When considering a clinical trial, there are several considerations to discuss with your primary oncologist. This guide is designed primary for consideration of trials for refractory colorectal cancer, where standard of care therapies have been exhausted. When available, treatment in clinical trials earlier in the course of the disease should always be considered, and may have other considerations not reflected in the questions below.
The "logistic" questions
Will all patients get the new therapy? Is there a placebo? If yes, is there a mechanism for patients to receive the new therapy at a later point if they were initially randomized to the placebo or standard of care arm (called "crossover")?
How often to I have to come to the clinic? Some studies have time-intensive but important extra tests or physician visits in order to closely monitor the effects of the therapy. This may make it difficult to travel far from home to receive the therapy.
Can I take time off during therapy for vacation, travel, holidays? Some trials have different criteria for this, but is not common to have much flexibility on the schedule once the treatment is started.
How long after my last dose of chemotherapy until I can start? Typically 3 to 4 weeks, but sometimes longer for recent radiation therapy.
What are the costs that could be incurred by this? What is considered standard of care and billed to insurance? This may require talking to the billing or business center staff. Typically, office visits, routine blood work, and CT scans are considered standard of care, while all novel therapies or non-routine tests (EKGs, etc) are payed for by the trial.
How many patient have been treated with this regimen previously? Note that most oncologists won't have access to efficacy data from other sites or oncologists, so they aren't in a position to comment on how well this has worked in other patients.
What is the scientific rationale for this study? The oncologist should be able to provide a rationale for this particular therapy or combination.
The "hard" questions:
What impact do you expect this to have on my quality of life? This is another way to assess the anticipated side effects and how they impact your day-to-day function. Although this may be a goal of the treatment, it is unlikely that a clinical trial will improve your quality of life in the setting of refractory colorectal cancer.
What are the standard of care options (if any)? Consider also asking the tough questions about your anticipated life expectancy. While oncologists are historically poor at predicting this for an individual patient, it may help with deciding whether to invest the time and energy in a clinical trial and ensure that you and your oncologist are on the same page. Even if you got an estimate at the initial diagnosis, now is an important time to update expectations.
Do you think this is a good option for me? What would you do in my situation? Oncologists may provide clinical trial options in the setting of discussions about further treatment vs palliative care. Ask about any concerns or reservations your oncologist may have about whether a trial is the best fit for you.