Looking to the Horizon
When you're considering treatments for your metastatic colorectal cancer, you may have thought about clinical trials. Clinical trials are new ways that researchers are studying to find, treat, or even prevent cancer. Treatment trials test new types or dosages of treatments and are offered to people who have cancer.
For metastatic colorectal cancer, these trials aren't a last-ditch treatment effort. "They are often the best way to access tomorrow's treatments today," says Christopher Lieu, MD, medical scientific adviser for the Colorectal Cancer Alliance. He says one of his colleagues describes clinical trials as "reaching into the future for the best possible treatments."
Chemotherapy and other colorectal cancer treatments can be effective, but they aren't perfect. "Clinical trials offer you access to cutting-edge innovations, such as newer immunotherapies, personalized vaccines, or 'smart' drugs that target specific genetic mutations, years before they become widely available," says Lieu, who's also associate director for clinical research at the University of Colorado Cancer Center.
When you take part in a trial, you're often followed more closely than a typical patient. "You have an entire research team dedicated to monitoring your safety and progress," says Lieu. And your participation not only may benefit you, but it can help future cancer patients survive.
Current Clinical Trials for Metastatic Colorectal Cancer and Emerging Therapies
There are several areas where clinical trials currently are making progress.
Targeted therapies for "undruggable" targets. Until recently, mutation of the KRAS gene has been considered untreatable. But new trials have been testing KRAS inhibitors, specifically for G12C and G12D mutations. These drugs can "turn off the growth signals in these tumors," Lieu says. There are now two FDA-approved KRAS inhibitors available.
Combination immunotherapies. "While immunotherapy has been a home run for a small subset of patients (MSI-high), it hasn't worked well for the majority (MSS)," says Lieu. New clinical trials have been combining immunotherapy with other drugs to help the body's immune system find and fight colorectal cancer.
Antibody-drug conjugates (ADCs). These drugs combine chemotherapy and targeted therapy. "These are like 'smart bombs' that attach to cancer cells and deliver chemotherapy directly inside them, sparing healthy cells," says Lieu. "Drugs targeting specific receptors on colorectal cancer are showing very promising results in late-phase trials."
How to Know if You're a Good Candidate for a Clinical Trial
Whether or not you're a good candidate for a clinical trial depends on your specific cancer, as well as your own health. You must meet certain eligibility requirements, which can be different for each trial. They might include:
- Your cancer type and stage
- Specific biomarkers, which are gene mutations your body makes when you have cancer
- Previous and current treatments you've had
- Certain lab tests
- Medicine you're taking
- Any other medical issues you have
- Your activity level
You need to be healthy enough to take part in a clinical trial. Doctors use the ECOG Performance Status Scale to measure how cancer has an impact on your day-to-day life. It considers your daily activity and your physical abilities.
"If you are still able to walk, do light work, and care for yourself, you are likely a good clinical trial candidate," says Lieu. "If you have other uncontrolled medical issues, it might make qualifying harder."
Where do you find criteria and how can you learn more about trials?
You can find hundreds of thousands of private and public clinical trials in a searchable database at ClinicalTrials.gov. You search by condition and location and can find if a trial is still recruiting people. But because the database is so huge, finding suitable trials easily can be challenging.
Instead, you might want to start with an advocacy group, like the Colorectal Cancer Alliance. It has navigators who can help you refine results.
And it's always smart to reach out to your oncologist. "They may have a better sense of what trials are available locally," says Lieu. "Sometimes finding out more about clinical trials requires a second opinion, and please remember that it is always OK to get a second opinion!"
From extra tests to more attention, here's what to expect if you get into a clinical trial.
Visits and tests. If you get into a clinical trial, there are usually more visits, bloodwork, and other tests than you go through with standard care. Because safety is the priority, you'll be monitored more closely and more often.
Expenses. The sponsor of the trial – usually a drug company – typically pays for the drug itself and any extra tests. You'll continue to be billed for your regular doctor visits and standard tests.
Travel. If the trial isn't close to your home, you may have unexpected costs that aren't always covered. "Travel is a real consideration," says Lieu. "Some large trials offer a stipend to cover travel, parking, or hotels, but many do not." Be sure to ask the trial coordinator if travel expenses are reimbursed.
Benefits and risks. As with any treatment, you could improve, but there's no guarantee of success. "You get early access to potentially life-saving therapy and a high level of medical attention," says Lieu. "However, the new drug might cause unexpected side effects, or it might not work as well as the standard treatment."
Questions to Ask Before Starting a Clinical Trial
One of the big questions people ask when joining a clinical trial is the chance that you will receive a placebo. Placebos are treatments without any medical value. But there's little chance you will receive just a placebo in a cancer study. "You'll get standard treatment along with the treatment being tested. Placebos alone are rarely used in metastatic cancer without an active standard treatment alongside them," says Lieu.
Takeaways
Clinical trials can offer both benefits and risks, including access to cutting-edge treatments but also unknown side effects. They typically involve more visits and tests than standard treatment. You can find out more about clinical trials that might be a good fit by visiting the clinical trials database or by talking to your oncologist. Clinical trials for metastatic colorectal cancer are making progress with targeted therapies for some previously unresponsive mutations, as well as combination immunotherapies and antibody-drug conjugates.
Clinical Trial FAQs
Is there a chance I would get a placebo in a clinical trial?
Not likely. Clinical trials for cancer typically include giving standard treatment or the new treatment being tested.
Are clinical trials risky?
There's always a chance that treatment won't work or that side effects will increase. But there's also the chance that you'll receive a new treatment that will help.
What are clinical trial phases?
There are several phases for trials, depending on how much research has been done with a treatment. Phase 1 trials are testing a safe dosage, looking for side effects. Phase 2 tests the treatment with a larger group of patients. Phase 3 compares the treatment with more standard options.
Show Sources
Photo Credit: Cultura RF/Andrew Brookes/Medical Images
SOURCES:
Christopher Lieu, MD, medical scientific adviser, Colorectal Cancer Alliance; associate director for clinical research, University of Colorado Cancer Center.
NIH National Cancer Institute: "What Are Clinical Trials?"
Colorectal Cancer Alliance: "KRAS biomarker and colorectal cancer."
UCLA Health: "Combination of immunotherapy and targeted therapy improves survival for patients with advanced colorectal cancer."
Cleveland Clinic: "Antibody-Drug Conjugates (ADCs)."
American Cancer Society: "Things to Consider Before Taking Part in a Clinical Trial."
Target Cancer Foundation: "Biomarker Testing in Rare Cancers."
ECOG-ACRIN Cancer Research Group: "ECOG Performance Status Scale."
National Library of Medicine: "ClinicalTrials.gov."
CancerCare: "Clinical Trials: What You Need to Know."
LSU Health: "Before You Enroll: Questions to Ask About Any Clinical Trial."
Colorectal Cancer Alliance: "Clinical trials and colorectal cancer."
NIH Clinical Center: "FAQs About Clinical Studies."
