Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not yet recruitingRare disease

Randomized trial of irinotecan drug combination versus standard therapy as first-line treatment in patients with locally advanced or metastatic small bowel adenocarcinoma

Verified siteRegistered drug
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial focuses on adults with locally advanced or metastatic small bowel adenocarcinoma, a rare cancer that has spread beyond the small intestine. Two chemotherapy approaches are being compared: a three‑drug regimen known as mFOLFIRINOX, which contains irinotecan, oxaliplatin, and fluorouracil together with calcium folinate to protect normal cells, and a two‑drug regimen called FOLFOX, which includes oxaliplatin and fluorouracil with calcium folinate.

The purpose of the study is to determine which of the two regimens works better as the first treatment given for this cancer. Participants will be randomly assigned to receive either the three‑drug or the two‑drug combination, with treatment given through an IV infusion every two weeks for several cycles, followed by regular check‑ups.

During the study, imaging scans will be performed to see if the tumor grows or shrinks, allowing calculation of measures such as progression‑free survival (the time a patient lives without the disease getting worse) and overall survival (the time a patient lives after starting treatment). The rate of tumor shrinkage, called objective response rate, and the depth of response will also be recorded. Patients will complete a short questionnaire about quality of life, and any side effects will be closely monitored and graded for seriousness.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and treatment assignment

    After enrollment you are randomly assigned to receive either the modified folfirinox regimen or the folfox regimen. this assignment determines which combination of medicines you will receive during the trial.

  2. Step 2

    Baseline assessments

    Before the first dose, imaging studies (such as CT scans) are performed to document the current size and location of the cancer.

    Blood samples are taken to evaluate organ function and to calculate the correct dosage of each medication based on your body surface area.

  3. Step 3

    First treatment cycle – medication administration

    On the first day of the cycle you receive a series of infusions and an injection according to the study protocol.

    The infusion includes oxaliplatin at a dose of 85 mg per square meter of body surface area, irinotecan at a dose of 150 mg per square meter, and calcium folinate at a dose of 400 mg per square meter.

    Following the infusions, an injection of fluorouracil is given at a dose of 2400 mg per square meter.

  4. Step 4

    Subsequent treatment cycles

    The same set of medicines (oxaliplatin, irinotecan, calcium folinate, and fluorouracil) is given in each additional cycle, using the same dosages based on your body surface area.

    Each cycle follows the same administration pattern as the first cycle, as defined by the trial schedule.

  5. Step 5

    Regular monitoring

    Periodic blood tests are performed to monitor organ function and detect any side effects.

    Imaging studies are repeated at scheduled intervals to assess whether the cancer is responding to treatment.

    Any side effects are evaluated and may lead to dose adjustments or temporary interruptions, according to the study guidelines.

  6. Step 6

    Treatment discontinuation and follow‑up

    Treatment is stopped if the disease progresses, if unacceptable side effects occur, or after the predetermined number of cycles is completed.

    After stopping the study medication, you continue with regular follow‑up visits to monitor overall survival and quality of life.

Who can join the trial?

