What do I need to know about my cancer before researching trials?
Trials are sometimes thought of as a last resort — but this isn’t true! Doctors often want to complete standard-of-care (SOC) treatments before moving on to clinical trials. But if you feel empowered and are educated on clinical trials, you can find trials that complement existing standard-of-care treatments.
In order to find trials that may be an option for you, there are several pieces of information you must know about your cancer and any treatments you have already had. If you don’t already know the answers, we’ll help you find out!
First of all, if you are newly diagnosed or want a good place to start with understanding colorectal cancer, check out “The Basics” section of CRC101.
You can also learn more about standard-of-care by reading these Patient Guides from the National Comprehensive Cancer Network (NCCN).
Know yourself
It’s important that you know yourself, your goals, and your risk tolerance before you start searching for trials. Think about your treatment goals — more time with family and friends, a chemo break, disease stability, or whatever else is important to you!
It’s also a good idea to think about your risk tolerance. Some people are comfortable with larger unknowns, and other people feel better with fewer unknown factors. What are you willing to forgo to be part of a trial? What are your trial dealbreakers? What feels right for you?
You should take your personal and financial circumstances into consideration as well. Are you willing to travel if you have young kids? Can you take time off work to attend a trial? These considerations will help guide your trial decision-making.
There is no “perfect” clinical trial. Only you can figure out what you need, so when you have options ready to go, you are ready to figure out what works for you.
Know your disease
What stage is your cancer?
Check out our CRC101 section on cancer staging. You can also learn more about staging from the American Cancer Society. Know the size and locations of your current tumors, if any. Some trials have requirements, such as a minimum size of measurable disease or exclude certain metastases.
Is your cancer MSS or MSI-H?
All newly-diagnosed colorectal cancer patients should be tested for MSS/MSI-H status. This is important information that your doctor should be able to tell you. To learn more about what this means and why it’s so important, check out our CRC101 section on MSS vs MSI-H.
What treatments have you already had?
Make sure you have a list of any treatments you’ve had — specific chemotherapy drugs, surgeries, radiation treatments — along with a basic timeline of when you received them. To help you get started, here’s a description of common cancer treatments from the American Society for Clinical Oncology.
Tumor genomic profile
Your tumor may be tested for genetic mutations that impact what treatments and trials are options for you. This testing may have been done when you were first diagnosed, and can be repeated after treatment. Check out our biomarker section in CRC101 for more information on this topic.
Health status
Trials often have eligibility requirements for how “healthy” you are. Knowing your recent blood test results and other markers of health can be very helpful. They may use measures like the ECOG scale to gauge your physical ability levels. Trials may also have exclusions based on other conditions like HIV, autoimmune diseases and other cancers.
Want to learn more about your personal and medical goals?
This Clinical Trial Assessment print-out worksheet is a great first step. It can help you think through your personal goals and organize all your medical information.
When you’re done with this assessment, have your carepartner complete it too. Some people have found it very helpful to complete the assessment separately and then compare the answers. Even couples who have been married for decades have learned a lot about their partner’s perspective and priorities by doing this!
So why does all of this matter?
Most clinical trials have eligibility criteria — a list of rules that determine which patients can and cannot participate. These criteria often include stage of cancer, prior treatments, etc. Requirements help make sure that participants in a trial are standardized enough to get reliable results from the research. When all participants meet the same eligibility criteria, it is more likely that the results of the study are caused by the intervention being tested, and not by other factors or chance.
Know the standard of care for your stage
Standard of care (SOC) treatment is outlined in the National Comprehensive Cancer Network (NCCN) guidelines. Along with personal knowledge and experience, oncologists use the NCCN guidelines to make treatment decisions for patients. These guidelines offer a standard framework for cancer treatment depending on your stage. Knowing what SOC treatments entail will help you gauge whether a specific trial is a good fit for you.
You can talk to your doctor about SOC treatment. Ask questions like “What is the most likely outcome I can expect for the line of treatment I am on?” and “What is the next step when that treatment is complete?”
Know how trials work in your area
There are a lot of factors that can affect the process of finding clinical trials. Trials work differently depending on what country you live in. In addition, your care team’s familiarity with trials may vary.
There are trials that are run globally, nationally, and in the US, local to your cancer center. Even within a country, trial access can vary — NCI cancer centers may do many trials, but community clinics may have fewer options. Familiarity with the trial landscape will depend on where your doctor practices.
