AuthorisedTherapeutic exploratory (Phase II)Interventional

Phase II study to evaluate the efficacy of 12-month neoadjuvant chemotherapy in terms of disease-free survival in patients with localized digestive neuroendocrine carcinomas - NEONEC D19-01

This study is investigating a new approach to treating a type of cancer called localised digestive neuroendocrine carcinoma. Researchers want to see if giving a specific chemotherapy treatment for 12 months before surgery can improve how long patients stay free from cancer returning. They will be using medicines like Etoposide, Carboplatin, and Cisplatin. This is a Phase II study, meaning it's exploring how effective the treatment is. The main goal is to measure how many patients are cancer-free (without the cancer coming back locally or spreading, and without passing away) one year after starting the treatment. It's hoped this research could lead to better ways to treat this type of cancer.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Association Gercor

Enrolment target

Start

23 Jan 2025

Localized digestive Neuroendocrine Carcinomas

What is this study about?

This study is for people who have a type of cancer called localised digestive neuroendocrine carcinoma. Localised means the cancer hasn't spread to other parts of the body yet. The researchers want to find out if giving chemotherapy medicines *before* surgery can help patients stay cancer-free for longer. They are particularly interested in how many people are still free from cancer coming back, either locally or elsewhere, after one year.

The chemotherapy treatment being tested uses a combination of medicines: Etoposide, Carboplatin, and Cisplatin. These are well-known cancer drugs. Sometimes, giving treatment before surgery, called neoadjuvant therapy, can shrink the tumour, making surgery easier or more effective. This study will carefully monitor how patients respond to this treatment before and after surgery.

The study will also look at many other things, like how well the treatment shrinks the tumour, whether patients can still have surgery, how much of the tumour is gone after surgery, and how long people live overall. They'll also be keeping a close eye on any side effects and looking at specific features of the tumour using special tests to understand why some treatments work better for certain people.

Key takeaways

This study investigates chemotherapy before surgery for a specific cancer.
It aims to see if treatment helps patients stay cancer-free longer.
Common chemotherapy drugs (Etoposide, Carboplatin, Cisplatin) are used.
Eligible participants are adults aged 18 and over with localised digestive neuroendocrine carcinoma.
Participation involves chemotherapy, surgery, and regular follow-up appointments.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 or older. Both men and women can take part.

You would need to have been diagnosed with localised digestive neuroendocrine carcinoma, meaning the cancer is still in the area it started and hasn't spread throughout your body.

There might be other specific health requirements or conditions that would determine if this study is right for you, so it's important to discuss all the details with your doctor.

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.

Are you 18 years old or older?
Have you been diagnosed with localised digestive neuroendocrine carcinoma?
Is your cancer still in the area it started and hasn't spread?
Are you prepared to discuss all aspects of the study with your doctor?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive chemotherapy medicines for a period before you have your surgery. You would have regular appointments to monitor your health and how the treatment is working. This would involve scans and blood tests. Doctors would also keep track of any side effects you might experience. After your surgery, there will be follow-up appointments to check on your recovery and health. The study will also involve collecting samples, like tissue from your tumour and blood, for special tests to understand more about your cancer. The total duration of your active participation, including treatment and follow-up, would be discussed with you by the study team.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to new treatments before they are widely available and close monitoring of your health. However, there are also potential risks, including side effects from the chemotherapy medicines or other procedures. These will be thoroughly explained to you, and the study team will monitor you closely. It's important to remember that this treatment might not work for everyone. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
France

Common questions

What is 'localised digestive neuroendocrine carcinoma'?

It's a type of cancer that starts in certain hormone-producing cells in your digestive system and has not spread to other parts of your body yet.

What does 'neoadjuvant chemotherapy' mean?

It means chemotherapy treatment given before surgery to try and shrink the cancer or make the surgery more effective.

What medicines are being used in this study?

The study uses a combination of chemotherapy medicines called Etoposide, Carboplatin, and Cisplatin.

What is the main goal of this study?

The main goal is to see if giving chemotherapy before surgery helps people stay free from cancer for one year after treatment.

Will my doctors know about my participation?

Yes, your medical team will be fully aware and involved if you choose to participate in the study.