Clinical Trials | A022104: Testing the addition of an anti-cancer drug, irinotecan, to the standard chemotherapy treatment (FOLFOX) after long-course radiation therapy for advanced-stage rectal cancers to improve the rate of complete response and long-term rates of organ preservation and continuing response.

The University of Virginia Comprehensive Cancer Center seeks adults ages 18 and over with locally advanced rectal cancer. The purpose of this study is to compare the usual treatment alone (FOLFOX or CAPOX after chemoradiation) to using FOLFIRINOX after chemoradiation. The use of FOLFIRINOX after chemoradiation could lead to a higher response rate and thus a higher rate of clinical complete response (no tumor by exam, sigmoidoscopy, or MRI). This study will help the study doctors find out if this different approach is better than the usual approach. To decide if it is better, the study doctors will be looking to see if the FOLFIRINOX after chemoradiation increases the response rate for the primary rectal tumor and leads to higher rates of clinical complete response (and thus a chance to avoid surgery) compared to the usual approach (FOLFOX or CAPOX after chemoradiation). This chemotherapy regimen, FOLFIRINOX, is already approved by the FDA for use in rectal cancer. But, most of the time it is not used until FOLFOX stops working. This study has 2 study groups. Group 1 will receive the usual drugs used to treat this type of cancer (FOLFOX or CAPOX) after long-course chemoradiation. Group 2 will receive a drug treatment called FOLFIRINOX (Leucovorin, 5-Fluorouracil, Irinotecan, Oxaliplatin) after long-course chemoradiation. You will be assigned to one of the groups through a process called “randomization” which means that your doctor will not choose and you cannot choose which study arm you are in. You will have 50% chance of being in Group 1 or Group 2. The study involves receiving the study drugs, as well as coming in for study visits, which include exams, laboratory tests, and procedures such as having your blood drawn, imaging, and talking to the study doctor. If you decide to take part in this study, you will get long-course chemoradiation (usual treatment) for up to 5 weeks. Then you will either receive the usual treatment with FOLFOX (8 cycles, each cycle is 2 weeks) or CAPOX (5 cycles, each cycle is 3 weeks) or you will receive the study treatment with FOLFIRINOX for 8 cycles (each cycle is 2 weeks). After you finish your treatment, your doctor will continue to follow your condition and watch you for side effects. They will check you about every 3 months for 2 years after treatment. After that, they will check you about every 6 months for 3 years up to 5 years. This means you will keep seeing your doctor for 5 years after treatment. You and/or your insurance plan will need to pay for the costs of medical care you get as part of the study, just as you would if you were getting the usual care for your cancer. Additional information can be found here: https://www.clinicaltrials.gov/study/NCT05610163 [email protected]