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Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

THE (COST)EFFECTIVENESS OF NEOADJUVANT FOLFIRINOX VERSUS NEOADJUVANT GEMCITABINE BASED CHEMORADIOTHERAPY AND ADJUVANT GEMCITABINE FOR (BORDERLINE) RESECTABLE PANCREATIC CANCER (PREOPANC-2 STUDY)

This important study, known as PREOPANC-2, is exploring the best way to treat pancreatic cancer that can either be removed by surgery or is very close to being removable. Researchers are comparing two main treatment approaches. One approach involves giving a strong combination of several medicines (called FOLFIRINOX) before surgery. The other approach involves giving a different powerful medicine (Gemcitabine) along with radiotherapy before surgery, followed by more Gemcitabine after surgery. The aim is to find out which of these treatment pathways helps patients live longer and offers the best chance of recovery. Participants will be aged 18 or over, and the study is open to both men and women.

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic confirmatory (Phase III)
Sponsor
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
Enrolment target
368
Start
09 Oct 2024

What is this study about?

Imagine you or a loved one has been diagnosed with pancreatic cancer that doctors believe can either be removed with an operation, or is borderline and might become removable after some initial treatment. This study, called PREOPANC-2, is a big step to figuring out the best way to treat people in this situation.

Currently, doctors have different ideas about the best approach. Some think a specific combination of strong medicines called FOLFIRINOX given before surgery might be best. Others believe giving another powerful medicine called Gemcitabine, combined with radiotherapy (which uses high-energy rays to kill cancer cells) before surgery, and then more Gemcitabine after surgery, could be more effective. This study is designed to carefully compare these two main treatment plans.

By comparing these treatments side-by-side, researchers hope to discover which one leads to better outcomes for patients, especially in terms of how long people live after treatment. It's about finding the safest and most effective path forward for people facing this challenging diagnosis.

Key takeaways

  • This study compares two main treatment plans for pancreatic cancer that can or might be surgically removed.
  • It aims to find out which treatment helps people live longer and has the best outcomes.
  • You would receive either FOLFIRINOX chemotherapy OR Gemcitabine chemotherapy plus radiotherapy before surgery.
  • Participation involves regular hospital visits for treatments, tests, and follow-up.
  • All participants are 18 years or older and have non-metastatic, resectable or borderline resectable pancreatic cancer.
  • Your decision to join is voluntary, and you can leave the study at any time.

Who may be eligible?

This study is looking for adults aged 18 years and older. Your doctor will need to confirm you have pancreatic cancer that has not spread to other parts of your body, and that it is considered either 'resectable' (meaning it can definitely be removed by surgery) or 'borderline resectable' (meaning it might be removable with surgery after some initial treatment).

Both men and women are welcome to take part in this study. There will be other medical checks and tests that your doctor will go through with you to make sure this study is the right and safest option for your personal health situation.

It’s important to discuss all your current health conditions and any other medicines you are taking with your doctor, as these might affect whether you can join the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Have you been diagnosed with pancreatic cancer that has not spread to other parts of your body?
  3. Is your cancer considered 'resectable' (can be removed surgically) or 'borderline resectable' (might be removed after initial treatment)?
  4. Are you able to attend regular hospital appointments and tests?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to one of two treatment groups – a bit like flipping a coin, so it's fair. You would either receive a course of FOLFIRINOX chemotherapy before surgery, or you would receive Gemcitabine chemotherapy along with radiotherapy before surgery, followed by more Gemcitabine after your operation.

Throughout the study, you would have regular hospital visits for treatments, check-ups, blood tests, and scans to monitor your health and how the treatment is working. Your medical team will carefully explain the schedule of these appointments. The total duration of your participation, including follow-up appointments after your main treatment, would be over an extended period, allowing doctors to understand the long-term effects of the treatments. This follow-up is crucial for the study to provide valuable information.

Potential risks and benefits

Taking part in this study could potentially offer you access to treatments that are carefully monitored by a team of experts, and you would contribute to important medical research that could help future patients. However, like all medical treatments, there are potential side effects associated with the medicines and radiotherapy used, which your doctor will discuss in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Unverified
    Netherlands

Common questions

What kind of cancer is this study for?

This study is for pancreatic cancer that hasn't spread and doctors think can either be removed by surgery or might become removable after initial treatment.

What does 'neoadjuvant' mean?

Neoadjuvant means receiving treatment, like chemotherapy or radiation, before your main surgery.

Will I get to choose my treatment?

No, you will be randomly assigned to one of the two treatment groups, just like drawing lots, to ensure the study is fair and unbiased.

How long will I be in the study?

The study involves treatment periods followed by long-term check-ups to see the continued effects of the treatment. Your doctors will let you know the expected overall duration.

What are the main medicines used?

The study uses combinations of chemotherapy medicines like Irinotecan, Folic Acid, Gemcitabine, Fluorouracil, and Oxaliplatin.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

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