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Double-Dose chemo strategy shows promise against pancreatic cancer

NCT ID NCT02047474

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

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.

Participants

46 people

The number who actually took part.

Started

Mar 2014

Finished

Jan 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

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

  • Smilow Cancer Hospital at Fairfield

    Fairfield, Connecticut, 06824, United States

  • Smilow Cancer Hospital at Guilford

    Guilford, Connecticut, 06437, United States

  • Smilow Cancer Hospital at North Haven

    North Haven, Connecticut, 06473, United States

  • Smilow Cancer Hospital at Orange

    Orange, Connecticut, 06477, United States

  • Smilow Cancer Hospital at St. Francis Hospital

    Hartford, Connecticut, 06105, United States

  • Smilow Cancer Hospital at Torrington

    Torrington, Connecticut, 06790, United States

  • Smilow Cancer Hospital at Trumbull

    Trumbull, Connecticut, 06611, United States

  • Smilow Cancer Hospital at Waterbury

    Waterbury, Connecticut, 06708, United States

  • Yale University

    New Haven, Connecticut, 06520-8032, United States

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