Active not recruitingPHASE2, PHASE3INTERVENTIONAL

Trial of Preoperative Therapy for Gastric and Esophagogastric Junction Adenocarcinoma

This study aims to find the best way to treat stomach cancer (also called gastric cancer) that can be removed by surgery. Stomach cancer is a serious illness, and while surgery is often the best treatment, doctors are always looking for ways to improve patient outcomes. Researchers are comparing two treatment plans. One group of patients will receive chemotherapy before surgery. The other group will receive both chemotherapy and radiotherapy before surgery. All patients will then have their surgery and further chemotherapy afterwards. By comparing these two approaches, the study hopes to find out which method leads to better long-term survival and more successful removal of the cancer.

At a glance

Status

Active not recruiting

Phase

PHASE2, PHASE3

Sponsor

Australasian Gastro-Intestinal Trials Group

Enrolment target

574

Start

01 Sep 2009

Estimated completion

31 Dec 2026

Gastric Cancer

What is this study about?

Stomach cancer, or gastric cancer, is a serious disease that affects many people worldwide. Although treatments have improved, doctors are still working hard to find even better ways to fight it. For many patients, surgery is a key part of treatment to remove the cancer. However, sometimes the cancer can return, or it might not be completely removed.

This study, called TOPGEAR, is particularly interested in improving treatment for stomach cancer that can be safely removed by an operation. The main idea is to see if adding radiotherapy to chemotherapy *before* surgery makes a difference. Researchers want to know if this combination can shrink the tumour more effectively, making the surgery even more successful and ultimately helping patients live longer.

Patients taking part will be put into one of two groups by chance – like flipping a coin. One group will get chemotherapy before their operation, and the other group will get both chemotherapy and radiotherapy before their operation. Everyone will then have surgery and some more chemotherapy afterwards. The study will carefully follow these patients for five years to see how they respond to the treatments.

Key takeaways

This study is for stomach cancer that can be removed by surgery.
It compares chemotherapy alone versus chemotherapy plus radiotherapy before surgery.
All patients will have surgery and further chemotherapy after.
The goal is to find out which approach leads to better survival.
Participation involves ongoing monitoring for five years.

Who may be eligible?

To be able to join this study, your stomach cancer must be a certain type (adenocarcinoma) and at a stage where doctors believe it can be successfully removed by surgery. This means the cancer shouldn't have spread to other parts of your body, and your surgeon should be confident they can remove it all.

You also need to be at least 18 years old and generally in good health, meaning you can carry out most normal daily activities without much trouble. Your body's organs, like your heart, kidneys, and liver, need to be working well enough to handle the treatments.

There are also reasons why you might *not* be able to join. For example, if your cancer has already spread to distant parts of your body, or if you've already had chemotherapy or radiotherapy for cancer, this study might not be suitable for you. If you are pregnant or could become pregnant, you would need to agree to use effective contraception.

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 you have a specific type of stomach or gastroesophageal junction cancer?
Has your doctor said your cancer might be able to be fully removed with surgery?
Are you 18 years old or older?
Are you generally feeling well enough to carry out daily activities?
Have you not had cancer treatment like chemotherapy or radiotherapy before for this cancer?
Does your cancer not appear to have spread to other distant parts of your body?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first be randomly assigned to one of two groups. One group will receive chemotherapy before their surgery, while the other group will receive both chemotherapy and radiotherapy before surgery. The specific chemotherapy drugs you might receive include combinations like Epirubicin, Cisplatin, and 5-Fluorouracil, or others containing Capecitabine or Oxaliplatin. The radiotherapy will involve precise radiation aimed at the cancer area.

After this initial treatment, you will have your surgery to remove the stomach cancer. Following your surgery, you will receive more chemotherapy. Throughout the study, you will have regular visits for check-ups, tests, and scans to monitor your health and how the treatment is working. Doctors will follow your progress closely for five years after your treatment ends to see the long-term effects.

Potential risks and benefits

Taking part in this study could potentially offer you access to treatments that might improve the outcome of your stomach cancer compared to standard care, especially if the combination of chemotherapy and radiotherapy proves more effective. However, all treatments for cancer carry risks and side effects, and chemotherapy and radiotherapy can cause tiredness, sickness, and other issues. There is no guarantee that the treatment will be successful for you. It's important to remember that joining a study is a completely voluntary decision, and you can withdraw from the study at any time without it affecting your medical care.

Locations (59)

Calvary Mater Newcastle
Verified postcode
Newcastle, Australia
Chris O Brien Lifehouse
Verified postcode
Sydney, Australia
Liverpool Hospital
Verified postcode
Sydney, Australia
Nepean Hospital
Verified postcode
Sydney, Australia
Prince of Wales Hospital
Verified postcode
Sydney, Australia
Royal North Shore Hospital
Verified postcode
Sydney, Australia
St George Hospital
Verified postcode
Sydney, Australia
Westmead Hospital
Verified postcode
Sydney, Australia
The Tweed Hospital
Verified postcode
Tweed Heads, Australia
Wollongong Hospital
Verified postcode
Wollongong, Australia
Princess Alexandra Hospital
Verified postcode
Brisbane, Australia
Flinders Medical Centre
Verified postcode
Adelaide, Australia

Common questions

What is 'neoadjuvant therapy'?

It means getting treatment like chemotherapy or radiotherapy *before* surgery to try and shrink the tumour.

What is the difference between Phase 2 and Phase 3?

Phase 2 studies check if a new treatment is safe and works. Phase 3 studies compare a new treatment with the best existing one to see if it's better overall.

Will I know which treatment group I'm in?

Yes, you will know if you are receiving chemotherapy alone or chemotherapy with radiotherapy before surgery.

How long will I be followed after treatment?

You will be followed up by the study team for five years after your treatment has finished.

What if I change my mind about participating?

You can withdraw from the study at any time, for any reason, without it affecting your usual medical care.