AG9601

A phase II feasibility study of pre-operative and post- operative chemotherapy using epirubicin, cisplatin and protracted venous infusion fluorouracil (ECF) in patients with advanced but operable gastric cancer.

General Community
Health Professionals

Trial Status

Completed

Cancer Type

Stomach Cancer

Aim

Surgery is the standard treatment for cancers of the stomach (gastric) and lower oesophagus (gullet) that can be removed with an operation, but the cancer often comes back (recurs) despite the best surgery. This trial will determine if adding chemotherapy two months before and two months after surgery improves recurrence and cure rates.

Trial Status

Completed

Cancer Type

Stomach Cancer

Publication Reference

Findlay M, Storey D, Gebski V, Hargreaves C, Cullingford G, Boyer M, Trotter J, Archer S, Davidson A, Johnston P, Yuen J, Dhillon H, Della-Fiorentina S, Richardson G, Truskett P, Goldstein D; on behalf of the AGITG. A pilot study of preoperative and postoperative chemotherapy in patients with operable gastric cancer: Australasian Gastrointestinal Trials Group Study 9601. Australian and New Zealand Journal of Surgery 2007; 77(4): 247–252.

Conference Presentation Reference

Cullingford G, Findlay M, Storey D, Boyer M, Trotter J, Archer S, Davidson A, Johnston P, Gebski V, Dhillon H. A phase II feasibility study of preoperative and postoperative chemotherapy (epirubicin, cisplatin and 4FU) in patients with advanced but operable gastric cancer. American Society of Clinical Oncology Annual Scientific Meeting; 18–21 May 2002; Orlando.

Aim

Principal Investigator

Professor Michael Findlay, Medical Oncologist, Auckland Hospital, NZ
Dr David Storey, Upper GI Surgeon, Royal Prince Alfred Hospital, NSW

Funding

Pharmacia Pty Limited (Australia)
NHMRC Clinical Trials Centre (Australia)

Stomach Cancer

Freqently Asked Questions

Is there any cost to take part in an AGITG trial?

No. Costs to participate in clinical trials are funded by the organisation conducting the clinical trial, usually with funding support received from government agencies such as the National Health and Medical Research Council (NHMRC) and Cancer Australia; or from untied sponsorship from the pharmaceutical industry; or from charitable funds raised by organisations such as the GI Cancer Institute and Cancer Council.

If I meet the trial’s selection criteria what happens next?

If after talking to your doctor you decide to participate in a clinical trial then the next step would be to provide your informed consent. Informed consent involves more than signing a form and will continue throughout the clinical trial.Informed consent is a process in which you learn the key facts about a clinical trial before you decide whether or not to participate. You’ll learn new facts during the clinical trial to help you decide whether or not to continue to participate. Feel free to ask questions to the Research Staff at any time before, during, or after the clinical trial.

It’s important that you understand the clinical trial as fully as you can, including how the treatments and tests in the study are different from tests and treatments outside of the clinical trial. The Research Staff should explain the possible risks and benefits of participating in the study and how it will be determined which ‘treatment group’ you’ll be in.

The information about the clinical trial should be given to you verbally (explained aloud) and in writing. You should be given enough opportunities to ask questions and seek advice from people you trust. You are the person who must decide what is enough time to ask questions and get advice from people you trust.

You have the right to ask for this information to be provided to you in a language other than English, if this will help you understand it completely.

There’s also a consent form which will look something like this.

How can I take part in a clinical trial?

When you are discussing treatment with your doctor, they may suggest that you participate in a clinical trial or tell you about a trial for which you would be eligible. If they do not, you can ask your doctor if there is a trial for which you would be eligible. Alternatively, you can find trials on the Australian Cancer Trials website and discuss their suitability with your doctor.

However, in some cases there will not be a trial available that you and your type of cancer would be eligible for, as trials are usually very specific. In addition, if you have certain health conditions such as a susceptibility to particular side effects, or if you are taking other medications, you may be ineligible for some clinical trials.

If you are eligible for a suitable trial, take time to reflect on the information, discuss things with family and friends, weigh up the pros and cons, and have further discussions with your doctor before you come to a decision.

What are the different phases in clinical trials?

Clinical trials are classified into one of three phases, each phase representing a different step in the testing of a new clinical treatment. Each step allows researchers to ask and answer important questions about the type of treatment and its effectiveness for patients.

Phase I trials determine the most appropriate way to give a new treatment. For example, should it be given by mouth, injected into the blood or injected into the muscle? These studies also evaluate what dose is safe and how often it should be used. A Phase I trial focuses on the safety of a treatment and generally involves only a small number of patients.

A Phase II trial determines how well a new treatment works. These trials test the safety of the treatment at a more advanced level than Phase I trials and evaluate the anti-cancer effect of the treatment.

