NRG-GI004/SWOG-S1610 is a clinical trial that is studying two treatment options for patients with colorectal cancer that has spread to other parts of their body (metastatic). This study is specifically for patients who have a particular type of metastatic colorectal cancer called “MSI-high” or “DNA repair deficient” (these two terms are sometimes used to describe the same thing). This can be learned by doing a specific test on a small piece of the cancer that was used to diagnose the colorectal cancer. For patients with this type of colorectal cancer, doctors know that new medicines may help the patient’s own immune system attack the cancer and this treatment has become a standard. However, these immune system treatments do not work for every “MSI-high” or “DNA repair deficient” metastatic colorectal cancer patient and traditional chemotherapy remains needed for many. This study is trying to answer the question of whether adding traditional chemotherapy and biologic treatment to immunotherapy improves the efficacy compared to immunotherapy alone. Therefore, patients in this study will be randomly assigned to receive one of two treatment options: immunotherapy (using the drug atezolizumab) alone or the same immunotherapy in combination with the chemotherapy and biologic treatment - frequently used for this type of cancer at later lines of therapy - when immunotherapy doesn’t work.
If you agree to take part in this study, you will also have the opportunity to participate in optional sample collections for use of your blood and tumor samples in possible future research studies. An additional sample of tumor tissue from your previous biopsy or surgery and blood samples will be collected if you choose to participate in the sample collection. Researchers use these samples to help them learn more about your cancer, using blood and tissue to find new ways to prevent, detect, treat, or cure cancer.
Below, you can find FAQs about clinical research and this particular clinical trial.
Doctors and researchers conduct a clinical study, also called a “clinical trial,” to find better ways to prevent, diagnose, or treat an illness. NRG Oncology is supported by the National Cancer Institute (NCI) and runs clinical studies specifically for patients with cancer or to prevent cancer. Most clinical studies test something we know against something we don’t know. In all situations, these studies are strictly evaluated before they are allowed to be offered to any patient. The study is designed to answer the question that we do not know the answer to, so that current and future patients may have better treatments or information than what we currently have. There are different types of clinical studies that might be available for patients. For more information see “Types of Clinical Trials” and “Phases of Clinical Trials”.
Patients who volunteer to take part in a clinical study are followed closely by their health care professionals and members of the research team. For more information see “Research Team Members”.
At NRG Oncology, we focus on conducting clinical studies aimed to improve current cancer care practices and the lives of cancer patients. NRG Oncology partners with more than 1,300 member sites world-wide to research ways to improve treatment standards in the cancer community. Our organization is supported primarily through grants from the National Cancer Institute (NCI) and is one of five research groups in the NCI's National Clinical Trial's Network.