A Phase 3 interventional study of Cefoxitin and Piperacillin-tazobactam in Pancreatic Cancer, Pancreas Cancer and Pancreatic Diseases, sponsored by Memorial Sloan Kettering Cancer Center. Completed at 32 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-21.
Sponsored by Memorial Sloan Kettering Cancer Center · Phase 3, Interventional, and Treatment
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.
3,896 studies on the registry are indexed under Pancreatic Neoplasms; 1,007 are open to participants now.
This study's enrollment of 967 is above the median of 47 across 2,932 interventional studies indexed under Pancreatic Neoplasms.
Browse Pancreatic Neoplasms studies →Memorial Sloan Kettering Cancer Center is the lead sponsor of 1,964 studies on the registry; 327 are open to participants now.
Of its 135 completed or terminated interventional studies of FDA-regulated products, 71 (53%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Cefoxitin
Drug: Piperacillin-tazobactam
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.
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.
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.
Time frame: 30 days
| Milestone | Cefoxitin | Piperacillin-tazobactam |
|---|---|---|
| Started | 484 | 483 |
| Completed | 400 | 378 |
| Not completed | 84 | 105 |
| Withdrew: Withdrawal by subject | 4 | 5 |
| Withdrew: Unresectable at surgery | 39 | 58 |
| Withdrew: Patient canceled surgery | 5 | 14 |
| Withdrew: Preoperative progression | 14 | 9 |
| Withdrew: Preoperative infection | 10 | 4 |
| Withdrew: Kidney insufficiency | 1 | 0 |
| Withdrew: Drug allergy | 0 | 2 |
| Withdrew: Operation changed to different resection | 9 | 0 |
| Withdrew: Preoperative steroid | 0 | 3 |
| Withdrew: Accrual closed | 2 | 0 |
| Withdrew: Operation changed to different resection | 0 | 10 |
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.
| Participants | Cefoxitin | Piperacillin-tazobactam |
|---|---|---|
| Number of Participants Evaluated for the Effectiveness of Cefoxitin as a Surgical Antibiotic Prophylaxis. | 400 | 378 |
Collected over 30 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Cefoxitin | 10/400 (2.5%) | 10/400 (2.5%) | 0/400 (0%) |
| Piperacillin-tazobactam | 5/378 (1.3%) | 5/378 (1.3%) | 0/378 (0%) |
| Event | Cefoxitin | Piperacillin-tazobactam |
|---|---|---|
| DeathGeneral disorders | 10/400 | 5/378 |
| Age, Continuous(years) | Cefoxitin | Piperacillin-tazobactam | Total |
|---|---|---|---|
| Median | 68.0 (59.8 to 73.9) | 66.8 (59.6 to 73.8) | 67.0 (59.6 to 73.9) |
| Sex: Female, Male(Participants) | Cefoxitin | Piperacillin-tazobactam | Total |
|---|---|---|---|
| Female | 177 | 145 | 322 |
| Male | 223 | 233 | 456 |
| Ethnicity (NIH/OMB)(Participants) | Cefoxitin | Piperacillin-tazobactam | Total |
|---|---|---|---|
| Hispanic or Latino | 6 | 6 | 12 |
| Not Hispanic or Latino | 307 | 280 | 587 |
| Unknown or Not Reported | 87 | 92 | 179 |
| Race (NIH/OMB)(Participants) | Cefoxitin | Piperacillin-tazobactam | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 1 | 1 |
| Asian | 4 | 8 | 12 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 27 | 19 | 46 |
| White | 276 | 258 | 534 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 93 | 92 | 185 |
| Region of Enrollment(Participants) | Cefoxitin | Piperacillin-tazobactam | Total |
|---|---|---|---|
| United States | 400 | 378 | 778 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Nov 2017 to primary completion in Jan 2025, 86 months.
Results were first posted in Oct 2025, 8 months after primary completion.
Of 46 non-industry phase 3 interventional studies under Pancreatic Neoplasms, half reached primary completion within 68 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 79. This study's 86 months is above that.
Counting every sponsor, half of 84 studies reached it within 58 months; a quarter within 36 and three quarters within 77.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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