Clinical Trials Basics and Colorectal Cancer Treatment Planning

Cancer clinical trials are research studies where doctors investigate new treatments, procedures, or medical devices, to learn how safe & effective they may be in treating cancer. The goal is to show they are more safe & effective than currently existing treatments. Clinical trials are the last stage in the process of treatment development, and usually come after years of preclinical lab research.

The Importance of Cancer Clinical Trials

Cancer clinical trials help doctors to find new & better ways to prevent, diagnose, & treat cancer. Colorectal cancer (CRC) has only a few effective approved lines of therapy. Clinical trials help doctors develop the next generation of therapy so patients can have better outcomes. Trials offer patients a way to access treatments based on the latest research developments. These may potentially be better than existing options. Outcomes are better for patients who participate in trials compared to those who don’t!

The treatments your doctor is recommending to patients today were initially developed in clinical trials. Those trial participants helped pave a better path for everyone who came after. Well-conducted trials help advance understanding of cancers. Consequently, the NCCN and ASCO guidelines recommend patient participation in clinical trials at all stages of treatment!

Eligibility Criteria: Rules for Participation

Eligibility criteria are the set of rules that govern participation in clinical trials. Common eligibility criteria are disease type (CRC as an example), stage of disease, specific health parameters, & previous treatments received. Eligibility criteria group similar patients in a clinical trial, so scientific conclusions drawn are more likely to be accurate. For instance, an effective drug for KRAS wild-type (WT) mCRC patients may not work in KRAS mutant mCRC. Similar groups help find the true efficacy of a treatment.

These rules are defined by two main categories:

• Inclusion criteria: Must-have things to enroll in the trial; for example, the patient must have MSS colon adenocarcinoma.
• Exclusion criteria: Things the patient MUST NOT have to enroll in the trial; for example, the patient must not have brain mets.

It can be difficult to know whether you qualify for a clinical trial. Best to discuss your case with the trial coordinators to see if you are eligible now. If you are not eligible for one trial, try a different one and keep looking… Soon you may find one you qualify for!

Research Highlights and Currently Open Surveys

Research studies include the study of novel combinations of treatments to see if they work better, how they interact with each other, and if they are safe together. In the context of treatment planning for non-metastatic rectal cancer, there are special considerations. Clinical trials offer patients a way to access treatment based on the latest research and are especially helpful for patients who have progressed through standard-of-care (SOC) treatment.

Below is a summary of currently open surveys and research trials of interest to CRC patients & caregivers: