Double-Dose chemo strategy shows promise against pancreatic cancer
NCT ID NCT02047474
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a combination of chemotherapy drugs given both before and after surgery for people with early-stage pancreatic cancer. The goal was to shrink the tumor before surgery and kill any remaining cancer cells afterward. 46 participants were enrolled to see if this approach could improve how long they lived without the cancer growing back.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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46 people
The number who actually took part.
- Started
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Mar 2014
- Finished
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Jan 2024
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Pathologic or cytologic documentation of pancreatic adenocarcinoma * Resectable pancreatic adenocarcinoma disease as defined as follows: * No evidence of extrapancreatic disease by cross sectional imaging, PET scan, or laparoscopy, including nodal involvement beyond the peripancreatic tissues and/or distant metastases; * No evidence of tumor extension to superior mesenteric artery, hepatic artery, celiac axis, aorta, or inferior vena cava, and no evidence of occlusion or encasement of the superior mesenteric vein or superior mesenteric vein/portal vein confluence, as assessed by computed tomography (CT) using pancreatic protocol (or magnetic resonance imaging \[MRI\] in patients who cannot undergo CT) and EUS * No prior treatment (chemotherapy, biological therapy, or radiotherapy) for resectable pancreatic cancer * No prior treatment with oxaliplatin, irinotecan (irinotecan hydrochloride), fluorouracil or capecitabine * Patients who received chemotherapy \> 5 years ago for malignancies other than pancreatic cancer are eligible * There is no evidence of the second malignancy at the time of study entry * \> 4 weeks since major surgery * No other concurrent anticancer therapy * Eastern Cooperative Oncology Group (ECOG) performance status: 0-1 * No other malignancy within past five years except basal cell carcinoma of the skin, cervical carcinoma in situ, or non-metastatic prostate cancer * Paraffin block or slides must be available * Adequate organ function * No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung * No \>= grade 2 sensory peripheral neuropathy * No uncontrolled seizure disorder, active neurological disease, or known central nervous system (CNS) disease * No significant cardiac disease, including the following: unstable angina, New York Heart Association class II-IV congestive heart failure, myocardial infarction within six months prior to study enrollment * No history of chronic diarrhea * Not pregnant and not nursing * No other medical condition or reason that, in the opinion of the investigator, would preclude study participation * Absolute neutrophil count \>= 1,500/uL * Platelet count \>= 100,000/uL * Hemoglobin \>= 9 g/dL * Creatinine \< 1.5 X upper limit of normal (ULN) or * Estimated glomerular filtration rate (GFR) \> 30 ml/min * Bilirubin =\< 1.5 X ULN * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 3 X ULN * Negative pregnancy test in women of childbearing age
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Smilow Cancer Hospital at Fairfield
Fairfield, Connecticut, 06824, United States
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Smilow Cancer Hospital at Guilford
Guilford, Connecticut, 06437, United States
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Smilow Cancer Hospital at North Haven
North Haven, Connecticut, 06473, United States
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Smilow Cancer Hospital at Orange
Orange, Connecticut, 06477, United States
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Smilow Cancer Hospital at St. Francis Hospital
Hartford, Connecticut, 06105, United States
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Smilow Cancer Hospital at Torrington
Torrington, Connecticut, 06790, United States
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Smilow Cancer Hospital at Trumbull
Trumbull, Connecticut, 06611, United States
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Smilow Cancer Hospital at Waterbury
Waterbury, Connecticut, 06708, United States
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Yale University
New Haven, Connecticut, 06520-8032, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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