Recruiting

Study on Timing of Chemotherapy with Paclitaxel Albumin-Bound and Drug Combination for Patients with Metastatic Pancreatic Cancer

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What is this trial about?

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

This clinical trial is focused on studying the treatment of metastatic pancreatic cancer, which is a type of cancer that has spread from the pancreas to other parts of the body. The study aims to understand the effects of starting chemotherapy immediately versus delaying it on the overall survival of patients, while considering their quality of life. The medications being tested in this study include Abraxane (paclitaxel albumin-bound), Campto (irinotecan hydrochloride trihydrate), Gemcitabine Accord (gemcitabine), 5-Fluorouracil Sandoz (fluorouracil), and Oxaliplatine SUN (oxaliplatin). These medications are administered through an intravenous infusion, which means they are given directly into a vein.

Participants in the study will be divided into groups to receive either the immediate or delayed start of chemotherapy. The study will monitor the participants over a period to assess their overall survival and quality of life. The trial will also look at how long it takes for the disease to progress and any side effects experienced by the participants. The goal is to determine the best timing for starting chemotherapy to improve the quality of life and survival for patients with metastatic pancreatic cancer.

The study will continue until 2027, and it will gather data on various outcomes, including the time without symptoms or side effects and changes in specific cancer markers. This information will help doctors make informed decisions about the timing of chemotherapy for patients with this type of cancer. Participants will be closely monitored throughout the study to ensure their safety and well-being.

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
Joining the study
Upon joining the study, you will be required to sign a document called the Informed Consent Form. This form confirms your understanding of the study and your agreement to participate.
You will undergo a series of tests to confirm your eligibility. These tests include a CT scan to measure the disease, and various blood tests to check your health status.
Step 2
Treatment decision
The study aims to compare the effects of starting chemotherapy immediately versus delaying it. You will be assigned to one of these two groups based on your preference and the study's requirements.
The main goal is to assess how the timing of treatment affects your overall survival and quality of life.
Step 3
Chemotherapy administration
If you are in the immediate treatment group, you will start receiving chemotherapy. The medications used include paclitaxel albumin-bound, irinotecan hydrochloride trihydrate, gemcitabine, fluorouracil, and oxaliplatin. These are administered through a vein, a process known as intravenous administration.
The specific dosage and frequency of each medication will be determined by your healthcare provider based on your individual needs and the study protocol.
Step 4
Monitoring and follow-up
Throughout the study, your health and response to treatment will be closely monitored. This includes regular visits to the clinic for check-ups and additional tests as needed.
You will be asked to report any side effects or changes in your condition to the study team.
Step 5
End of study participation
The study is expected to continue until July 16, 2027. Your participation may end earlier if you choose to withdraw or if your doctor decides it is in your best interest.
At the end of your participation, you will have a final evaluation to assess your health and the outcomes of the treatment.

Who can join the trial?

20 criteria

Signed, written consent form approved by an ethics committee.
No previous chemotherapy for cancer that has spread to other parts of the body. However, patients may have had treatment after surgery more than 6 months before the cancer spread, or treatment before surgery for cancer that could be removed.
Patients must have a confirmed diagnosis of metastatic pancreatic ductal adenocarcinoma (a type of pancreatic cancer that has spread).
The disease must be measurable on a CT scan (a type of detailed imaging test) according to specific criteria.
Patients must have an Eastern Cooperative Oncology Group Performance Status of 0-1, which means they are fully active or have some symptoms but do not need bed rest during the day.
Life expectancy of at least 3 months.
Age 18 years or older.
If female and able to have children, a negative pregnancy test is required within 7 days before the first dose of study medication.
Specific laboratory test results within normal ranges, including:
- Absolute neutrophil count (a type of white blood cell) greater than 1.5 x 10⁹/L.
- Total bilirubin (a liver function test) less than or equal to 1.5 times the upper limit of normal.
- Aspartate aminotransferase and alanine aminotransferase (liver enzymes) less than or equal to 2.5 times the upper limit of normal, or less than or equal to 5 times if there are liver metastases.
- Serum creatinine (a kidney function test) less than 1.5 times the upper limit of normal or creatinine clearance greater than 50 mL/min/1.73 m².
- Prothrombin time/international normalized ratio within normal limits or within therapeutic range if taking warfarin (a blood thinner). Partial thromboplastin time within normal limits.
- Platelet count (cells that help with blood clotting) greater than 100,000 x 10⁹/L.
- No symptoms related to advanced disease, such as:
  - No pain requiring regular strong painkillers.
  - No weight loss over 5 kg unless due to surgery or other illness.
  - No persistent nausea requiring medication.
  - No bowel blockage symptoms.
  - No persistent fever related to cancer.
  - No other symptoms due to worsening cancer, as judged by the doctor.

Who cannot join the trial?

3 criteria

Patients who do not have metastatic pancreatic cancer cannot participate. Metastatic means that the cancer has spread to other parts of the body.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have difficulty giving informed consent or are at higher risk of harm.

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Verified sites

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Amsterdam UMC
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Amsterdam, The Netherlands
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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Rotterdam, The Netherlands
Leids Universitair Medisch Centrum (LUMC)
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Leiden, The Netherlands

Trial locations

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Investigated drugs

Chemotherapy is a type of cancer treatment that uses drugs to destroy cancer cells. In this trial, chemotherapy is being used to treat patients with metastatic pancreatic cancer. The goal is to see how starting chemotherapy immediately compares to delaying its start in terms of improving the quality and length of life for patients. Chemotherapy works by targeting and killing rapidly dividing cancer cells, which can help to slow down or stop the growth of the cancer.

What is already known about the treatment

TIMEPAN Chemotherapy – This medication is administered through systemic treatment, which means it is given in a way that affects the entire body, often through an intravenous (IV) infusion. Currently, it is being studied in clinical trials to determine the best timing for starting chemotherapy in patients with metastatic pancreatic cancer, focusing on whether starting treatment immediately or delaying it improves overall survival and quality of life. The main therapeutic use of this medication is to treat metastatic pancreatic cancer, which is a type of cancer that has spread from the pancreas to other parts of the body. At the molecular level, chemotherapy works by targeting and killing rapidly dividing cancer cells, although it can also affect some healthy cells. This medication falls under the pharmacological classification of antineoplastic agents, which are drugs used to treat cancer.

Investigated diseases

Metastatic Pancreatic Cancer – Metastatic pancreatic cancer is a type of cancer that originates in the pancreas and has spread to other parts of the body. The disease begins in the tissues of the pancreas, which is an organ located behind the lower part of the stomach. As the cancer progresses, it can invade nearby organs and spread to distant sites such as the liver, lungs, and peritoneum. The progression of the disease is characterized by the growth of cancerous cells that form tumors, which can interfere with the normal function of affected organs. Symptoms may include abdominal pain, weight loss, jaundice, and digestive issues. The disease is often diagnosed at an advanced stage due to its subtle early symptoms.