Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

Ramucirumab plus Irinotecan / Leucovorin / 5-FU versus Ramucirumab plus Paclitaxel in patients with advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction, who failed one prior line of palliative chemotherapy - The Phase II/III RAMIRIS STUDY

This research study, called RAMIRIS, is for people with advanced stomach or food pipe cancer that has spread to other parts of the body, or has returned. Participants have already had one round of chemotherapy that didn't fully control their cancer. The study aims to find out if combining the drug ramucirumab with one of two different chemotherapy regimens (irinotecan/leucovorin/5-FU or paclitaxel) is better for patients. Researchers will compare how long people live, if their cancer shrinks, how well they tolerate the treatment, and their quality of life. This is a Phase III study, meaning it's a final big step to see if these treatments should become standard care.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Enrolment target

319

Start

04 Nov 2024

advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junctions who failed prior line of palliative chemotherpay

What is this study about?

This study is exploring new treatment options for a type of cancer that starts in the stomach or where the food pipe joins the stomach. This cancer is considered advanced because it has spread to other parts of the body, or it has come back after previous treatment. The participants in this study have already received one type of chemotherapy for their cancer, but unfortunately, it hasn't been successful enough in controlling it.

The main goal of this study is to compare two different ways of combining medicines to treat this cancer. Everyone in the study will receive a drug called ramucirumab. One group will get ramucirumab along with a chemotherapy combination called Irinotecan/Leucovorin/5-FU. The other group will get ramucirumab with a different chemotherapy drug called Paclitaxel. Researchers want to see which combination is more effective at helping people live longer and shrinking their cancer.

They will also be looking at other important things, like how well people tolerate the treatment (meaning, what side effects they experience), if their cancer stops growing for a longer period, and how the treatments affect their day-to-day life and overall well-being. This is a Phase III study, which is a big step in research, and the findings will help doctors understand the best way to treat this cancer in the future.

Key takeaways

This study is for advanced stomach or food pipe cancer that has already been treated with one chemotherapy.
It compares two different combinations of medicines including Ramucirumab with either Irinotecan/Leucovorin/5-FU or Paclitaxel.
The main goals are to see which treatment helps people live longer and shrinks their cancer more effectively.
Researchers will also look at side effects and how treatments affect daily life.
Participation means regular visits for treatment, blood tests, and scans.
You can stop participating at any time if you wish.

Who may be eligible?

To join this study, people must be aged 18 or older. Both men and women are welcome to take part.

You would be eligible if you have been diagnosed with advanced cancer of the stomach or the area where your food pipe meets your stomach. This means the cancer has either spread to other parts of your body, or it has returned after being treated before.

It's also important that you have already received one round of chemotherapy for your advanced cancer, and that treatment, unfortunately, did not fully control the cancer. Your doctors will check other health details to make sure this study is safe and suitable for you.

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 advanced stomach or food pipe cancer that has spread or returned?
Have you already had one round of chemotherapy for your advanced cancer?
Did that previous chemotherapy not fully control your cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the doctors and nurses will explain everything in detail. You will be randomly assigned to receive one of the two treatment combinations mentioned: either ramucirumab with Irinotecan/Leucovorin/5-FU, or ramucirumab with Paclitaxel. You won't be able to choose which treatment you get, as this helps make the study fair.

The treatments will be given as infusions, which means the medicines go directly into your bloodstream through a drip, usually in a hospital or clinic. You will have regular appointments for these treatments and for check-ups. These check-ups will involve blood tests, scans (like CT scans) to see how the cancer is responding, and discussions about how you're feeling and any side effects you might be experiencing. You may also be asked to fill out questionnaires about your quality of life.

The frequency of visits and the total duration of your participation will depend on how you respond to the treatment and the study plan. You will be closely monitored throughout your time in the study.

Potential risks and benefits

Participating in a clinical trial offers the chance to receive a new treatment that might be more effective than standard options, or it could lead to discovering better treatments for others in the future. However, there are potential risks, as all medicines can have side effects. These can range from mild, like feeling tired or sick, to more serious effects. The study team will carefully monitor you for any side effects and manage them as best as possible. You will receive very close medical attention and care throughout the study. It's important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (3)

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

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Unverified
Italy
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Unverified
Austria
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Unverified
Germany

Common questions

What does 'advanced or metastatic' mean?

It means the cancer has spread from where it started to other parts of the body.

What does 'failed one prior line of palliative chemotherapy' mean?

It means you have already had one type of chemotherapy treatment for your cancer, but it wasn't successful in fully controlling or shrinking the cancer.

What is 'Ramucirumab'?

Ramucirumab is a type of targeted drug that works by blocking a protein that helps tumours grow blood vessels and get nutrients.

What are 'Irinotecan', 'Leucovorin', '5-FU', and 'Paclitaxel'?

These are all different chemotherapy drugs that work by killing cancer cells or stopping them from growing.

What is a 'Phase III' study?

A Phase III study is a large study that compares a new treatment with an existing one, or another new treatment, to confirm its effectiveness and safety before it can become available to more people.