Pancreatic cancer chemo trial pulled before it started
NCT ID NCT05415917
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study was designed to see if giving two chemotherapy drugs (gemcitabine and capecitabine) after surgery could help people with pancreatic cancer stay cancer-free longer. It was for patients who had already received chemotherapy before surgery. However, the trial was withdrawn before enrolling any participants, so no data was collected.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- gemcitabine and capecitabine (chemotherapy)
- What this could lead to
- If successful, this could show that additional chemotherapy after surgery improves disease-free survival for pancreatic cancer patients who already had pre-surgery treatment.
- What could go wrong
- The trial was withdrawn before enrolling anyone, so no results are available. Chemotherapy can cause significant side effects like low blood counts and fatigue.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Started
-
Jul 2022
- Finished
-
Aug 2024
- Lead sponsor
-
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
-
18 years and older
- Sex
-
Anyone
- Healthy volunteers
-
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: * Histologically and/or cytologically confirmed diagnosis of pancreatic ductal adenocarcinoma * Neoadjuvant chemotherapy (for at least three months) ± chemoradiation followed by R0 surgical resection * Eastern Cooperative Oncology Group(ECOG) Performance status of PS 0 - 2 * At least 18 years of age * Adequate bone marrow and organ functions as defined by: * Absolute neutrophil count ≥ 1000 cells/ μL * Hemoglobin ≥ 8 g/ dL * Platelets \> 75,000 / μL * Creatinine ≤ 1.5 x ULN OR creatinine clearance ≥ 30 mL/min by Cockroft-Gault * Total bilirubin ≤1.5 ULN * AST/ ALT \< 2.5 x ULN, unless with liver metastases and then must be \<5 x ULN of normal * Women and men of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect pregnancy on study, she must notify her treating physician immediately * Ability to understand the nature of this study protocol and give written informed consent. * Willingness and ability to comply with scheduled visits, treatment plans laboratory tests and other study procedures Exclusion Criteria: * Receipt of any investigational agents at the time of registration * Known, untreated brain metastases * Presence of metastatic disease or malignant ascites on diagnostic imaging * Grade two or greater peripheral neuropathy * Presence of any additional active malignancy within the past 3 years where the malignancy is at least reasonably likely to later the course of therapy, require systemic therapy or interfere with imaging assessments * Uncontrolled intercurrent illness, including significant active infection, symptomatic congestive heart failure (NYHA classification grade III or IV), unstable angina or active arrhythmia * Major surgery within the 4 weeks prior to initiation of study treatment * A history of allergy or hypersensitivity to any of the study drugs * Any additional significant medical condition, laboratory abnormality, or psychiatric illness that would prevent the subject from fully participating in the study * Pregnancy * Severe hepatic impairment * Participants with known malabsorption
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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
-
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
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Other studies related to the condition(s) this trial covers.
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