12 criteria

  • Give a signed informed consent indicating you agree to join the study.
  • If you are not taking blood‑thinning medication, your blood clotting tests (INR and PTT) must be less than 1.5 times the normal upper limit; people who are on approved blood thinners are also allowed.
  • You must be able to process the chemotherapy drug fluorouracil normally. This means you have either taken similar drugs before without serious side effects, or you have had a normal test for the enzyme DPD that breaks down the drug. If a DPD test shows a mild deficiency, the dose will be reduced by half.
  • Women who could become pregnant must have a negative pregnancy test within 14 days before starting the study and must agree to avoid pregnancy by either staying abstinent or using highly effective birth control (failure rate less than 1 % per year) during treatment and for six months after the last dose. Men with partners who could become pregnant must also use condoms plus another highly effective method, stay abstinent, or both, and must not donate sperm during this time.
  • You must be at least 18 years old when you sign the consent form.
  • Your diagnosis must be confirmed by a tissue test showing small bowel adenocarcinoma.
  • Your tumor must be microsatellite stable or have normal mismatch repair function, as shown by standard lab tests.
  • Your cancer must be judged by the study doctors as either locally advanced and not removable by surgery, or it must have spread (metastasized) to other parts of the body.
  • You must not have received any cancer‑directed treatment for this advanced or metastatic disease before joining the trial.
  • You need to have at least one tumor measurement that can be evaluated using the standard criteria called RECIST 1.1.
  • Your overall health level, measured by the ECOG performance status, must be 0‑2 (able to care for yourself). If you are older than 70, the status must be 0 or 1.
  • Your blood, liver and kidney function must be adequate, shown by lab results that meet the following limits: absolute neutrophil count ≥ 1.5 × 10⁹/L (1500/µL), hemoglobin ≥ 80 g/L (8 g/dL) with or without transfusion, platelet count ≥ 100 × 10⁹/L (100,000/µL) without transfusion, total bilirubin ≤ 1.5 × upper limit of normal, AST and ALT ≤ 2.5 × upper limit of normal (or ≤ 5 × if due to liver metastasis), and estimated kidney filtration rate ≥ 50 mL/min or serum creatinine ≤ 1.5 × upper limit of normal.

Who cannot join the trial?

25 criteria

  • Having cancer of the ampulla of Vater (the small opening where bile and pancreatic fluids enter the intestine).
  • Having severe long‑lasting wounds that do not heal, open sores (ulcerous lesions), or a broken bone that has not been treated.
  • Being known to be allergic (hypersensitive) to any of the chemotherapy medicines 5‑FU, leucovorin, capecitabine, irinotecan, oxaliplatin, or to any of the other ingredients in the drug.
  • Having taken or currently taking the antiviral drug brivudine.
  • Having nerve damage in the hands or feet (peripheral neuropathy) that causes functional problems worse than a mild level (greater than grade 1 on the CTCAE grading system).
  • Using Johannis herbs (herbal preparations) at the same time as the study drugs.
  • Having pernicious anemia or another type of large‑cell anemia caused by a lack of vitamin B12.
  • Having had major surgery, an open tissue biopsy, or a serious injury within the past 21 days that could interfere with the study treatment.
  • Having any other disease, metabolic problem, physical‑exam finding, or lab result that makes the study drug unsafe, could affect the study results, or puts the patient at high risk of complications.
  • Having a history of another cancer, unless the other cancer: (a) has been absent for at least three years, (b) was a basal cell or squamous cell skin cancer, in‑situ cervical, breast, prostate, or stage I uterine cancer that was completely removed, or (c) is a cancer with a very good (≥ 80 %) five‑year survival chance and does not need active treatment now.
  • Having alcohol abuse, drug dependence, or substance abuse that could prevent following the study rules.
  • Having a current or imminent intestinal blockage (ileus). Patients whose ileus was treated and resolved are allowed.
  • Being pregnant or breastfeeding.
  • Having taken part in another clinical trial or experimental drug treatment within the last 28 days (or within five drug half‑lives, whichever is longer) or being enrolled in another trial at the same time.
  • Being financially or otherwise dependent on the study sponsor, investigator, or study site.
  • Being confined to a facility by a court or administrative order.
  • Being unable to give informed consent because you cannot understand the nature and importance of the trial.
  • Being unable to attend the required medical follow‑up visits because of geographic, social, or psychological reasons.
  • Having received chemotherapy before for metastatic or unresectable disease.
  • Having moderate to severe heart failure (New York Heart Association class III or higher).
  • Having had a heart attack (myocardial infarction) or a heart‑opening procedure called percutaneous transluminal coronary angioplasty (PTCA), with or without a stent, within the past 6 months.
  • Having unstable chest pain from heart disease (unstable angina).
  • Having a dangerous irregular heartbeat (arrhythmia) that is worse than grade 2 on the CTCAE scale despite medication.
  • Having ongoing side effects that are moderate or worse (grade > 2 on the CTCAE), especially nerve damage.
  • Having an active infection that is not under control.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Irinotecan

    is a chemotherapy medicine that stops cancer cells from copying their DNA, which prevents them from growing and spreading. In this study it is given through an IV infusion as one of the three drugs that make up the modified FOLFIRINOX treatment plan.

