Trial · NCT02562716

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

NCT02562716, Phase 2, Completed, SWOG Cancer Research Network; results first posted 2021-07-23

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 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. Trials, record NCT02562716. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02562716

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: 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 number: NCT02562716
Status: Completed
Phases: Phase 2
Enrollment: 147 participants, actual
Lead sponsor: SWOG Cancer Research Network
Conditions: Pancreatic Adenocarcinoma, Resectable Pancreatic Carcinoma
Interventions: Fluorouracil, Gemcitabine Hydrochloride, Irinotecan Hydrochloride, Oxaliplatin, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Pancreatectomy
First posted: 2015-09-29
Last updated: 2022-10-19
Results first posted: 2021-07-23

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Survival (OS)	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.	OS is the length of time between protocol registration and patient death
Secondary	Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	Duration of treatment and follow up until death or 4 years post registration.	Only adverse events that are possibly, probably or definitely related to preoperative and postoperative chemotherapy are reported.
Secondary	Number of Patients Going to Surgery for Resection After Preoperative Chemotherapy.	Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy).
Secondary	Number of Patients Achieving R0 Resection After Preoperative Chemotherapy.	Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy).	R0 resection classification is defined as macroscopically complete tumor removal with negative microscopic surgical margins (bile duct, pancreatic parenchyma, and superior mesenteric artery margins).
Secondary	Number of Participants With a Response Following Preoperative Chemotherapy, Including Confirmed and Unconfirmed, Complete and Partial Response, Per RECIST 1.1.	Up to 6 months post registration (and within 2 to 4 weeks after the last dose of Cycle 3 preoperative chemotherapy.).	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.
Secondary	Number of Participants With Complete Response, Moderate Response, Minimal Response, and Poor or No Response After Resection.	Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy).	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)
Secondary	Number of Participants With Loco-regional and Distant Recurrence After R0 or R1 Resection.	Up to 4 years	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.
Secondary	Disease-free Survival From the Time of R0 or R1 Resection.	Up to 4 years	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.

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival (OS)	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.	Eligible and analyzable participants.	Months	MEDIAN
SECONDARY	Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	Duration of treatment and follow up until death or 4 years post registration.	Participants who received at least one dose of protocol treatment and were thus eligible for AE assessment.	Participants	NUMBER
SECONDARY	Number of Patients Going to Surgery for Resection After Preoperative Chemotherapy.	Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy).	Eligible and analyzable participants	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Patients Achieving R0 Resection After Preoperative Chemotherapy.	Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy).	Eligible and analyzable participants undergoing surgical resection.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With a Response Following Preoperative Chemotherapy, Including Confirmed and Unconfirmed, Complete and Partial Response, Per RECIST 1.1.	Up to 6 months post registration (and within 2 to 4 weeks after the last dose of Cycle 3 preoperative chemotherapy.).	Eligible and analyzable participants.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Complete Response, Moderate Response, Minimal Response, and Poor or No Response After Resection.	Up to 8 months post registration (and within 4 to 8 weeks after the last dose of Cycle 3 preoperative chemotherapy).	Eligible and analyzable participants undergoing resection.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Loco-regional and Distant Recurrence After R0 or R1 Resection.	Up to 4 years	Eligible and analyzable participants undergoing resection.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Disease-free Survival From the Time of R0 or R1 Resection.	Up to 4 years	Eligible and analyzable participants undergoing surgical resection.	Months	MEDIAN

Source ClinicalTrials.gov

Results by group130

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Overall Survival (OS)	mFOLFIRINOX ->Surg ->mFOLFIRINOX		23.2	95% Confidence Interval 17.6 to 45.9	Months
Overall Survival (OS)	Gem/Nab-P ->Surg ->Gem/Nab-P		23.6	95% Confidence Interval 17.8 to 31.7	Months
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	mFOLFIRINOX->Surg->mFOLFIRINOX	Abdominal infection	1		Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	Gem/Nab-P->Surg->Gem/Nab-P	Abdominal infection	0		Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	mFOLFIRINOX->Surg->mFOLFIRINOX	Acute kidney injury	0		Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	Gem/Nab-P->Surg->Gem/Nab-P	Acute kidney injury	1		Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	mFOLFIRINOX->Surg->mFOLFIRINOX	Alanine aminotransferase increased	3		Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	Gem/Nab-P->Surg->Gem/Nab-P	Alanine aminotransferase increased	2		Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	mFOLFIRINOX->Surg->mFOLFIRINOX	Allergic reaction	1		Participants
Number of Patients With Grade 3 Through Grade 5 Adverse Events That Are Related to Study Drug	Gem/Nab-P->Surg->Gem/Nab-P	Allergic reaction	0		Participants