If your oncologist tells you “there are no trials available,” it may simply mean there are no trials currently relevant to you at your cancer center, or trials that your doc is immediately involved in — not that there are no trials available anywhere.
Patient perspective by Julie
In general, when it comes to treatment response, ORR (overall response rate) is the focus of clinical trial conclusions. This includes partial and complete responses. It doesn’t include stable disease (SD). While I want researchers to continue to push for high ORR, as an individual patient, I think it undervalues stable disease, particularly for Stage 4 patients. And I admit I get frustrated when I hear ‘trash talk’ about there being ‘no good trials’ because there aren’t miraculous cures. Including potential stable disease in my assessment of trials makes me more encouraged by more trials as options. A treatment with high potential for stable disease might not be the final answer, but it can be an invaluable leg in a successful race. Of course, it depends on one’s individual situation and treatment goals. So, while in my clinical trials results I will just be counted as a data point with a pretty irrelevant stable disease, I wanted to share what being stable on a clinical trial for 16 months (and hopefully more) has done for me personally.
I joined the trial as a stage 4 colon cancer patient with approximately 11 lung mets (with prior extensive liver and bone mets). I have no currently targetable mutations. My tumors were pretty rapidly progressing on my third line of chemo (after a few rechallenged as well) and I did not have local treatment options at the time. I also had a vague, unmeasurable, previously treated area of concern in my humerus (arm bone). I knew that the trial combo in other contexts had low ORR but high short-to-mid term stability. Many discouraged me from participating because of the low ORR, but stabilizing my disease with a short chemo break so I could find a next treatment was compelling for me. My time on the trial has well outlasted that short window, but it is still delivering on these same initial wishes with some additional surprises.
My results to date have been stable disease clinically. My targeted tumors (the two they measure per the standard RECIST 1.1 criteria) cumulatively shrank by 29.6% at the lowest and the rest of my lung tumors either disappeared, died, or shrank considerably. While the cause is still unclear, there is damage to my humerus implying tumor activity there.
The positive impact of the trial beyond being ‘stable’:
- Significantly improved quality of life! It has given my body an extended break from cumulative chemo toxicities — I’m working out more regularly, eating more freely (and therefore more healthfully). I am much better day-to-day than previously — in terms of daily activity as well as an easier treatment schedule.
- I’ve had a much lower cost of treatment — I didn’t hit my deductible until July when it has been Feb at the latest.
- Significantly expanded my future treatment options. It has opened up future systemic treatment options, like rechallenge of chemo. It has made local treatment options viable (ie, surgery + ablative). It has given time for additional trials to open up. It’s improved my chances for future trial inclusion – for instance, previously my platelets barely met the 100 threshold which is a requirement to participate on many trials and now, while still not normal, they are consistently above that making future trial qualification more likely.
While I still would love to get a complete response, stable disease on this trial has been a big win for me during my time on it as well as its role in my overall treatment strategy. My hopes in sharing this personal experience are to reduce aversion to STABLE DISEASE and to encourage thinking about trial options more holistically and how they might align with your specific goals vs the broad statistics that researchers are (and should be) interested in. In your case, the idea of stable disease may or may not play a role, but it’s something that’s likely counter to how clinical trials are conducted/communicated from the research point of view. That is because research is inherently not about an individual but what’s best for a group.
Focus on identifying what you care about and then use that to understand how a trial might fit into those goals. It’s like if you are a vegetarian and you go to a restaurant and the most popular item on the menu is a ‘steak’ and it’s featured everywhere on the menu, will you order the steak? No, you will look past the steak and find a much better meal suited for you.
Want to learn more about clinical trials?
Join one of our COLONTOWN Facebook groups:
- In Tom’s MSI-H Clinic, we discuss treatments and trials for MSI-H patients
- In Tom’s MSS Clinical Trials, we chat about trials open to MSS patients
- Tom’s NIH Lounge is used to talk about trials run by the National Institute of Health (NIH)
- Check out Across the Pond where you can find information on treatment in Europe
Want to join? Fill out the registration form here.
COLONTOWN University has so much more to offer, from DocTalk videos with CRC experts to easy-to-understand biomarker test breakdowns. We’re here for you! See our list of Learning Centers here.