View clinical trials related to Stage II Colon Cancer.
Filter by:This is an open-label Phase II trial that will investigate the use of neoadjuvant CAPEOX chemotherapy with Atezolizumab followed by surgery and adjuvant chemotherapy for patients with localized resectable pMMR adenocarcinoma of the colon with a target accrual of 30 patients. The investigators will explore if appropriately timed neoadjuvant CAPEOX with anti-PD-L1 mAb (Atezolizumab) can be administered safely and feasibly for 12 weeks, and that this combination will lead to improved clinical response associated with enhanced numbers of immune cells in surgically resected colon tumors. Participants will receive 4 cycles of atezolizumab in combination with 4 cycles of CAPEOX (atezolizumab will be administered prior to chemotherapy) before standard of care surgical resection. Each cycle of neoadjuvant therapy is 3 weeks. Following surgery, participants still considered to be at high-risk of recurrence (per NCCN guidelines) will receive further adjuvant chemotherapy (mFOLFOX6 or CAPEOX),for 6 and 4 cycles respectively (for a total of 12 weeks), based on the discretion of the treating oncologist/investigator. Participants will be followed up for an EFFICACY follow-up phase every 2 months during the first 6 months after surgery (months 1, 3, 6) and thereafter participants will enter a SURVIVAL follow-up phase and will be seen every 6 months starting at month 12 until month 36. During this the efficacy and survival follow up visits blood samples will be obtained for purposes of obtaining circulating DNA and stool and optional blood samples for storage for future exploratory analysis. Additionally, during these follow up visits, participants will be asked to complete quality of life questionnaires
- Benefit of adjuvant chemotherapy after curative surgery for stage II Colon Cancer is still debated. Several high-risk features may help to stratify stage II cancer patients into groups that will truly benefit from adjuvant chemotherapy. However, those factors are rather subjective, and no specific trial has been designed to answer the high-risk stage II colon cancer question directly. - Immunoscore® Colon, an in vitro diagnostic test, which quantifies the density of CD3+ and CD8+ T lymphocyte populations in the center the tumor (CT) and its invasive margin (IM) using immunohistochemistry and automated image analysis. Immunoscore® has been extensively validated as a prognostic biomarker in early stage CC patients. This unique diagnostic assay measuring host immune response at the tumor site may inform the decision to administer adjuvant chemotherapy in resected Stage II and III CC patients. - This randomized trial is studying how observation compares to adjuvant chemotherapy (investigator's choice) in stage II colon cancer patients with high-risk features and High-Immunoscore®. The trial would represent a unique opportunity to classify stage II CC patients based on their tumor microenvironment with the aim to provide efficient patient stratification to improve clinical care.