[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"colon-cancer-stage-ii\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:colon-cancer-stage-ii":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,42,66,92],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100549505","circulating-tumor-dna-based-adjuvant-chemotherapy-in-stage-ii-colon-cancer-patients-the-medocc-create-trial-100549505",false,"NCT06434896","Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial","CrEATE","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Informed consent for PLCRC with specific consent for:\n\n  * additional blood withdrawals\n  * collection and use of tissue for scientific research\n  * invitation for future (experimental) research within the cohort, including TwiCs studies\n* Inclusion in observational PLCRC -MEDOCC substudy\n* Histological confirmed stage II colon cancer\n* Fit enough to receive treatment with combination chemotherapy (fluoropyrimidine and oxaliplatin) according to the treating physician\n\nExclusion Criteria:\n\n* Indication for adjuvant chemotherapy according to treating physician\n* Another malignancy in previous 5 years, with the exception of treated carcinoma in situ or skin cancer other than melanoma\n* Incomplete primary tumor resection (R1 or R2 resection)\n* Contra-indication for fluoropyrimidines or oxaliplatin\n* Pregnancy","ALL","18 Years",{"count":19,"type":20},1320,"ESTIMATED","INTERVENTIONAL",[23],"NA","Patients in the Prospective Dutch ColoRectal Cancer cohort (PLCRC) with non-metastatic colon cancer that gave consent for additional blood withdrawals are enrolled in the observational PLCRC-MEDOCC substudy. In this study, blood is collected before surgery, after surgery and during follow-up. Within PLCRC-MEDOCC, patients with stage II colon cancer that are not considered to have an indication for adjuvant chemotherapy, can be included in the MEDOCC-CrEATE subcohort under the condition that they gave informed consent in PLCRC for biobanking of tissue and for future studies (Trial within Cohorts design).\n\nPatients included in MEDOCC-CrEATE will be randomized 1:1 to the (A) ctDNA-based treatment group versus (B) the standard of care group. A total of 1320 patients will be randomized. Patients randomized to the ctDNA-based treatment group will have their post-surgery samples analysed directly after informed consent for MEDOCC-CrEATE. All patients with detectable ctDNA will be offered adjuvant chemotherapy (3 months CAPOX). Patients with undetectable ctDNA will receive routine follow-up at the surgical department. The aim of this Trial within Cohorts study is to investigate how many patients with detectable ctDNA after surgery start with adjuvant chemotherapy.",[26,27,28],"Circulating Tumor DNA","Recurrence","Colon Cancer Stage II","RECRUITING","2026-05-07",{"date":32,"type":33},"2026-05-12","ACTUAL",{"date":35,"type":33},"2020-03-05",{"date":37,"type":20},"2026-12",{"name":39,"class":40},"UMC Utrecht","OTHER",29,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":49,"targetDuration":4,"studyType":21,"phases":51,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":65},"100553780","phase-3-the-sagittarius-trial-100553780","NCT06490536","The Sagittarius Trial","A Precision Medicine Trial Leveraging Blood-Based Tumor Genomics to Optimize Treatment in Operable Stage III and High-Risk Stage II Colon Cancer Patients","Inclusion Criteria:\n\n* SAGITTARIUS trial written informed consent.\n* Age ≥ 18 years.\n* Histologically confirmed diagnosis of operable stage III and High-Risk stage II CC located at least 12 cm from the anal verge by endoscopy and above the peritoneal reflection at surgery.\n* Availability of the original FFPE tumor tissue.\n* ECOG performance status 0-1.\n* Normal organ functions (as defined in section 9.3).\n* Women with childbearing potential (WOCBP) should complete a pregnancy test and be willing to use highly effective contraceptive methods.\n\nExclusion Criteria:\n\n* History of another neoplastic disease, unless in remission for ≥ 5 years. Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n* Macroscopic or microscopic evidence of residual tumor (R1 or R2 resections). Patients should never have had any evidence of metastatic disease (including presence of tumor cells in the peritoneal lavage).\n* Current or recent treatment with another investigational drug or participation in another investigational study.\n* Patient unable to comply with the study protocol owing to psychological, social or geographical reasons.\n* Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study.\n* Inadequate contraception (male or female patients) if of childbearing or procreational potential.\n* Clinically relevant cardiovascular disease.\n* Acute or subacute intestinal occlusion or history of inflammatory bowel disease or any other autoimmune disease.\n* Pre-existing neuropathy \\> grade 1. Known grade 3 or 4 allergic reaction to any of the components of the treatment.\n* Has a known history of Human Immunodeficiency Virus (HIV).\n* Has a known history of Hepatitis B (defined as Hepatitis B surface antigen \\[HBsAg\\] reactive) or known active Hepatitis C virus infection.\n* Has a known history of active TB (Bacillus Tuberculosis).\n* Has a medical condition that contraindicate the use of the investigational medicinal product (IMP) according to product indications.\n* Prior neoadjuvant treatment administered before surgery.",{"count":50,"type":20},700,[52],"PHASE3","Background \\& Rationale:\n\nColon cancer is a leading cause of cancer deaths, with a high recurrence rate in stage II high-risk and stage III patients due to undetectable micro-metastases. Liquid biopsy (LB) detects residual cancer DNA post-surgery and monitors treatment response.