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Clinical Trials - GI Cancer

Clinical Trials

In Development

Open

In Follow-up

Completed

Endorsed Studies

Our research and clinical trials

Our research and clinical trials are not about laboratories and test tubes – they are about real people fighting disease and getting access to the most effective treatments.

Since 1991, our key priority has been to conduct research to find safe and effective treatments for GI cancers with the aim of improving medical practice and patient care. The challenges of treating GI cancers are vast so our research priorities and strategic activities focus our efforts to accelerate the pace of discovery.

Benefits of clinical trials for patients:

  • Give immediate access to the latest treatments
  • Change standard medical procedures 3 to 5 years earlier, if trials are in Australia
  • Improve cure rates and chances of surviving
  • Improve quality of life during treatment

We have clinical trials in various stages of progress: in development, open to patient recruitment, in follow up and completed.

Understanding Clinical Trial Stages

Phase I trials

They are usually small trials, recruiting only a few patients. The trial may be open to people with any type of cancer.

When laboratory testing shows that a new treatment might help treat cancer, phase I trials are done to find out

  • How much of the drug is safe to give
  • What the side effects are
  • How the body copes with the drug
  • If the treatment shrinks the cancer

Patients are recruited very slowly onto Phase I trials. So although they don’t recruit many patients they can take a long time to complete. The first few patients to take part (called a cohort or group) are given a very small dose of the drug. If all goes well, the next group have a slightly higher dose. The dose is gradually increased with each group. The researchers monitor the effect of the drug until they find the best dose to give. This is called a dose escalation study.

In a Phase I trial you may have lots of blood tests because the researchers look at how the drug affects you. They also look at how your body copes with, and gets rid of the drug. They record any side effects.

People taking part in Phase I trials often have advanced cancer. They have usually had all the treatment available to them. They may benefit from the new treatment in the trial but many won’t. Phase I trials aim to look at doses and side effects. This work has to be done first, before we can test the potential new treatment to see if it works.

Phase II trials

Not all treatments tested in a Phase I trial make it to a Phase II trial.  These trials may be for people who all have the same type of cancer or for people who have different types of cancer.

Phase II trials aim to find out

  • If the new treatment works well enough to test in a larger Phase III trial
  • Which types of cancer the treatment works for
  • More about side effects and how to manage them
  • More about the best dose to use

Although these treatments have been tested in Phase I trials, you may still have side effects that the doctors don’t know about. Drugs can affect people in different ways.

Phase II trials are often larger than Phase I. There may be up to 100 or so people taking part. Sometimes in a Phase II trial, a new treatment is compared with another treatment already in use, or with a dummy drug (placebo). If the results of Phase II trials show that a new treatment may be as good as existing treatment, or better, it then moves into Phase III.

Some Phase II trials are randomised. This means the researchers put the people taking part into treatment groups at random.

Phase III trials

These trials compare new treatments with the best currently available treatment (the standard treatment).  These trials may compare

  • A completely new treatment with the standard treatment
  • Different doses or ways of giving a standard treatment
  • A new way of giving radiotherapy with the standard way

Phase III trials usually involve many more patients than Phase I or II. This is because differences in success rates may be small. So, the trial needs many patients to be able to show the difference.

One example could be that 6 out of 100 more people (6%) get a remission with a new treatment compared to standard treatment. If there were 50 people in the new treatment group and 50 people in the standard treatment group, there may be 3 more people in remission in the new treatment group. The 2 groups would not look that different. But if the researchers gave each treatment to 5,000 people, there could be 300 more remissions in the new treatment group.

Sometimes Phase III trials involve thousands of patients in many different hospitals and even different countries. Most Phase III trials are randomised. This means the researchers put the people taking part into treatment groups at random.

Clinical trial centres

Click here to view and search for participating trial centres.

In addition to the Asia Pacific, we play a major role in clinical trial research internationally, working with researchers in the United Kingdom, Europe and North America.

Find out more about how we develop our research.


How you can help

One of our greatest challenges is lack of funding. Your support is vital in funding our research and continuing clinical trials, now and into the future. To show your support you can donate here or learn more about getting involved here.


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TRIAL TYPES EXPLAINED

Rare Cancers A rare cancer is defined as a type of cancer that has less than 6 incidences per year per 100,000 population.

Locally Advanced Larger cancers or tumours that have grown more deeply into nearby tissue. They may have also spread to lymph nodes but not to other parts of the body.

