Active not recruitingPHASE2INTERVENTIONAL

Planning Treatment for Oesophago-gastric Cancer: a Maintenance Therapy Trial

This study, for people with stomach or gullet cancer that has spread or is advanced, is trying to find better ways to manage the disease after initial chemotherapy. Patients will first receive standard chemotherapy. Then, depending on the type of their cancer (HER-2 positive or negative), they might receive a new maintenance treatment or be closely monitored. The aim is to see if these 'maintenance' treatments can stop the cancer from growing for longer. It's an important step in finding more ways to help people live better with this type of cancer.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

Royal Marsden NHS Foundation Trust

Enrolment target

494

Start

01 Feb 2015

Estimated completion

01 Jun 2027

Adenocarcinoma of the Oesophagus Adenocarcinoma of the Gastro-oesophageal Junction Adenocarcinoma of the Stomach

What is this study about?

This study is about people who have advanced cancer of the gullet (oesophagus) or stomach. When we say 'advanced', it means the cancer has either spread to other parts of the body (metastatic) or is too large to be fully removed by surgery (locally advanced). First, patients in this study will receive the usual chemotherapy treatment that doctors recommend for their type of cancer. This is called 'first-line chemotherapy' and helps to shrink the cancer or stop it from growing.

After completing this initial chemotherapy, if the treatment has worked well and the cancer is stable or has shrunk, the study will explore what comes next. Some patients will continue with a medicine designed to keep the cancer under control, known as 'maintenance therapy'. Others will be closely monitored by their doctors. The main goal is to see if these maintenance treatments can help people live longer without their cancer growing again, compared to just being monitored.

The study is split into groups based on a specific characteristic of the cancer called 'HER-2 status'. Some cancers have a lot of HER-2 protein (HER-2 positive), and others don't (HER-2 negative). This helps doctors decide which treatments might work best. By carefully comparing different approaches, researchers hope to find better ways to manage stomach and gullet cancer in the long term.

Key takeaways

This study explores new treatments for advanced gullet or stomach cancer.
It focuses on 'maintenance therapy' after initial chemotherapy.
Participation involves either a new drug or close monitoring.
The goal is to stop cancer growth for longer.
You'll have regular medical check-ups and support.
Your HER-2 status helps guide your treatment path in the study.

Who may be eligible?

This study is for adults aged 18 or over who have advanced gullet or stomach cancer that can't be operated on. To join, you must have already finished about 18 weeks of your first course of chemotherapy, and that treatment must have successfully kept your cancer stable or made it shrink. Your doctors will also check if your cancer still can't be removed by surgery and cannot be completely treated with other types of radiation.

It's important that your overall health is good enough to take part. This means your blood tests for things like blood cells, kidney function, and liver function need to be within a healthy range. Researchers will also need a small piece of your cancer tissue that was taken during diagnosis to learn more about your cancer and help guide future treatments.

If you've had chemotherapy or radiotherapy for cancer that wasn't metastatic in the past, it needs to have been at least six months ago. You also shouldn't have had radiation therapy for your advanced cancer before, though there might be exceptions your doctor can discuss with the study team.

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 gullet or stomach cancer that can't be surgically removed?
Have you finished about 18 weeks of initial chemotherapy, and your cancer is stable or has shrunk?
Is your general health, including blood tests, good enough for a study?
Do you have a small tissue sample from your cancer available for tests?

Answer every question to see your result.

What does participation involve?

If you join this study, you will first complete your standard chemotherapy (around 18 weeks). Once that's done and if your cancer is stable, you might then be given a maintenance medicine or be closely watched, depending on your cancer type and a random decision. If you receive a maintenance medicine, you'll take it regularly according to the study plan. If you are in the monitoring group, you will have regular check-ups.

Throughout the study, you will have regular visits to the hospital for checks, scans, and blood tests to see how you are doing and how the treatment is affecting you. These visits will happen every few weeks. The exact duration of your participation will vary, but you'll be followed closely for a period to see the long-term effects of the treatments or monitoring. Your doctor and the study team will explain everything in detail.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as receiving a new maintenance treatment that might help keep your cancer under control for longer than standard care. You will also receive very close medical monitoring. However, there are also potential risks; any treatment can have side effects, and some might be serious. The new medicines are not guaranteed to work for everyone, and sometimes they don't work as well as hoped, or they might cause new problems. Your doctor will discuss all known side effects and help you understand them. Remember, you have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (1)

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

The Royal Marsden NHS Foundation Trust, Downs Road, Sutton
Verified postcode
Sutton, United Kingdom

Common questions

What is 'maintenance therapy'?

Maintenance therapy is treatment given after initial chemotherapy. It's meant to keep the cancer stable and prevent it from growing back or spreading for as long as possible.

What does 'HER-2 positive' or 'HER-2 negative' mean?

HER-2 is a protein that can be found on cancer cells. Knowing if your cancer is HER-2 positive or negative helps doctors choose treatments that are more likely to work for you.

Will I definitely get a new medicine if I join?

Not necessarily. If your cancer is HER-2 negative, you might receive a new medicine or be closely monitored, chosen randomly. If it's HER-2 positive, you'll receive a standard maintenance medicine.

How long will I be in the study?

The study involves completing your initial 18 weeks of chemotherapy first. After that, your participation in the maintenance or monitoring phase will continue as long as the treatment is working and you are tolerating it well, or until your doctor decides otherwise.

Can I leave the study at any time?

Yes, you are free to leave the study at any point without needing to give a reason. Your decision will not affect the medical care you receive.