Should I Join a Clinical Trial? A Guide for Bowel Cancer Patients

Making decisions after a bowel cancer diagnosis can be overwhelming, especially when you’re presented with unfamiliar terms and options. One of those might be the opportunity to take part in a clinical trial. If you’re living with early-onset bowel cancer in Australia, you may be wondering if this is something you should seriously consider.

Here’s a comprehensive guide to help you understand what clinical trials are, what they involve, and how to work out whether joining one is the right step for you.

What Is a Clinical Trial?

Clinical trials are research studies involving people. They aim to discover better ways to prevent, diagnose, treat or manage diseases like cancer. Every treatment that’s standard practice today was once tested in a clinical trial.

In Australia, clinical trials are conducted under strict ethical and scientific guidelines, regulated by organisations like the Therapeutic Goods Administration (TGA) and the National Health and Medical Research Council (NHMRC).

There are four main phases:

• Phase 1: Focuses on safety, dosage, and side effects in a small group of people.
• Phase 2: Explores effectiveness and further safety in a larger group.
• Phase 3: Compares the new treatment to the current standard treatment across an even larger group.
• Phase 4: Conducted after the treatment is approved, monitoring long-term outcomes and effects.

Why Consider a Clinical Trial?

Clinical trials are not only for those who have exhausted all other treatment options. In fact, they’re often designed for patients at various stages of diagnosis and treatment. Here’s why you might consider participating:

• Access to cutting-edge treatments before they are widely available.
• Closer monitoring and care through more frequent appointments, scans, and tests.
• A chance to contribute to research that may help future patients with early-onset bowel cancer.
• Potential for improved outcomes if the new treatment proves more effective than the standard one.

Key Questions to Ask Before Joining

Before enrolling in a clinical trial, it’s important to gather detailed information. Here are some essential questions to ask your oncologist or the trial coordinator:

• What is the purpose of this trial?
• How does it differ from my current treatment plan?
• What are the known risks and possible side effects?
• How often will I need to visit the hospital or clinic?
• Will I need to travel? If so, are travel or accommodation costs covered?
• What happens if the treatment doesn’t work for me?
• Can I leave the trial at any time?

Types of Trials Relevant to Bowel Cancer

There are several types of clinical trials that may be suitable depending on your stage, subtype, or genetic profile:

• Treatment trials: Testing new chemotherapy drugs, targeted therapies, immunotherapy, or radiation approaches.
• Supportive care trials: Exploring ways to reduce side effects like nausea, fatigue, or peripheral neuropathy.
• Genomic or biomarker-based trials: Investigating how your unique tumour biology responds to personalised therapies.
• Prevention trials: Sometimes available if you are at high risk due to family history or hereditary conditions like Lynch syndrome.
• Quality of life studies: Designed to improve physical, emotional, or social well-being for patients in treatment or recovery.

Who Can Join a Clinical Trial?

Every trial has a set of criteria that determines who can participate. These are known as inclusion and exclusion criteria. They may include factors such as:

• Age and sex
• Type and stage of bowel cancer
• Previous treatments received
• General health and organ function
• Genetic mutations or biomarkers present (e.g. KRAS, BRAF, MSI status)

Being eligible doesn’t mean you have to participate, but it opens the door to a potentially valuable option.

How to Find a Clinical Trial in Australia

There are several ways to search for bowel cancer clinical trials available in Australia:

• TrialScreen.org is the world’s leading free search engine for actively recruiting clinical trials around the globe.
• ClinicalTrials.gov is a global registry of clinical studies.
• Australian Cancer Trials (inactive at time of writing) lets you search based on cancer type, location, and keywords.
• Your oncologist or multidisciplinary team can recommend suitable trials based on your diagnosis and treatment history.
• Cancer Council 13 11 20 offers guidance on navigating the process and understanding your rights and responsibilities.

Things to Consider Before Saying Yes

Choosing to enrol in a clinical trial is a personal decision, and it’s not always the right choice for everyone. Here are a few points to weigh:

• Time commitment: Some trials require frequent appointments, blood tests, imaging, or questionnaires.
• Travel and logistics: If the trial is conducted interstate or in a major city, it may require time away from home, family, or work.
• Emotional impact: There may be unknowns, including whether the treatment will work, or if you’ll be receiving the placebo in a blinded trial.
• Potential side effects: New therapies may carry different or unexpected risks.
• Impact on future treatment: Participating in a trial may delay or limit your eligibility for other treatment options.

Your Rights as a Participant

If you decide to take part in a clinical trial, it’s important to know that you have rights protected by law and ethics guidelines:

• Informed consent: You must be given a clear explanation of the trial, its risks, and what’s expected of you before agreeing to participate.
• Voluntary participation: You can leave the trial at any point without affecting your standard care.
• Privacy and confidentiality: Your health information will be protected under Australian privacy laws.
• Access to care: Even if you’re not receiving the trial drug, you’ll receive the current best-practice treatment for your condition.

Real-World Examples of Trial Benefits

Recent Australian trials have explored:

• Immunotherapy for MSI-high metastatic bowel cancer, with some patients experiencing durable remission.
• Circulating tumour DNA (ctDNA) monitoring, which could help determine whether patients need adjuvant chemotherapy after surgery.
• New targeted agents that may help those with rare mutations like BRAF V600E.

Breakthroughs from these trials are changing the landscape for people with early-onset bowel cancer, offering hope, especially for those who don’t respond to traditional therapies.

Financial and Emotional Support

Joining a clinical trial can come with extra stress or financial strain. Fortunately, several organisations offer support:

• Bowel Cancer Australia provides a dedicated Bowel Care Nurse service and links to trial resources.
• Cancer Council offers financial, legal, and emotional support services, including free telephone counselling.
• Hospital social workers or clinical trial coordinators can help with logistics, funding queries, and connecting with peer support networks.

Final Thoughts: Is It Right for You?

There’s no “one-size-fits-all” answer when it comes to clinical trials. It depends on your diagnosis, personal circumstances, and your treatment goals. Some people find great comfort and hope in joining a trial, while others prefer to stick with established treatment paths.

Speak openly with your treating team, and don’t hesitate to get a second opinion if you’re unsure. If you do choose to participate, know that your contribution could help shape the future of bowel cancer care, for yourself and for many others to come.