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New combo therapy shows promise for tough pancreatic cancers

NCT ID NCT02676349

Disease control Sponsor: Institut de Cancérologie de Lorraine Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Updated 2 times

Summary

This study tested two different treatment plans for people with a specific type of pancreatic cancer that is on the edge of being removable by surgery. 130 patients received either chemotherapy alone or chemotherapy plus radiation before surgery. The goal was to see which approach leads to a better chance of completely removing the tumor and improving outcomes.

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

130 people

The number who actually took part.

Started

Oct 2016

Finished

Dec 2025

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 to 75 years

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: * ECOG performance status 0 or 1 * Adult patients ≥ 18 years and ≤ 75 years of age * Histologic or cytologic proven adenocarcinoma of the pancreas (histologic confirmation of diagnosis is preferred) * Confirmation by independent multidisciplinary expert review of borderline resectable status, according to NCCN-Clinical Practice Guidelines in Oncology "pancreatic adenocarcinoma", version 1.2015. * Adequate hematologic function, as follows: * absolute neutrophil count (ANC) ≥ \> 2000/mm3 * platelet count ≥ 100 000/mm3 * haemoglobin ≥ 10 g/dL * Adequate renal, hepatic and bone marrow function, defined as: * Calculated creatinine clearance ≥ 50 mL/min according to MDRD formula * Serum total bilirubin ≤ 1.5 times the institutional upper limit of normal. Patients with a biliary short metal stent due to cancer obstruction may be included provided that high-quality imaging is performed before stenting and bilirubin level after stent insertion decreased to ≤ 20 mg/L (≤ 34 µmol/l), and there is no cholangitis. * Male and female subjects who agree to use highly effective methods of birth control (e.g., condoms, combined oral contraceptives, some intrauterine devices \[IUDs\], sexual abstinence, or sterilized partner) * for male subject: during the treatment and for up to 6 months after the last dose of oxaliplatin or up to 3 months after the last dose of irinotcan. * for female subject: during the treatment and for up to 4 months after the last dose of oxaliplatin or up to 3 months after the last dose of irinotcan. * Ability to provide written informed consent before the start of any study specific procedures * Patient's legal capacity to consent to study participation and to understand and comply with the requirements of the study. Exclusion Criteria: * Any previous treatment of the pancreatic cancer except biliary short metal stenting (chemotherapy, targeted tumor therapy, local ablative therapy, previous irradiation within the actual fields of planned radiotherapy) * Evidence of distant metastases including ascites * Evidence of extent of pancreatic cancer beyond that defined as "borderline resectable" : suspicious lymphadenopathy outside of the standard field of resection (i.e., aortocaval nodes, distant abdominal nodes) * Contraindication for pancreas resection * Pregnant or breast feeding females * Patients with known Gilbert's Syndrome or homozygosity for UGT1A1\*28 polymorphism * Uracilemia ≥ 16ng/mL either a partial or complete deficiency in dihydropyrimidine dehydrogenase (DPD) * Participation in any other clinical trial or treatment with any experimental drug within 28 days before enrolment to the study or during study participation until the end of treatment visit that can be interfering with the objectives of the study * Previous or concurrent malignant tumor disease other than underlying tumor disease (with the exception of cervical cancer in situ, adequately treated non-melanoma skin cancers, superficial bladder tumors (Ta, Tis, and T1) or any curatively treated without chemotherapy and favourable prognosis tumors without evidence of disease for \> 3 years prior to enrolment) * Any severe and/or uncontrolled medical conditions including but not limited to: * Clinically significant cardiovascular or vascular disease : angina pectoris (even controlled), previous myocardial infarction, serious uncontrolled cardiac arrhythmia, chronic heart failure, acute or chronic infectious disease requiring general treatment) * Acute and chronic, active infectious disorders that requires systemic treatment * Peripheral polyneuropathy \> grade 1 * Any previous inflammatory disease of colon or rectum * Any other severe concomitant disease or disorder, which could influence patient's ability to participate in the study and his/her safety during the study e.g. severe hepatic, renal, pulmonary, metabolic, or psychiatric disorders * Uncorrected disturbed electrolyte balance, in particular hypokalemia or hypocalcemia * Hypersensitivity against any of the study drugs (gemcitabine, oxaliplatin, irinotecan, 5-fluorouracil, folinic acid), or the ingredients of these drugs (e.g. fructose).

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Conditions

The condition(s) this trial relates to.

exocrine pancreatic carcinoma pancreatic adenocarcinoma pancreatic ductal adenocarcinoma pancreatic neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pancreatic carcinoma

Contacts and locations

Locations

  • CHP Saint Grégoire

    Saint-Grégoire, France

  • CHU Reims

    Reims, France

  • Centre Eugène Marquis

    Rennes, France

  • Centre Oscar Lambret

    Lille, France

  • Chru Lille

    Lille, France

  • Chru Nancy

    Vandœuvre-lès-Nancy, France

  • Chru Tours

    Tours, France

  • Chu Colmar

    Colmar, France

  • Chu Nantes

    Nantes, France

  • Chu Rouen

    Rouen, France

  • Hôpital Beaujon

    Clichy, 92110, France

  • Hôpital Cochin (APHP)

    Paris, France

  • Hôpital Européen Marseille

    Marseille, France

  • Hôpital Haut-Lévêque

    Pessac, France

  • Hôpital Henri Mondor (APHP)

    Créteil, France

  • Hôpital La Timone

    Marseille, France

  • Hôpital Paul Brousse

    Villejuif, 94804, France

  • Infirmerie Protestante de Lyon

    Lyon, France

  • Institut Bergonié

    Bordeaux, France

  • Institut Mutualiste Montsouris

    Paris, France

  • Institut Paoli CALMETTES

    Marseille, France

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, France

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, France

  • Institut du Cancer de Montpellier

    Montpellier, France

  • Pitié Salpêtrière (APHP)

    Paris, France

  • Polyclinique Bordeaux Nord

    Bordeaux, France

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