Pancreatic CancerPhase 3NCT03269994
Does Cefoxitin or Piperacillin-Tazobactam Prevent Postoperative Surgical Site Infections After Pancreatoduodenectomy?
A Phase 3 study testing Cefoxitin and Piperacillin-tazobactam in people with Pancreatic Cancer and Pancreas Cancer, run by Memorial Sloan Kettering Cancer Center at 32 sites in 2 countries.
Trial summary
The purpose of this study is to figure out which commonly used antibiotic, cefoxitin or piperacillin-tazobactam, is better at decreasing the rate of surgical site infections after pancreatoduodenectomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatic Cancer, Pancreas Cancer, Pancreatic Diseases
- What is being tested?
- Cefoxitin and Piperacillin-tazobactam
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 967 participants
- Where
- 32 sitesin 2 countries
- Study dates
- 21 Nov 2017to 28 Jan 2025
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >/= 18 years
- Patients undergoing elective pancreatoduodenectomy (PD) for any diagnosis/indication
Who cannot join
- Patients undergoing a minimally invasive PD, such as laparoscopic or robotic PD
- Patients with known and documented allergies to any of the penicillins, cephalosporins, or β-lactamase inhibitors
- Patients who are otherwise ineligible to receive the antibiotics in this study
- Patients highly unlikely to undergo PD according to the surgeon's judgment, such as conditions amenable to pancreas enucleation, ampullectomy, etc.
- Patients with long-term glucocorticosteroid use. The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular)
- Patients unable to provide informed consent
Show all 10Show fewer
- Creatinine clearance (CrCl) </= 40 mL/min
- Patients receiving hemodialysis or peritoneal dialysis
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test
- Patients with a known bacterial infection present at the time of surgery or who received antimicrobial therapy within 7 days prior to surgery
Trial locations and contacts
32 sites in 2 countries.
32 sites in 2 countries
United States29 sites
Emory University School of Medicine
Atlanta, Georgia, 30322
Memorial Sloan Kettering Basking Ridge (Consent only)
Basking Ridge, New Jersey, 07920
Massachusetts General Hospital
Boston, Massachusetts, 02114
Northwestern Medicine (Data Collection)
Chicago, Illinois, 60611
Ohio State University
Columbus, Ohio, 43210
Memorial Sloan Kettering Commack (Consent only)
Commack, New York, 11725
Baylor Scott & White Health
Dallas, Texas, 75246
Duke University
Durham, North Carolina, 27713
NorthShore University Health System
Evanston, Illinois, 60201
Brody School of Medicine at East Carolina University
Greenville, North Carolina, 27834
Hackensack Meridian Health / Hackensack University Medical Center Cancer Center
Hackensack, New Jersey, 07601
Memoral Sloan Kettering Westchester (Consent only)
Harrison, New York, 10604
Pennsylvania State Hershey
Hershey, Pennsylvania, 17033
Indiana University
Indianapolis, Indiana, 46202
University of Iowa
Iowa City, Iowa, 52242
Gundersen Lutheran Medical Foundation
La Crosse, Wisconsin, 54601
University of Wisconsin
Madison, Wisconsin, 53792
Baptist Memorial Healthcare
Memphis, Tennessee, 38120
Intermountain Healthcare
Murray, Utah, 84107
Mount Sinai Hospital
New York, New York, 10029
Mount Sinai West
New York, New York, 10029
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
University of Nebraska Medical Center
Omaha, Nebraska, 68198-7680
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107
Providence Health & Services (Portland Med Ctr)
Portland, Oregon, 97213
UC Davis Comprehensive Cancer Center
Sacramento, California, 95817
University of Utah
Salt Lake City, Utah, 84112
University of Washington School of Medicine
St Louis, Missouri, 63110
Montefiore Health Systems (Montefiore Medical Center)
The Bronx, New York, 10467
Canada3 sites
Hamilton Health Sciences Center (Juravinski Hospital)
Hamilton, Ontario
Ottawa Hospital
Ottawa, Ontario, K1H 8L6
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
About this study
Official title: A Phase III Multicenter, Open Label Randomized Controlled Trial of Cefoxitin Versus Piperacillin-Tazobactam as Surgical Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy
The purpose of this study is to figure out which commonly used antibiotic, cefoxitin or piperacillin-tazobactam, is better at decreasing the rate of surgical site infections after pancreatoduodenectomy.
- Conditions
- Pancreatic Cancer, Pancreas Cancer, Pancreatic Diseases
- Being tested
- Cefoxitin, Piperacillin-tazobactam
- Keywords
- pancreatoduodenectomy, 17-418, cefoxitin, piperacillin-tazobactam
- Medical subject headings
- Pancreatic Neoplasms, Pancreatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CefoxitinDrug
Participants will receive one dose of cefoxitin within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time.
Piperacillin-tazobactamDrug
Participants will receive one dose of piperacillin-tazobactam within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time.
| Study group | Role | What they receive |
|---|---|---|
| Cefoxitin | Active comparator | Not described Receives: Drug: Cefoxitin |
| Piperacillin-tazobactam | Experimental | Not described Receives: Drug: Piperacillin-tazobactam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Evaluated for the Effectiveness of Cefoxitin as a Surgical Antibiotic Prophylaxis.
