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RecruitingPHASE2INTERVENTIONAL

Chemotherapy For Metastatic Grade 3 Poorly Differentiated NEuroendocrine Carcinoma Of GastroEnteroPancreatic And Unknown Primary

This research is focused on a rare but serious type of cancer called Grade 3 Neuroendocrine Carcinoma (often found in the gut, pancreas, or with an unknown starting point) that has spread to other parts of the body. The standard treatment for this cancer is a chemotherapy combination that works for a while, but the cancer often comes back. This study aims to find a more effective chemotherapy treatment, specifically testing a combination called mFOLFIRINOX against the current standard. Researchers also want to understand why certain treatments work better for some patients than others by looking closely at the cancer cells. The goal is to provide more personalised and effective care for people with this type of cancer, ultimately improving their lives.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Centre Hospitalier Universitaire Dijon
Enrolment target
218
Start
01 Sep 2020
Estimated completion
01 Sep 2029

What is this study about?

This study is about an advanced cancer called Grade 3 Neuroendocrine Carcinoma (NEC). This is a rare cancer that often spreads early on. When it's found, it's usually already in other parts of the body, which makes it harder to treat. The current main treatment is a type of chemotherapy, but while it can shrink the cancer for a time, it often doesn't last very long, and the cancer can grow back quickly. This means there's a real need for better treatments.

The researchers in this study are looking at whether a newer chemotherapy combination, called mFOLFIRINOX, might be more effective than the standard treatment. They want to see if it can keep the cancer from growing for longer and potentially help people live longer. They're also trying to understand more about the cancer itself – specifically, why some treatments work better for certain patients. By studying the cancer cells closely, they hope to find clues (called 'biomarkers') that can predict which treatment will be most helpful for each person.

Ultimately, the goal of this FOLFIRINEC trial is to improve the lives of people with this type of cancer. By comparing different treatments and learning more about the cancer's unique features, doctors hope to offer more personalised and successful treatment plans in the future. This could mean more effective chemotherapy that works for longer and helps people feel better.

Key takeaways

  • This study is for advanced Grade 3 Neuroendocrine Carcinoma.
  • It aims to find more effective chemotherapy options.
  • Compares a new chemotherapy (mFOLFIRINOX) to the standard treatment.
  • Also looking for ways to match treatments to individual patients.
  • Open to adults who haven't had prior chemotherapy for metastatic disease.

Who may be eligible?

This study is for adults aged 18 or older who have a specific type of advanced cancer called Grade 3 Neuroendocrine Carcinoma. This cancer must have started in the gut, pancreas, or its origin is unknown, and it must have spread to other parts of the body. You would also need to be generally well and able to carry out most daily activities on your own.

To be considered, you must have not had any previous chemotherapy for your advanced cancer. Your organs, like your kidneys and liver, need to be working well, and your blood counts must be at healthy levels. The doctors will also need to be able to measure your cancer to see if the treatment is working.

There are also some reasons why you wouldn't be able to join. For example, if your cancer is a different type (well-differentiated neuroendocrine tumour), if you have severe kidney problems, certain nerve damage, or if you've already had chemotherapy for your advanced cancer. You also can't be pregnant, breastfeeding, or planning to get pregnant during 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. Do you have Grade 3 Neuroendocrine Carcinoma (from gut/pancreas or unknown origin) that has spread?
  3. Have you NOT had chemotherapy for your cancer that has spread?
  4. Are you generally well and active?
  5. Are your organs (like kidneys, liver) generally healthy?
Answer every question to see your result.

What does participation involve?

The specific details of what taking part involves are not fully described in the provided information. However, generally in a chemotherapy study like this, you would likely: receive one of the study's chemotherapy treatments (either the new one or the standard one), have regular doctor's appointments, and undergo various tests like blood tests and scans (CT or MRI) to monitor your health and how the treatment is working. This would involve visits to the hospital or clinic over several months, with ongoing follow-up after the main treatment phase. The full duration of your participation, including follow-up, would be discussed by the study team.

Potential risks and benefits

Taking part in a clinical trial like this could mean you receive a new treatment that might work better than current options for your cancer. However, there's no guarantee the new treatment will be more effective, and it might have different side effects than standard treatments. Both treatments being studied (the new one and the standard one) can cause side effects. Your doctor will explain all potential risks and benefits. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

  • Chu de Caen
    Verified postcode
    Caen, France· Recruiting
  • Chu Dijon Bourgogne
    Verified postcode
    Dijon, France· Recruiting
  • Institut de Cancérologie de Bourgogne
    Verified postcode
    Dijon, France· Recruiting
  • Chu de Limoges - Dupuytren
    Verified postcode
    Limoges, France· Recruiting
  • Centre Hospitalier de Saint Malo
    Verified postcode
    St-Malo, France· Recruiting
  • CH de Troyes
    Verified postcode
    Troyes, France· Recruiting

Common questions

What is Grade 3 Neuroendocrine Carcinoma?

It's a rare and aggressive type of cancer that often starts in the digestive system or pancreas and has usually spread by the time it's diagnosed.

Why is this study important?

The goal is to find better chemotherapy treatments for this cancer, as current options don't always keep the cancer away for very long. It also aims to personalise treatment more.

What kind of treatments are being tested?

The study compares a chemotherapy blend called mFOLFIRINOX with the standard chemotherapy known as platinum-etoposide.

Will I know which treatment I'm getting?

Often in studies like this, you might not know if you're getting the new treatment or the standard one, to ensure fair comparison. The study team will explain how this works.

Is this study available to everyone?

No, there are specific health requirements and previous treatment history that determine if someone can join. Your doctor can check if you meet the criteria.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "Chemotherapy For Metastatic Grade 3 Poorly Differentiated NE…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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