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
The aims of this study are to evaluate if an intensified adjuvant treatment with FOLFOXIRI could increase the rate of cases with undetectable ct-DNA after chemotherapy and to evaluate if a further adjuvant treatment with Trifluridine/Tipiracil could increase the rate of cases with undetectable ct-DNA and therefore improve DFS in a population at high-risk of relapse. An additional target-driven cohort of HER2+ RAS wild-type colon cancer patients will be assessed for ct-DNA clearance after a tailored treatment with Trastuzumab and Tucatinib plus FOLFOX
According to general medical guidelines, adjuvant chemotherapy is used after curative resection of high-risk stage II or III primary colon cancer. However, there exist limitations using clinical trial data acquired from highly selected subjects in a controlled environment. For example, patients aged over 70 years old were in many cases excluded from clinical trials resulting in insufficient data on the efficacy of therapies including oxaliplatin in aged patients, and the source data of the medical guidelines did not fully reflect the conditions of Korean patients. In addition, suggestions are continuously being submitted for existing therapies with modified administration periods and methods with the aim to search for the optimum effect over side effects. Discussions are also held on meta analyses results that imply the need to apply slightly different approaches through small groups of patient and disease factors. As there are more diverse adjuvant therapy protocols that can be applied to post-surgery colon cancer patients, it is necessary to figure out the patterns of adjuvant chemotherapies actually used in Korean medical practices. Also, in order to complement the limitation of external validity of the existing base clinical data, a multifaceted exploratory analysis will be conducted by making follow-up observations on patterns, prognosis results, quality of life, adverse effects, etc. of post-surgery adjuvant chemotherapies actually used in around 30 sites in Korea under the noninterventional observational study conditions.
- 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.
This phase Ib trial studies side effects and best dose of dasatinib in preventing oxaliplatin-induced peripheral neuropathy in patients with gastrointestinal cancers who are receiving FOLFOX regimen with or without bevacizumab. Drugs used in chemotherapy, such as leucovorin, fluorouracil, and oxaliplatin (FOLFOX regimen), work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. However, the buildup of oxaliplatin in the cranial nerves can result in damage or the nerves. Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Blocking these enzymes may reduce oxaliplatin-induced peripheral neuropathy.
Background: 1. . The incidence and mortality of colon cancer are high in China and in the world. 2. . The treatment of many patients in the real world is not standardized, and there are problems such as over-treatment or under-treatment. To explore the adjuvant treatment of colon cancer in the Chinese population, this study will retrospectively analyze real-world data on adjuvant therapy for colon cancer in Chinese patients after radical surgery. The purpose of research: 1. . Current status of adjuvant therapy for stage II-III colon cancer in the real world: chemotherapy regimen, chemotherapy time, efficacy, safety, etc. 2. . Comparison of efficacy and safety of different adjuvant chemotherapy time (<3 months vs. >=3 months) in high-risk stage II and III colon cancer patients in the real world 3. . Comparison of efficacy and safety of different adjuvant chemotherapy regimens (XELOX vs. FOLFOX) in high-risk stage II and III colon cancer patients in the real world
Investigators would like to assess the efficacy and safety of tegafur-uracil in patients with stage II MSI-L or MSS colon cancer under metronomic setting for one year.
OncoVAX® is the first cancer vaccine that both prevents cancer recurrence and addresses the diversity of cancer cells. In this pivotal randomized, multicenter Phase IIIb study in patients with Stage II colon cancer, OncoVAX is designed to use a patient's own cancer cells to mobilize the body's immune system to prevent the return of colon cancer following surgery.
Despite the success of surgery and chemotherapy among people with colon cancer, 30-50% of patients develop recurrent disease. Physical activity has emerged as a potential lifestyle intervention to reduce cancer recurrence and improve survival among people with colon cancer (CC). This pilot study aims to identify the dose-response effects of aerobic exercise on molecular and cellular pathways associated with physical activity and CC outcomes among patients with stage II and III CC.
This pilot clinical trial studies the feasibility of a low glycemic load diet in patients with stage I-III colon cancer. A low glycemic load diet includes foods that have low scores on the glycemic index. The glycemic index is a scale that measures how much a certain carbohydrate causes a person's blood sugar to rise. A low glycemic load diet may help decrease the chance of cancer coming back and improve the survival in patients with colon cancer.