To compare the effectiveness of cefoxitin, a second generation cephalosporin (Cohort 1), with piperacillin-tazobactam, a broad-spectrum penicillin (Cohort 2), as surgical antibiotic prophylaxis in decreasing the overall rate of postoperative SSIs in patients undergoing PD. The primary endpoint, overall SSI rate, is defined as superficial incisional SSI, deep incisional SSI, or organ/space SSI within the first 30 days after the operation, as defined according to the ACS NSQIP data collection operations manual.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2017
- Study start21 Nov 2017
- Primary completion28 Jan 2025
- Study completion28 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pancreatic CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 967 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Indiana University, Massachusetts General Hospital, Thomas Jefferson University, Washington University School of Medicine, Advocate Illinois Masonic Medical Center, Baptist Memorial Health Care Corporation, Baylor Scott and White Health, The Cleveland Clinic, Emory University, Fox Chase Cancer Center, Gundersen Lutheran Medical Center, Hackensack Meridian Health, Hamilton Health Sciences Center, Intermountain Health Care, Inc., Jersey Shore Medical Center (Hackensack Meridian), Johns Hopkins University, Montefiore Medical Center/Albert Einstein College of Medicine, North Shore University HealthSystem, Milton S. Hershey Medical Center, Rhode Island Hospital, Stony Brook Medicine, Sunnybrook Health Sciences Centre, Temple University, Ohio State University, The Ottowa Hospital/University of Ottowa, University of California, Davis, University of Chicago, University of Iowa, University of Texas Southwestern Medical Center, University of Utah, University of Wisconsin, Madison, Providence Health & Services, Albany Medical College, Northwestern University, Universtiy of Mississippi Medical Center, Mount Sinai Hospital, New York, Brody School of Medicine at East Carolina University
- Responsible party
- Sponsor
- Investigators
- Michael D'Angelica, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03269994
- Sponsor's protocol ID
- 17-418
- Status last verified
- Jan 2025
- First submitted
- 30 Aug 2017
- Last updated
- 21 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
D'Angelica MI, Ellis RJ, Liu JB, Brajcich BC, Gonen M, Thompson VM, Cohen ME, Seo SK, Zabor EC, Babicky ML, Bentrem DJ, Behrman SW, Bertens KA, Celinski SA, Chan CHF, Dillhoff M, Dixon MEB, Fernandez-Del Castillo C, Gholami S, House MG, Karanicolas PJ, Lavu H, Maithel SK, McAuliffe JC, Ott MJ, Reames BN, Sanford DE, Sarpel U, Scaife CL, Serrano PE, Smith T, Snyder RA, Talamonti MS, Weber SM, Yopp AC, Pitt HA, Ko CY. Piperacillin-Tazobactam Compared With Cefoxitin as Antimicrobial Prophylaxis for Pancreatoduodenectomy: A Randomized Clinical Trial. JAMA. 2023 May 9;329(18):1579-1588. doi: 10.1001/jama.2023.5728.
PubMed 37078771Nevarez NM, Brajcich BC, Liu J, Ellis R, Ko CY, Pitt HA, D'Angelica MI, Yopp AC. Cefoxitin versus piperacillin-tazobactam as surgical antibiotic prophylaxis in patients undergoing pancreatoduodenectomy: protocol for a randomised controlled trial. BMJ Open. 2021 Mar 4;11(3):e048398. doi: 10.1136/bmjopen-2020-048398.
PubMed 33664081
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Multicenter, Open Label Randomized Controlled Trial of Cefoxitin Versus Piperacillin-Tazobactam as Surgical Antibiotic Prophylaxis in Patients Undergoing Pancreatoduodenectomy
- ClinicalTrials.gov ID
- NCT03269994
- Acronym / sponsor ID
- 17-418
- Conditions
- Pancreatic Cancer, Pancreas Cancer, Pancreatic Diseases
- Keywords
- pancreatoduodenectomy, 17-418, cefoxitin, piperacillin-tazobactam
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 967 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Indiana University, Massachusetts General Hospital, Thomas Jefferson University, Washington University School of Medicine, Advocate Illinois Masonic Medical Center, Baptist Memorial Health Care Corporation, Baylor Scott and White Health, The Cleveland Clinic, Emory University, Fox Chase Cancer Center, Gundersen Lutheran Medical Center, Hackensack Meridian Health, Hamilton Health Sciences Center, Intermountain Health Care, Inc., Jersey Shore Medical Center (Hackensack Meridian), Johns Hopkins University, Montefiore Medical Center/Albert Einstein College of Medicine, North Shore University HealthSystem, Milton S. Hershey Medical Center, Rhode Island Hospital, Stony Brook Medicine, Sunnybrook Health Sciences Centre, Temple University, Ohio State University, The Ottowa Hospital/University of Ottowa, University of California, Davis, University of Chicago, University of Iowa, University of Texas Southwestern Medical Center, University of Utah, University of Wisconsin, Madison, Providence Health & Services, Albany Medical College, Northwestern University, Universtiy of Mississippi Medical Center, Mount Sinai Hospital, New York, Brody School of Medicine at East Carolina University
- Study start
- 21 Nov 2017 (actual)
- Primary completion
- 28 Jan 2025 (actual)
- Study completion
- 28 Jan 2025 (actual)
- First posted
- 1 Sep 2017 (actual)
- Results
- Posted 21 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to figure out which commonly used antibiotic, cefoxitin or piperacillin-tazobactam, is better at decreasing the rate of surgical site infections after pancreatoduodenectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cefoxitin | Active comparator | Drug: Cefoxitin |
| Piperacillin-tazobactam | Experimental | Drug: Piperacillin-tazobactam |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age >/= 18 years
- Patients undergoing elective pancreatoduodenectomy (PD) for any diagnosis/indication
Key exclusion criteria (10 listed)
- Patients undergoing a minimally invasive PD, such as laparoscopic or robotic PD
- Patients with known and documented allergies to any of the penicillins, cephalosporins, or β-lactamase inhibitors
- Patients who are otherwise ineligible to receive the antibiotics in this study
- Patients highly unlikely to undergo PD according to the surgeon's judgment, such as conditions amenable to pancreas enucleation, ampullectomy, etc.