  • Oxaliplatin

    is a chemotherapy drug that damages the DNA inside cancer cells, making it harder for them to survive. It is used in both the FOLFOX and the modified FOLFIRINOX treatment groups and is also given by IV infusion.

  • 5‑Fluorouracil (5‑FU)

    is a chemotherapy agent that blocks the building blocks needed for DNA and RNA, which stops cancer cells from multiplying. In the trial it is administered by injection and is a key part of both treatment regimens.

  • Calcium Folinate

    (often called leucovorin) is not a chemotherapy drug itself, but it helps the body make 5‑FU work better against cancer cells. It is given by injection together with 5‑FU in the study.

What is already known about the treatment

  • Irinotecan

    This drug is supplied as a solution for infusion and is given by intravenous infusion. It is an approved chemotherapy medicine that is widely described in medical literature and used in many cancer treatment regimens. Irinotecan is mainly used for colorectal cancer and is a key component of the FOLFIRINOX regimen for gastrointestinal tumors. It works as a pro‑drug that is changed in the body to SN‑38, which blocks an enzyme called topoisomerase I, stopping cancer cells from copying their DNA; it belongs to the class of topoisomerase I inhibitors (antineoplastic agents).

  • Oxaliplatin

    Oxaliplatin is provided as a concentrate for infusion and is administered by intravenous infusion. It is an approved cancer drug with extensive clinical data and is commonly used in colorectal cancer therapy. Its main use is in the FOLFOX regimen for gastrointestinal cancers, including small bowel adenocarcinoma. The medication contains a platinum compound that creates cross‑links in the DNA of cancer cells, preventing them from dividing, and it is classified as a platinum‑based antineoplastic (alkylating‑like) agent.

  • Fluorouracil

    Fluorouracil comes as a solution for injection and is given by intravenous injection or infusion. It is a long‑standing, approved chemotherapy drug that appears in many clinical studies for solid tumors. The drug is primarily used for colorectal, breast, and head‑and‑neck cancers and forms part of both FOLFOX and FOLFIRINOX protocols. It mimics the natural building block uracil, gets incorporated into DNA and RNA, and blocks the enzyme thymidylate synthase, which stops cancer cells from making new DNA; it is categorized as an antimetabolite (pyrimidine analog).

  • Calcium Folinate

    Calcium folinate is supplied as a solution for injection and is administered intravenously, usually together with fluorouracil. It is an approved adjunct medication that is well documented for enhancing chemotherapy effects and reducing side effects. The main indication is to boost the activity of fluorouracil in cancers such as colorectal and small bowel adenocarcinoma. It provides a reduced form of folic acid that helps fluorouracil bind more tightly to its target enzyme, increasing the drug’s effectiveness, and it is classified as a folinic acid (vitamin B9) derivative used as a chemoprotective agent.

Investigated diseases

Locally advanced or metastatic small bowel adenocarcinoma - This disease is a cancer that begins in the glandular cells lining the small intestine. It can grow outward from the inner surface to involve deeper layers of the bowel wall. The tumor may spread to nearby lymph nodes and surrounding tissues, which is described as locally advanced. Cancer cells can also travel through the bloodstream or lymphatic system to distant organs, leading to metastatic disease. As the tumor expands, it can cause narrowing of the intestinal lumen, leading to blockage or changes in bowel habits.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-524131-39-00Protocol codeFIRE-12Estimated enrolment112 patientsSponsorCharite Universitaetsmedizin Berlin KöR

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).