Early Stage A small cancer or tumour that is still located in the place it started and has not spread to nearby tissues. It also has not spread to the lymph nodes or other parts of the body. This stage of cancer is often highly curable, usually by removing the entire tumour with surgery.

Translational Research

Adjuvant/Neoadjuvant Neoadjuvant Therapy Treatment given as a first step to shrink a tumour before the main treatment, which is usually surgery, is given. Adjuvant Therapy Additional cancer treatment given after the primary treatment to lower the risk that the cancer will come back.

Advanced Disease Advanced disease (cancer) that has spread to other places in the body and usually cannot be cured or controlled with treatment.


Find out more about participating in a clinical trial

If you have any questions or think a clinical trial may be relevant to your situation, it’s important to ask your GP or oncologist. They can discuss the available options with you and have access to information about current trials and research.

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  • Home
  • About
    • About Us
      • Chair’s Message
      • Board of Directors
      • Staff Members
      • Governance
      • Employment Opportunities
      • Our impact
      • Annual Reports
      • Scientific Advisory Committee
      • Community Advisory Panel
      • International Development Committee
      • Translational Research Committee
      • New Zealand Committee
      • Research Operations Committee
      • Upper GI and Lower GI Working Parties
      • Corporate Support
  • GI Cancer
    • What is GI cancer?
      • Oesophageal Cancer
      • Liver Cancer
      • Stomach Cancer
      • Gallbladder & Biliary Tract Cancer
      • Pancreatic Cancer
      • Gastro-Intestinal Stromal Tumour (GIST)
      • Neuroendocrine Tumours (NETs)
      • Colorectal Cancer
      • Rectal Cancer
      • Small Bowel Cancer
      • Anal Cancer
    • Resources
      • Videos
      • Webinars
      • Cancer FAQ
      • Support Groups
      • Recommended Reading
      • Information Booklets
      • Recipes
      • Helpful Links
      • Newsletter Sign-up
    • News
      • Stories
    • Engage
      • Community Forums
  • Trials & Research
    • Clinical Trials
      • Trial Recruitment
      • Concepts – In Development
      • Trials – In Development
      • Trials – Open
      • Trials – In Follow-up
      • Trials – Completed
      • Trials – Substudies
      • Trials – Endorsed Studies
      • Participating Trial Centres
      • Clinical Trial FAQs
      • Genesis of a Clinical Trial
    • Research
      • Developing our Research
      • Research Priorities
      • Upper GI and Lower GI Working Parties
      • Idea Generation Workshop
      • Endorsed Study Model
      • Translational Research
      • Translational Research Model
      • Tele-Trial Model
      • Publications and Presentations
  • Health Professionals
    • AGITG
      • Become a Member
      • Member Spotlight
      • Our impact
      • Funding
    • Awards and Grants
      • Innovation Grant
      • Rectal Cancer Research Grant
      • Philanthropic Funding
      • Merck-AGITG Clinical Research Fellowship in GI Cancer
      • New Concepts Symposium
      • Best of Posters & Fast Forward
      • Outstanding Site Award
      • John Zalcberg OAM Award
      • Christine Aiken Memorial Award for Excellence in AGITG Study Coordination
      • AGITG Member Fundraiser of the Year Award
      • Grant Opportunities
      • Early Career Research Award for Excellence in AGITG Research
    • CommNETs
      • Presentations & Publications
      • Projects & Working Groups
      • Newsletters
      • Annual Research Workshop
      • CommNETs Committees
      • CommNETs Committee
      • Preceptorships
      • Policies
      • Contacts
    • News
      • Events & Education
        • Annual Scientific Meeting
  • ASM
  • Get Involved
    • The Gutsy Challenge
      • 2023 Gutsy Challenge Adventures
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      • Mt Himlung Himal Ascent – Nepal 2021
      • Past Gutsy Challenge Adventures
    • Fundraise
      • Start a Gutsy Fundraiser
      • Walk, Run or Ride for Research
      • Raise Your Fork for Research
      • Create Your Own Event
      • Workplace Fundraising Ideas
    • Donate
      • Where Does My Gift Go?
      • Make a Single Gift
      • Give a Monthly Gift
      • Direct Deposit Donation
      • A Gift In Your Will
      • Give In Memory
      • Workplace Giving
    • Volunteer
      • Corporate Support
  • Contact

GI Cancer Icon Changing outcomes for people with GIgastro-intestinal cancer since 1991

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