- Patients with long-term glucocorticosteroid use. The following uses of corticosteroids are permitted: single doses, topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CefoxitinParticipants will receive one dose of cefoxitin within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time. | Drug | Cefoxitin |
| Piperacillin-tazobactamParticipants will receive one dose of piperacillin-tazobactam within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time. | Drug | Piperacillin-tazobactam |
Primary outcome
Number of Participants Evaluated for the Effectiveness of Cefoxitin as a Surgical Antibiotic Prophylaxis.
Time frame: 30 days
To compare the effectiveness of cefoxitin, a second generation cephalosporin (Cohort 1), with piperacillin-tazobactam, a broad-spectrum penicillin (Cohort 2), as surgical antibiotic prophylaxis in decreasing the overall rate of postoperative SSIs in patients undergoing PD. The primary endpoint, overall SSI rate, is defined as superficial incisional SSI, deep incisional SSI, or organ/space SSI within the first 30 days after the operation, as defined according to the ACS NSQIP data collection operations manual.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37078771D'Angelica MI, Ellis RJ, Liu JB, Brajcich BC, Gonen M, Thompson VM, Cohen ME, Seo SK, Zabor EC, Babicky ML, Bentrem DJ, Behrman SW, Bertens KA, Celinski SA, Chan CHF, Dillhoff M, Dixon MEB, Fernandez-Del Castillo C, Gholami S, House MG, Karanicolas PJ, Lavu H, Maithel SK, McAuliffe JC, Ott MJ, Reames BN, Sanford DE, Sarpel U, Scaife CL, Serrano PE, Smith T, Snyder RA, Talamonti MS, Weber SM, Yopp AC, Pitt HA, Ko CY. Piperacillin-Tazobactam Compared With Cefoxitin as Antimicrobial Prophylaxis for Pancreatoduodenectomy: A Randomized Clinical Trial. JAMA. 2023 May 9;329(18):1579-1588. doi: 10.1001/jama.2023.5728.
- Derived from this study: PubMed 33664081Nevarez NM, Brajcich BC, Liu J, Ellis R, Ko CY, Pitt HA, D'Angelica MI, Yopp AC. Cefoxitin versus piperacillin-tazobactam as surgical antibiotic prophylaxis in patients undergoing pancreatoduodenectomy: protocol for a randomised controlled trial. BMJ Open. 2021 Mar 4;11(3):e048398. doi: 10.1136/bmjopen-2020-048398.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
Related trials for Pancreatic Cancer
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
RecruitingPhase 2/3
Multicenter Validation Trial of [18F]AlF-FAPI-74 for PET Imaging of Cancer-associated Fibroblasts Through Fibroblast Activation Protein Inhibitors (FAPI) in Different Tumor Types
Oesophageal Cancer, Gastric Cancer
RecruitingPhase 1
Modified FOLFIRINOX and Pentamidine in Advanced and Metastatic Pancreatic Cancer
Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Atebimetinib + GnP as a First Line Treatment in Patients With Metastatic Pancreatic Adenocarcinoma
Pancreatic Cancer, Pancreatic Cancer Metastatic
RecruitingPhase 3
Lanreotide Versus Placebo Before Surgery to Prevent a Surgical Complication Called a Pancreatic Fistula
Pancreatic Carcinoma, Pancreatic Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael D'Angelica, MD principal investigator
Memorial Sloan Kettering Cancer Center
32 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cefoxitin and Piperacillin-tazobactam in people with Pancreatic Cancer and Pancreas Cancer, run by Memorial Sloan Kettering Cancer Center at 32 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Evaluated for the Effectiveness of Cefoxitin as a Surgical Antibiotic Prophylaxis. (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03269994, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025.