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Study of drug combination therapy after surgery in patients with resectable pancreatic ductal adenocarcinoma using lab-grown mini-tumors to guide treatment selection

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What is this trial about?

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

This study focuses on patients with pancreatic ductal adenocarcinoma (PDAC) who have had surgery to remove their tumor. The research aims to use laboratory-grown miniature versions of tumors, called organoids, created from patients' cancer tissue to predict which chemotherapy treatment will work best for each individual after surgery.

The study involves several chemotherapy medications that are commonly used to treat pancreatic cancer. These include capecitabine, paclitaxel, irinotecan, gemcitabine, fluorouracil, oxaliplatin, and calcium folinate. Some medications are given by mouth, while others are administered through an intravenous line. The treatment period typically lasts for 6 months.

The research is divided into two parts. The first part checks if it's possible to grow these mini-tumors and test different chemotherapy combinations on them within 12 weeks after surgery. The second part examines how well patients do when their treatment is chosen based on how their laboratory-grown tumor responds to different chemotherapy combinations. The effectiveness of the treatment will be measured by tracking how long patients remain free of cancer after treatment.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial participation confirmation
After pancreatic cancer surgery, your tissue sample will be used to create organoids (miniature laboratory versions of your tumor).
The organoids will be tested to determine which chemotherapy might work best in your case.
Step 2
Medical assessment
Your doctor will check if you meet health requirements, including:
- Blood test results within specific ranges
- Kidney function showing creatinine clearance of 30 ml/min or higher
- Liver function tests within acceptable limits
- No signs of cancer spread after surgery
- General health status allowing for chemotherapy
Step 3
Treatment initiation
Treatment must begin within 12 weeks after surgery.
Based on organoid testing results, you will receive one of these chemotherapy combinations:
- mFOLFIRINOX: combination of fluorouracil, oxaliplatin, irinotecan, and calcium folinate given through vein
- Gemcitabine: given through vein
- Capecitabine: taken as tablets
- Gemcitabine with Capecitabine: combination of both medications
Step 4
Monitoring period
Regular check-ups will monitor your progress for at least 18 months.
You will complete quality of life questionnaires during this period.
Regular scans and blood tests will check for any signs of cancer return.
Step 5
Safety requirements
If you can become pregnant or father a child, you must use effective birth control during treatment and for 15 months afterward.
Regular blood tests will monitor your body's response to treatment.
Your doctor will check for and manage any side effects of the treatment.

Who can join the trial?

11 criteria

Must be 18 years or older
Must have pancreatic ductal cancer that can be surgically removed
Must have a Ca19-9 blood test result below 500 U/ml (Ca19-9 is a tumor marker used to monitor pancreatic cancer)
Must have good physical performance (ECOG score 0-1, meaning able to carry out light daily activities)
Must have adequate kidney function (creatinine clearance of 30 ml/min or higher)
Must have acceptable liver function tests: - Bilirubin levels between 1.5-3 times the normal limit - ALT and AST (liver enzymes) no more than 2.5 times the normal limit
Must have adequate blood cell counts: - White blood cells: 3.5 million or more per milliliter - Neutrophils (type of white blood cells): 1.5 million or more per milliliter - Platelets: 100 million or more per milliliter
Must be able to start chemotherapy within 12 weeks after surgery
Must have no signs of cancer spread to other organs (like liver, lung, or abdomen lining)
If able to have children, must agree to use effective birth control methods during treatment and for 15 months after the last treatment
Must provide signed informed consent to participate in the study

Who cannot join the trial?

13 criteria

Age below 18 years or above 75 years
Presence of pancreatic cancer that cannot be surgically removed
Ca19-9 (a blood tumor marker) level higher than 500 U/ml
Significant cholestasis (a condition where bile cannot flow from the liver to the small intestine)
Not meeting the NCCN criteria (standard guidelines for cancer treatment)
Unable to provide informed consent
Pregnancy or breastfeeding
Participation in other clinical trials
Active, uncontrolled infections
Serious heart, liver, or kidney conditions that could interfere with treatment
History of other cancers in the past 5 years (except for adequately treated non-melanoma skin cancer)
Mental conditions that could prevent following study procedures
Known allergies to study medications

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Verified sites

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

Charite Universitaetsmedizin Berlin KöR
Verified
Berlin, Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH
Verified
Ulm, Germany
Katholisches Klinikum Bochum gGmbH
Responsive
Bochum, Germany

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Investigated drugs

Based on the provided data, I cannot identify any specific medications or therapies to list, as the trial information focuses on using organoids to predict treatment efficacy in pancreatic cancer patients after surgery. The data doesn't specify any particular medications or therapeutic agents. The trial appears to be studying the feasibility of using organoid-based approaches for treatment selection rather than testing specific drugs. Without information about the actual medications or therapies being tested, I cannot provide the requested medication descriptions.

What is already known about the treatment

Since no specific medications are mentioned in the provided trial data, I cannot create medication descriptions in the requested format. The trial data only describes a study about using organoids to predict treatment efficacy in resectable pancreatic cancer (PDAC), but does not specify any particular medications being tested. If you would like medication descriptions, please provide trial data that includes specific medication names.

Investigated diseases

Pancreatic Ductal Adenocarcinoma (PDAC) - A type of cancer that begins in the cells lining the ducts of the pancreas. It develops when cells in the pancreatic ducts begin to grow uncontrollably, forming a tumor. The disease typically progresses by growing locally within the pancreas and can spread to nearby structures. PDAC can affect the pancreas's ability to produce digestive enzymes and hormones that regulate blood sugar. The cancer cells can form masses that interfere with normal pancreatic function and may spread to other parts of the body. This type of cancer often develops gradually, and early stages may not cause noticeable symptoms.