When Should I do a Clinical Trial? By Dr. Laura Porter
January 1, 2019
An important question to ask regarding clinical trials is when is it appropriate to look for clinical trials? The short answer is immediately, and I will tell you why.
Less than 3% of people with cancer participate in clinical. Not only is this a result of misconceptions but also what is required from the clinical trials sites. Many people see clinical trials as a last-ditch effort, but this is not the truth. Most clinical trials for colorectal cancer require that you have failed or progressed on the first two lines of standard of care treatment, including irinotecan and oxaliplatin, but they also require that you have an ECOG Performance Status of 0-2 (see chart).
I have worked with clinical trials in several capacities since 2004. I worked with the Colon Cancer Alliance in developing their first clinical trials helpline and the site that they currently use. For the Moonshot program, I developed a list of trials from Clinicaltrials.gov that I felt were important in colorectal cancer. I have looked at clinical trials that people have found and deciphered the criteria for enrollment. With all this experience, I was surprised to learn that some of my beliefs about clinical trials were not true.
I was asked to help a young woman find clinical trials before she would need them. She was 38 and had been diagnosed with 20+ liver metastases and 10+ lung metastases four months after the birth of her first baby. I started with Clinicaltrials.gov and her tumor profile. She had been on FOLFOXIRI and had to stop Oxaliplatin and then eventually irinotecan. The initial list was 65+ trials which I narrowed down over the weeks to ten. I called several sites, and they were extremely helpful and encouraging. While my friend was only on 5-FU, she had progression and was hospitalized several times. NIH (National Institutes of Health) was set to enroll her into a trial until I mentioned that she was on oxygen. The trial coordinator told me that she needs to have Performance Status of 1 but not less than 2. Unfortunately, she did not.
I was intrigued, and I looked up the other trials. They all required between 0 and 2 on the ECOG performance scale. That is when it hit me. To get into clinical trials you must be relatively healthy, clinical trials cannot be a last-ditch effort, and you may not be healthy enough if you wait too long. This was not the case with my friend. She was willing to go into a trial, but she progressed too quickly. We first spoke in June and she passed away in September.
Her death has inspired me to talk about clinical trials in a rational, informed manner. There are many trials out there for the new immunotherapy or immuno-oncology drugs, but they are not without significant risks. There are other trials that are looking at combining existing treatments to find a combination that may work. The decision to go into a clinical trial should be one that is well informed with the possible risks and possible benefits.
There are certain things that you can do when first diagnosed with metastatic colorectal cancer
I have worked with clinical trials in several capacities since 2004. I worked with the Colon Cancer Alliance in developing their first clinical trials helpline and the site that they currently use. For the Moonshot program, I developed a list of trials from Clinicaltrials.gov that I felt were important in colorectal cancer. I have looked at clinical trials that people have found and deciphered the criteria for enrollment. With all this experience, I was surprised to learn that some of my beliefs about clinical trials were not true.
I was asked to help a young woman find clinical trials before she would need them. She was 38 and had been diagnosed with 20+ liver metastases and 10+ lung metastases four months after the birth of her first baby. I started with Clinicaltrials.gov and her tumor profile. She had been on FOLFOXIRI and had to stop Oxaliplatin and then eventually irinotecan. The initial list was 65+ trials which I narrowed down over the weeks to ten. I called several sites, and they were extremely helpful and encouraging. While my friend was only on 5-FU, she had progression and was hospitalized several times. NIH (National Institutes of Health) was set to enroll her into a trial until I mentioned that she was on oxygen. The trial coordinator told me that she needs to have Performance Status of 1 but not less than 2. Unfortunately, she did not.
I was intrigued, and I looked up the other trials. They all required between 0 and 2 on the ECOG performance scale. That is when it hit me. To get into clinical trials you must be relatively healthy, clinical trials cannot be a last-ditch effort, and you may not be healthy enough if you wait too long. This was not the case with my friend. She was willing to go into a trial, but she progressed too quickly. We first spoke in June and she passed away in September.
Her death has inspired me to talk about clinical trials in a rational, informed manner. There are many trials out there for the new immunotherapy or immuno-oncology drugs, but they are not without significant risks. There are other trials that are looking at combining existing treatments to find a combination that may work. The decision to go into a clinical trial should be one that is well informed with the possible risks and possible benefits.
There are certain things that you can do when first diagnosed with metastatic colorectal cancer
- Ask for a multidisciplinary team to assess your treatment plan. Include palliative care at the beginning. They will help with the management of pain and side effects. Remember this is not hospice.
- Ask what your options are, the treatment types available, and the pros and cons of each.
- Start looking into clinical trials. Many require that you fail 2 lines of therapy, but it is never too early to generate a list. I know this is easier said than done but time is of the essence. There are also trials that require you to be treatment naïve. Look at these and make your best-informed decision.