Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

PRODIGE 55-SOCRATE : A randomized phase II study to evaluate second-line ramucirumab alone or with paclitaxel in older patients with advanced gastric cancer

This research is a 'Phase II' study, which means it's still in the early stages of testing new treatments. It's for older patients with advanced stomach cancer that has spread to other parts of the body (stage IV with metastases). The main goal is to see if one of two treatment approaches — a drug called ramucirumab by itself, or ramucirumab combined with another drug called paclitaxel — can help people live longer and improve their quality of life. The study will carefully monitor how patients feel and how well the treatment works over several months, looking at things like how long people survive and their overall well-being.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fondation Franc.Cancerologie Digestive

Enrolment target

112

Start

10 Jul 2024

stomach cancer stage IV with metastases

What is this study about?

This study, called PRODIGE 55-SOCRATE, is looking for better ways to treat stomach cancer that has spread. When cancer has spread, it's called 'advanced gastric cancer with metastases'. This particular study focuses on older patients.

The researchers want to compare two different treatment plans. One group of patients will receive a drug called ramucirumab (also known by its brand name, Cyramza) on its own. Another group will receive ramucirumab alongside another chemotherapy drug called paclitaxel. Both of these treatments are given into a vein, like a drip.

The main things the researchers want to find out are how long patients live after treatment and how their quality of life is four months into the study. They also want to understand any side effects, how well patients cope with daily activities, and their overall well-being.

Key takeaways

This study is for older patients with advanced stomach cancer.
It compares ramucirumab alone versus ramucirumab with paclitaxel.
The main goals are to improve survival and quality of life.
You would receive treatment as a drip and have regular health checks.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you might be eligible if you are an older patient who has been diagnosed with advanced stomach cancer that has spread to other parts of your body. Doctors sometimes call this 'stage IV stomach cancer with metastases'.

There are no specific age limits mentioned, so older adults of various ages may be considered. Both men and women can take part in this research.

Your doctors will carefully check your medical history and current health to make sure this study is right for you, and that it's safe for you to receive these treatments.

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.

Do I have advanced stomach cancer that has spread?
Am I considered an older patient?
Am I able to attend regular hospital visits for treatment and checks?
Am I willing to be assigned to one of two treatments by chance?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be randomly assigned to receive one of two treatment combinations: either ramucirumab alone or ramucirumab with paclitaxel. These treatments are given as drips, directly into a vein.

The study will involve regular visits to the hospital. During these visits, the research team will monitor your health, check for any side effects, and assess how the treatment is working. This will include blood tests, health checks, and questionnaires about your quality of life and how well you are managing everyday tasks. These assessments would happen regularly, for example, every two months for geriatric parameters and at specific times like four months for quality of life.

While the exact total duration for each person isn't given, the study will track your progress over several months, focusing on outcomes like survival at six months. You would continue to be monitored for a period to see the long-term effects of the treatment.

Potential risks and benefits

Taking part in a clinical trial like this can offer the potential benefit of accessing new treatments before they are widely available, which may help you live longer or improve your quality of life. However, there are also potential risks involved. The treatments, ramucirumab and paclitaxel, can have side effects, and the research team will closely monitor you for any problems. It's important to remember that you can stop taking part in 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 'advanced gastric cancer with metastases'?

This means stomach cancer that has spread from your stomach to other parts of your body.

What are ramucirumab and paclitaxel?

These are medicines used to treat cancer. Ramucirumab (Cyramza) is often given with other chemotherapy drugs like paclitaxel to help fight cancer.

How will the doctors know if the treatment is working?

They will monitor your health, perform tests, and ask you about your quality of life. They'll also look at how long people live after starting the treatment.

Will I get to choose which treatment I receive?

No, in this type of study, you would be randomly assigned to one of the treatment groups, like flipping a coin, to ensure a fair comparison.

What does a 'Phase II' study mean?

It means this is an earlier stage of drug testing. It's designed to see if a treatment is safe and effective enough to be studied in a larger way later on.