Clinical Trials for Colon Cancer

In In The News by Barbara Jacoby

By: Kathleen Hall


Are you currently undergoing treatment for colon cancer? If so, you should know that any drug your doctor prescribed went through rigorous testing and evaluation before it became widely available to patients. After a drug shows significant potential in the lab, researchers study it in clinical trials.

There are three phases of clinical trials: Early phase trials (phases I and II) help researchers determine if a potential treatment has benefits, and if so, at what dose and for which patients. If the treatment still shows promise, phase III trials compare the new treatment to the current standard of care (treatment that is widely accepted as the best care for a certain disease) with a large group of participants.

Patients should always inquire about participating in an appropriate clinical trial, says Dr. Vamsidhar Velcheti, staff physician of hematology and oncology and associate director at the Center for Immuno-Oncology Research at Cleveland Clinic.

Benefits of Clinical Trials

The No. 1 benefit of participating in such research is that a new treatment may be more effective than the current standard of care. If that’s the case, you’ll be among the first patients to benefit from it.

Unfortunately, there are misconceptions that researchers use patients as guinea pigs when they participate in medical studies. “This is really not true,” Velcheti says. Patients who have advanced stage colorectal cancer always get the best treatment in this kind of research, and every study has strict ethical standards in place to protect patients.

“Patients in clinical trials have more options,” says Dr. Sreeram Maddipatla, medical oncologist/hematologist for the Liver Center and Pancreas Center at UF Health Cancer Center – Orlando Health. If you have stage 4 colorectal cancer (the most advanced disease), participating in a clinical trial may increase the number of years you could live. “You could have options that are not [Food and Drug Administration]-approved, but patients [in clinical trials] have access before approval. This could add months, years, to your lifespan.”

Some patients also appreciate the opportunity to take a proactive role in their own health care and to know their participation may help other colorectal cancer patients down the road.

Downsides of Clinical Trials

Just because a drug is in clinical trial doesn’t mean it’s better than the standard colon cancer treatments available. “The treatment may not live up to expectations,” Maddipatla says. The treatment may also have unexpected side effects. Furthermore, even if the new therapy is beneficial for some patients, it might not help you.

Participating in a clinical trial may be a bit cumbersome for patients who live in small towns, far from large medical institutions that are more likely to conduct such research, Maddipatla says. You may need to invest more time and travel commitment. Insurance companies don’t always cover all the costs related to the study (for example, extra tests). Fortunately, Maddipatla says, patients can often find funding help through charities, support groups and drug companies who sponsor some clinical trials.

Every clinical trial has a strict set of guidelines and criteria about who can and cannot participate. These criteria protect patients and ensure the study produces results that will help clinicians make the best treatment recommendations. A protocol, or recipe of sorts, outlines exactly what will happen in the research, and a scientific review panel of experts and an Institutional Review Board (an ethics panel) oversees all clinical trials. You are free to leave the research at any time.

Most clinical trials focus on disease treatment, although you can also participate in trials for cancer screening, prevention and quality of life/palliative care. You can find lists of clinical trials at, a registry and results database of publicly and privately supported clinical trials, or search for colorectal cancer trials at the National Cancer Institute’s website.

Clinical Trials Have Improved Colon Cancer Treatments

The biggest recent advancements in colon cancer treatment have come in the area of immunotherapy, which uses your immune system to fight cancer. In fact, colorectal is the top cancer type for which immunotherapy is being evaluated, according to The Cancer Research Institute. To date, the FDA has approved four immunotherapy drugs for colorectal cancer, and there are many small and large clinical trials underway.

“Patients with stage 4 of CRC who have a genetic mutation called Microsatellite Instability can automatically enroll in a clinical trial testing immunotherapy,” Maddipatla says. “We know immunotherapy works, but less than 5 percent of [colorectal cancer] patients have this mutation. What about other patients who don’t have this mutation? Can they benefit as well?” Clinical trials will help oncologists find answers to this important question, as well as others.

Ask your doctor about participating in a clinical trial. You have nothing to lose by getting more information, Maddipatla says.