of treatment and follow up until death or 4 years post registration. Adverse Events (AEs) are reported by CTCAE Version 5.0.	0.00% 0/45 • Duration of treatment and follow up until death or 4 years post registration. Adverse Events (AEs) are reported by CTCAE Version 5.0.
Gastrointestinal disorders Colonic perforation	0.00% 0/53 • Duration of treatment and follow up until death or 4 years post registration. Adverse Events (AEs) are reported by CTCAE Version 5.0.	2.2% 1/45 • Duration of treatment and follow up until death or 4 years post registration. Adverse Events (AEs) are reported by CTCAE Version 5.0.
Hepatobiliary disorders Hepatobiliary disorders-Other	1.9% 1/53 • Duration of treatment and follow up until death or 4 years post registration. Adverse Events (AEs) are reported by CTCAE Version 5.0.	0.00% 0/45 • Duration of treatment and follow up until death or 4 years post registration. Adverse Events (AEs) are reported by CTCAE Version 5.0.
Infections and infestations Lung infection	0.00% 0/53 • Duration of treatment and follow up until death or 4 years post registration. Adverse Events (AEs) are reported by CTCAE Version 5.0.	2.2% 1/45 • Duration of treatment and follow up until death or 4 years post registration. Adverse Events (AEs) are reported by CTCAE Version 5.0.
Infections and infestations Sepsis	1.9% 1/53 • Duration of treatment and follow up until death or 4 years post registration. Adverse Events (AEs) are reported by CTCAE Version 5.0.	2.2% 1/45 • Duration of treatment and follow up until death or 4 years post registration. Adverse Events (AEs) are reported by CTCAE Version 5.0.
Metabolism and nutrition disorders Hypomagnesemia	0.00% 0/53 • Duration of treatment and follow up until death or 4 years post registration. Adverse Events (AEs) are reported by CTCAE Version 5.0.	2.2% 1/45 • Duration of treatment and follow up until death or 4 years post registration. Adverse Events (AEs) are reported by CTCAE Version 5.0.
Respiratory, thoracic and mediastinal disorders Dyspnea	0.00% 0/53 • Duration of treatment and follow up until death or 4 years post registration. Adverse Events (AEs) are reported by CTCAE Version 5.0.	2.2% 1/45 • Duration of treatment and follow up until death or 4 years post registration. Adverse Events (AEs) are reported by CTCAE Version 5.0.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/53 • Duration of treatment and follow up until death or 4 years post registration. Adverse Events (AEs) are reported by CTCAE Version 5.0.	2.2% 1/45 • Duration of treatment and follow up until death or 4 years post registration. Adverse Events (AEs) are reported by CTCAE Version 5.0.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/53 • Duration of treatment and follow up until death or 4 years post registration. Adverse Events (AEs) are reported by CTCAE Version 5.0.	2.2% 1/45 • Duration of treatment and follow up until death or 4 years post registration. Adverse Events (AEs) are reported by CTCAE Version 5.0.

Other adverse events

Additional Information

SWOG Statistician

SWOG Statistics and Data Management Center

Phone: 2066674623

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place