All studies
Active not recruitingPHASE3INTERVENTIONAL

Assessing Durvalumab and FLOT Chemotherapy in Resectable Gastric and Gastroesophageal Junction Cancer

This research study is for people with stomach (gastric) or food pipe (gastroesophageal junction) cancer that can be completely removed by surgery. It's investigating a new drug called durvalumab alongside a standard chemotherapy treatment called FLOT. Patients will receive either durvalumab or a dummy drug (placebo) with FLOT chemotherapy before their surgery. After surgery, they will continue to receive either durvalumab or the placebo. The main goals are to find out if this treatment approach is safe, effective in treating the cancer, and to learn more about these types of cancer and related health issues. The study is open to both men and women aged 18 and over.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
AstraZeneca
Enrolment target
957
Start
17 Nov 2020
Estimated completion
27 Sep 2027

What is this study about?

This study, called MATTERHORN, is designed for people who have stomach cancer or cancer where the food pipe joins the stomach (gastroesophageal junction cancer). These are cancers that can be completely removed through an operation. The study wants to find out if adding a newer drug called durvalumab to standard chemotherapy (a combination of drugs known as FLOT) helps treat these cancers better and more safely.

Participants will be placed into one of two groups by chance. One group will receive durvalumab with FLOT chemotherapy, while the other group will receive a 'dummy' drug (called a placebo) with FLOT chemotherapy. This treatment is given in two parts: first, before the surgery to remove the cancer, and then again after the surgery. Doctors will be carefully checking how well the treatment works and if there are any side effects.

By comparing the results from both groups, the researchers hope to understand if this new combination of treatments can improve the chances of a successful outcome for patients with these types of cancer. It will also help them learn more about the diseases themselves.

Key takeaways

  • This study is for stomach or food pipe cancer that can be removed by surgery.
  • It tests a new drug (durvalumab) with standard chemotherapy (FLOT).
  • Treatment is given both before and after your operation.
  • You might receive the new drug or a dummy drug alongside chemotherapy.
  • All treatment and appointments are provided by the study team.
  • You can stop participating in the study at any time.

Who may be eligible?

To join this study, you would need to have stomach or food pipe cancer that doctors believe can be fully removed with an operation. This would be confirmed by special tests and a sample of your tumour. You shouldn't have started any other cancer treatment for your current cancer yet.

You would need to be well enough to take part, meaning you can carry out most of your daily activities without too much difficulty. Your body's organs, like your kidneys and liver, would also need to be working properly. The medical team would take a look at your general health to make sure it's safe for you to join.

There are also some reasons why you might not be able to join. For example, if your cancer has spread widely to other parts of your body, or if you have certain other types of cancer. You also couldn't take part if you've recently used medicines that suppress your immune system, or if any of the study drugs would be unsafe for you due to other health conditions. Having had an organ transplant in the past would also prevent you from joining.

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. Do I have stomach or food pipe cancer that doctors believe can be fully removed by surgery?
  2. Have I had any previous cancer treatment for my current cancer?
  3. Am I well enough to manage most daily activities without too much trouble?
  4. Do I have any other medical conditions that might prevent me from safely taking trial drugs?
  5. Is my cancer confined to the stomach or food pipe area, without widespread spread?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive treatment both before and after your cancer surgery. This involves getting injections of either durvalumab or a placebo, combined with FLOT chemotherapy, in cycles. You will have regular visits to the clinic for these treatments, as well as for various tests like blood tests, scans, and physical exams to monitor your health and how the treatment is working.

After your surgery, you will continue with follow-up appointments and may receive more study treatment. The total duration of active treatment and close monitoring will depend on your individual response and how long you remain on the study, but participation could last for several months to a couple of years. Even after your treatment ends, there will be a follow-up period to check on your long-term health.

Potential risks and benefits

Taking part in a clinical trial like this could offer potential benefits, such as receiving a new and potentially effective treatment earlier than it might otherwise be available, and contributing to medical knowledge that could help future patients. However, there are also potential risks; the treatments might cause side effects, and it's possible they won't work for everyone. All known side effects would be explained in detail by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (156)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research Site
    Verified postcode
    Duarte, United States
  • Research Site
    Verified postcode
    Los Angeles, United States
  • Research Site
    Verified postcode
    Los Angeles, United States
  • Research Site
    Verified postcode
    Sylmar, United States
  • Research Site
    Verified postcode
    St. Petersburg, United States
  • Research Site
    Verified postcode
    Tallahassee, United States
  • Research Site
    Verified postcode
    West Palm Beach, United States
  • Research Site
    Verified postcode
    Fort Wayne, United States
  • Research Site
    Verified postcode
    Louisville, United States
  • Research Site
    Verified postcode
    Boston, United States
  • Research Site
    Verified postcode
    New York, United States
  • Research Site
    Verified postcode
    Rochester, United States

Common questions

What is gastroesophageal junction cancer?

It's a type of cancer that develops in the area where your food pipe (oesophagus) meets your stomach.

What does 'resectable' mean?

It means the cancer can be completely removed from your body by surgery.

What is a 'placebo'?

A placebo is a 'dummy' treatment that looks like the real drug but contains no active medicine. It helps compare the new drug's effects accurately.

What are 'neoadjuvant' and 'adjuvant' treatments?

Neoadjuvant treatment is given before surgery, and adjuvant treatment is given after surgery. Both aim to improve outcomes.

Can I choose which treatment I get?

No, participants are randomly assigned to either the durvalumab or placebo group, so it's decided by chance, like flipping a coin.

How to find out more

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

Discussion

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