Phase III trials are studies that compare a new treatment with current standard treatments. For example, a Phase III trial would evaluate whether a new drug is better than a drug that is currently being used to treat patients with the same condition. Similarly, a new surgical procedure may be investigated to determine whether it’s better than a surgical procedure that is the general standard of treatment. Phase III trials are only ever initiated if the results of Phase I and II trials show that the new treatment is safe and effective and likely to be as good as, or better than, the standard treatment. Phase III trials involve hundreds of patients, often from around the world.

Randomised control trials are where the treatment that a participant receives is chosen by random allocation (i.e. the decision about which treatment to give which patient is randomly selected, usually by computer). When a patient is ‘randomised’ it means that they have been randomly selected to receive either a particular treatment or intervention (i.e. a new drug) or placebo – a pill that contains no active ingredient.

What is randomisation?

If a trial involves more than one type of treatment, then a participant’s particular treatment is chosen for them randomly from the available trial treatments. This means that all patients on a trial are equally likely to receive the standard or the new treatment. If patients do not receive the new treatment they will receive the best standard available treatment; there will not be any control group that receives no treatment. Sometimes the participant will not know what particular treatment plan they are on and neither will their doctor. This is known as a double blind approach, in which any potential bias is minimised.

Are clinical trials safe?

No cancer treatment is guaranteed to be successful and most treatments have a number of side effects, and the treatments given in clinical trials are no exception. However, clinical trials must conform to a number of safety rules before they are approved by an independent ethics committee. Researchers must ensure that clinical trials are scientifically sound, that they do not produce more harm than good, that they keep patients informed of developments and results, and that they meet internationally agreed standards about the right way to carry out research involving people.

Before joining a trial, participants must be given accurate information about the study that outlines the purpose, all foreseeable benefits and risks (including side effects), full details of what is required of patients, and patients’ rights. Once all information about the trial is understood, the patient will sign a patient information and consent form. Most importantly, participants are free to opt out of the trial at any time for whatever reason, without any compromise to their future medical care.

What are the benefits of clinical trials to participants?

Clinical trials provide many benefits to participants. For example:

Patients who participate in clinical trials often receive immediate access to the latest treatments before they are made widely available to cancer patients.
The treatments offered on a clinical trial are either the best current standard therapy or therapy that is thought to be as good, or better, than the current standard therapy.
Some patients worry that they will receive no treatment if they are allocated to a control group, however all clinical trials are required to ensure that all patients receive at least the same level of treatment that would have been prescribed for them if they did not participate in the trial.
Patients involved in clinical trials receive an excellent standard of care, and are closely and regularly monitored by leading doctors, research nurses, and other medical experts.
Research shows that patients treated in clinical trials usually have greater cure rates and a better quality of life than those who are not involved.
Patients who take part in clinical trials play an active role in ensuring future cancer sufferers have access to the best medication.

Why are clinical trials important?

Clinical trials are necessary to find out if new treatments are more effective than those currently accepted as the best available standard therapy. Trials are also essential for new, improved treatments to be adopted, as all treatments and procedures must be scientifically proven before they can be made widely accessible. Furthermore, because not all people or cancer tumours are the same, clinical trials are needed in order to test how effective different types and/or combinations of treatments are for different people and tumours.

Additionally, conducting clinical trials in Australia means patients are able to access new treatments three to five years earlier than if they were conducted overseas.

Who runs clinical trials?

Clinical trials are run by teams of researchers at universities, hospitals and private institutions. The Australasian Gastro-Intestinal Trials Group (AGITG) coordinates most GI cancer trials in Australia and New Zealand. The AGITG has been conducting clinical trials for over 25 years and there are many doctors and research professionals who volunteer their time to conduct these trials. Each clinical trial has a Study Chair who is in charge of running the trial and a Principal Investigator (PI) from each institution taking part.

What are the different types of clinical trials?

Clinical trials can fall into several different categories, such as:

Prevention studies, which test how types of cancers can be prevented in people;
Detection studies, which test ways in which types of cancer are diagnosed, with the aim of increasing the chance of early diagnosis;
Treatment studies, which are conducted to find out which treatments are the most effective, and to test new treatments to see if they are more effective than existing standard treatments. Treatments tested can include drugs (chemotherapy) as well as radiotherapy, surgery, and complementary therapies;
Quality-of-life studies, which look for ways of improving the overall comfort of patients with cancer, and;
Cost-effectiveness studies, which compare new treatments with existing treatments in terms of costs, efficiency, and benefits.

What are clinical trials?

Clinical trials are scientific research studies involving patients. They are specifically designed to answer a particular question, which usually has to do with identifying new and/or better ways to detect, treat or prevent cancer.