RecruitingOBSERVATIONAL

GastrOesophageal Tumor, Immune Microenvionnment (GOTIM)

This study, called GOTIM, aims to understand how your body's immune system responds to stomach and food pipe cancer (gastroesophageal cancer) when treated with standard chemotherapy before surgery. Researchers will collect samples, like blood, at different points during treatment – before, during, and after – to look closely at immune cells. They also want to track tiny bits of cancer DNA in your blood to see if the treatment is working effectively and to monitor for any remaining cancer cells. This isn't a new treatment; it's about learning more from patients already receiving established care. The information gathered could help doctors in the future to better predict how patients will respond to treatment and to develop more personalised approaches for fighting these cancers.

At a glance

Status

Recruiting

Sponsor

Centre Leon Berard

Enrolment target

Start

19 Jul 2023

Estimated completion

15 Jan 2028

GastroEsophageal Cancer

What is this study about?

When you have stomach or food pipe cancer, your body's natural defence system, called the immune system, tries to fight it. This study, named GOTIM, wants to take a closer look at how your immune system behaves around the tumour, both before you start standard chemotherapy (drug treatment) and after. Imagine it like a battleground; researchers want to understand who the players are (different immune cells) and what strategies they're using against the cancer. This knowledge is important because a stronger immune response might mean treatments work better.

Doctors are also interested in something called "liquid biopsies." This means checking blood samples for tiny fragments of cancer cells or their DNA. By tracking these small amounts during and after treatment, they hope to get an early warning about how well the treatment is working or if any cancer cells are still present after surgery. This could eventually lead to more personalized care, where doctors can tailor treatments based on exactly what's happening inside your body.

It's important to know that this study isn't testing a new drug or treatment method. Instead, it's about gathering valuable information from patients who are already receiving the best standard care for their stomach or food pipe cancer. The goal is to learn more about the disease and how the body responds to treatment, which could help improve patient care and develop new, more effective strategies for the future.

Key takeaways

This study helps scientists understand how your body's immune system fights stomach and food pipe cancer.
It uses samples from patients already getting standard cancer treatment.
No new medicines are given; you receive your usual care.
Participation involves giving extra blood samples and allowing access to tumour tissue.
The information gained could help improve future cancer treatments.

Who may be eligible?

To be part of this study, you need to be at least 18 years old. You must have been diagnosed with stomach or food pipe cancer that doctors believe can be removed by surgery, and you should be planning to have standard chemotherapy before your operation. Your surgery also needs to be planned at Centre Léon Bérard.

We would also need to have a sample of your tumour tissue that was taken during your initial diagnosis, which we can use for testing. You should generally be feeling well enough to carry out most daily activities, with an ECOG performance status of 0, 1 or 2. You will also need to agree to and understand the study and be able to attend all necessary appointments.

There are also some reasons why you might not be able to join. For example, if you have another ongoing cancer that needs treatment, or if you are pregnant or breastfeeding. Also, if there's any reason that might make it hard for you to give proper consent or stick to the study visits, you might not be able to take part.

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?
Do you have stomach or food pipe cancer that can be removed by surgery?
Are you planning to have standard chemotherapy before your surgery?
Is your surgery planned at Centre Léon Bérard?
Are you generally well enough for daily activities (ECOG 0, 1, or 2)?
Are you able and willing to attend study appointments?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you won't be given any new medicines. All your cancer treatment, including chemotherapy and surgery, will be the standard care your doctors have already planned for you. You will need to provide extra blood samples at a few different times: before you start chemotherapy, during your chemotherapy treatment, and after your surgery. Researchers will also use a small piece of the tumour tissue that was collected when you were first diagnosed. This study will follow you through your neoadjuvant (before surgery) and adjuvant (after surgery) therapy periods. The total duration of your participation will depend on your treatment plan.

Potential risks and benefits

One potential benefit of taking part is that you'll contribute to a better understanding of stomach and food pipe cancer, which could help future patients. There are no direct benefits to your own treatment, as you'll be receiving standard care. The main risks involve the discomfort of extra blood draws and giving a tissue sample. You also have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Centre Léon Bérard
Verified postcode
Lyon, France· Recruiting

Common questions

What kind of cancer is this study about?

This study is looking at stomach cancer and cancer where the food pipe joins the stomach (gastroesophageal junction cancer).

Will I get a new medicine in this study?

No, this study does not involve giving you new medicines. You will receive the standard treatment that your doctor has already planned for your cancer.

Why do you need blood samples?

Blood samples help researchers understand how your immune system is responding to the cancer and treatment, and to look for tiny signs of cancer cells.

How long will I be in the study?

You will be in the study throughout your chemotherapy before surgery and any treatment you have after surgery. The exact time depends on your personal treatment plan.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, and it will not affect your medical care.

How to find out more

Clélia COUTZAC, MD

clelia.coutzac@lyon.unicancer.fr 04 78 78 60 20 Official trial record

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