1 to 10 of 130Source ClinicalTrials.gov

See all 130 results by group

Participant flow8

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	mFOLFIRINOX ->Surg ->mFOLFIRINOX	55
Overall Study	STARTED	Gem/Nab-P ->Surg ->Gem/Nab-P	47
Overall Study	Participants Assessed for AEs	mFOLFIRINOX ->Surg ->mFOLFIRINOX	53
Overall Study	Participants Assessed for AEs	Gem/Nab-P ->Surg ->Gem/Nab-P	45
Overall Study	COMPLETED	mFOLFIRINOX ->Surg ->mFOLFIRINOX	27
Overall Study	COMPLETED	Gem/Nab-P ->Surg ->Gem/Nab-P	19
Overall Study	NOT COMPLETED	mFOLFIRINOX ->Surg ->mFOLFIRINOX	28
Overall Study	NOT COMPLETED	Gem/Nab-P ->Surg ->Gem/Nab-P	28

Source ClinicalTrials.gov

Adverse events444

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Anemia	Blood and lymphatic system disorders	mFOLFIRINOX->Surg->mFOLFIRINOX	32	53
other	Anemia	Blood and lymphatic system disorders	Gem/Nab-P->Surg->Gem/Nab-P	37	45
other	Febrile neutropenia	Blood and lymphatic system disorders	mFOLFIRINOX->Surg->mFOLFIRINOX	0	53
other	Febrile neutropenia	Blood and lymphatic system disorders	Gem/Nab-P->Surg->Gem/Nab-P	2	45
other	Leukocytosis	Blood and lymphatic system disorders	mFOLFIRINOX->Surg->mFOLFIRINOX	1	53
other	Leukocytosis	Blood and lymphatic system disorders	Gem/Nab-P->Surg->Gem/Nab-P	1	45
other	Cardiac arrest	Cardiac disorders	mFOLFIRINOX->Surg->mFOLFIRINOX	0	53
other	Cardiac arrest	Cardiac disorders	Gem/Nab-P->Surg->Gem/Nab-P	1	45
other	Chest pain - cardiac	Cardiac disorders	mFOLFIRINOX->Surg->mFOLFIRINOX	0	53
other	Chest pain - cardiac	Cardiac disorders	Gem/Nab-P->Surg->Gem/Nab-P	1	45

1 to 10 of 444Source ClinicalTrials.gov

See all 444 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	mFOLFIRINOX->Surg->mFOLFIRINOX	32	55
Total, all-cause mortality	Gem/Nab-P->Surg->Gem/Nab-P	32	47
Total, other adverse events	mFOLFIRINOX->Surg->mFOLFIRINOX	53	53
Total, other adverse events	Gem/Nab-P->Surg->Gem/Nab-P	45	45
Total, serious adverse events	mFOLFIRINOX->Surg->mFOLFIRINOX	3	53
Total, serious adverse events	Gem/Nab-P->Surg->Gem/Nab-P	5	45

Source ClinicalTrials.gov

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
32740235	DERIVED	PubMed
33475684	DERIVED	PubMed
38445914	DERIVED	PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
U10CA180888	SWOG Network Group Operations Center of the NCTN	LARA, PRIMO N.; HERSHMAN, DAWN	UNIVERSITY OF CALIFORNIA AT DAVIS	NATIONAL CANCER INSTITUTE	2014 to 2026

Source NIH RePORTER

Trial comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
mFOLFIRINOX ->Surg ->mFOLFIRINOX vs Gem/Nab-P ->Surg ->Gem/Nab-P: Number of Participants With a Response Following Preoperative Chemotherapy, Including Confirmed and Unconfirmed, Complete and Partial Response, Per RECIST 1.1.	Trial comparisons
mFOLFIRINOX ->Surg ->mFOLFIRINOX vs Gem/Nab-P ->Surg ->Gem/Nab-P: Number of Patients Going to Surgery for Resection After Preoperative Chemotherapy.	Trial comparisons
mFOLFIRINOX ->Surg ->mFOLFIRINOX vs Gem/Nab-P ->Surg ->Gem/Nab-P: Number of Patients Achieving R0 Resection After Preoperative Chemotherapy.	Trial comparisons
mFOLFIRINOX->Surg->mFOLFIRINOX vs Gem/Nab-P->Surg->Gem/Nab-P: deaths from any cause	Trial comparisons
mFOLFIRINOX->Surg->mFOLFIRINOX vs Gem/Nab-P->Surg->Gem/Nab-P: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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