\n\nPrimary Objective:\n\nShow that therapy based on tumor genetics and LB improves outcomes and quality of life for high-risk stage II and stage III colon cancer patients compared to conventional therapy.\n\nSecondary Objectives:\n\nCompare recurrence times. Evaluate side effects and quality of life. Assess cost differences. Validate LB accuracy.\n\nStudy Design: Patients are randomized into standard or personalized treatment groups based on LB results.\n\nFor positive LB results:\n\nRandomized to standard or customized therapy. Monitor treatment response with LB.\n\nFor negative LB results:\n\nRandomized to standard chemotherapy or follow-ups, starting treatment if a positive result appears.\n\nTreatments:\n\nStandard Chemotherapy:\n\nCAPOX (capecitabine and oxaliplatin) FOLFOX (folinic acid, fluorouracil, and oxaliplatin)\n\nPersonalized Treatments:\n\nCustomized chemotherapy with CAPOX. Immunotherapy with nivolumab and ipilimumab. Targeted therapy with trastuzumab and pertuzumab. FOLFOX with anti-EGFR (epidermal growth factor receptor) therapy (panitumumab).\n\nPopulation: 700 patients with operable stage III and high-risk stage II colon cancer.\n\nInclusion Criteria:\n\nAged 18 or older. Confirmed diagnosis. Tumor tissue sample available.\n\nExclusion Criteria:\n\nHistory of other tumors within five years. Metastatic disease or recent experimental study participation. Major cardiovascular diseases, intestinal obstruction, autoimmune diseases, neuropathy, HIV (Human Immunodeficiency Virus), active TB (Tuberculosis), or hepatitis B\u002FC infection.\n\nMedical conditions contraindicating treatment. Prior neoadjuvant treatment administered before surgery.\n\nEndpoints:\n\nPrimary:\n\nEvaluate disease recurrence after two years.\n\nSecondary:\n\nAssess disease recurrence and overall survival at 3 and 5 years. Measure treatment safety and tolerability. Validate LB accuracy. Monitor quality of life using questionnaires.\n\nThe study will last 5 years and be conducted in 25-30 hospitals across Italy, Spain, and Germany.",[28,55],"Colon Cancer Stage III","2025-08-22",{"date":58,"type":33},"2025-08-29",{"date":60,"type":33},"2024-10-22",{"date":62,"type":20},"2028-09-01",{"name":64,"class":40},"IFOM ETS - The AIRC Institute of Molecular Oncology",26,{"id":67,"slug":68,"hasResults":11,"nctId":69,"briefTitle":70,"officialTitle":71,"acronym":4,"eligibilityCriteria":72,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":73,"enrollmentInfo":74,"targetDuration":4,"studyType":21,"phases":76,"briefSummary":77,"conditions":78,"keywords":79,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":89,"locationsCount":91},"100454233","phase-3-neoadjuvant-folfoxiri-versus-immediate-surgery-for-stage-ii-and-iii-colon-cancers-100454233","NCT05194878","Neoadjuvant FOLFOXIRI Versus Immediate Surgery for Stage II and III Colon Cancers","Phase III Study of Neoadjuvant FOLFOXIRI Chemotherapy Versus Immediate Surgery for High-risk Resectable Stage II and III Colon Cancers","Inclusion Criteria:\n\n* Histologically proven adenocarcinoma or high grade dysplasia on histology plus unequivocal radiological evidence of invasive cancer of the colon(≥ 12 cm from the anal verge).\n* pMMR in immunohistochemical detection or MSI-H in MSI test.\n* Determined preoperatively by either spiral or multidetector CT: high risk T3 (tumor disruption of muscle wall and extension into pericolic fat with more than 5 mm protrusion into adjacent mesenteric fat) or T4 (tumor penetrates to the surface of the visceral peritoneum or directly invades or is adherent to adjacent organs or structures).\n* Patients presenting with acute colonic obstruction may enter the trial only after obstruction is relieved by a successful defunctioning stoma, and when recovered to a fitness level consistent with the other eligibility criteria\n* Adequate full blood count: WBC \\>3.0 x109\u002Fl; Plts \\>100 x109\u002Fl. Anaemia (Hb \\\u003C 10.0 g\u002Fdl) is not an exclusion, but should be corrected by transfusion prior to surgery and chemotherapy. If Hb remains low despite transfusions, surgery and chemotherapy can be given at the decision of the surgical and oncology teams.\n* Adequate renal biochemistry: serum creatinine was less than 1.5 times the normal value.\n* Adequate hepatobiliary function: serum total bilirubin and ALT were less than 1.5 times the normal value.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n\nExclusion Criteria:\n\n* Any patient for whom radiotherapy is advised by the MDT\n* Strong evidence of distant metastases or peritoneal nodules (M1)\n* dMMR in immunohistochemical detection or MSI-L\u002FMS-S in MSI test.\n* Peritonitis (secondary to perforated tumour)\n* Colonic obstruction that has not been defunctioned\n* Serious medical comorbidity, eg uncontrolled inflammatory bowel disease, uncontrolled angina or recent (\\\u003C6 months) MI\n* Another serious medical condition judged to compromise ability to tolerate neoadjuvant therapy and\u002For surgery\n* Any other malignant disease within the preceding 5 years with the exception of non-melanomatous skin cancer, carcinoma in situ and early stage disease with a recurrence risk \\\u003C5%","75 Years",{"count":75,"type":20},840,[52],"BACKGROUND:\n\nIn patients with high risk stage II and stage III colon cancer (CC), curative surgery followed by adjuvant chemotherapy with FOLFOX or CAPOX regimens has become a standard treatment. However, 20 to 30 % of these patients will develop distant metastasis, which ultimately result in death. Perioperative chemotherapy is a promising strategy with potential benefits that could be more effective at eradicating micrometastases. Moreover, shrinking tumor before surgery not only facilitate removal of all the tumor by the surgeon but also reduce tumor cell spreading during the procedure. With recent advances in radiology, preoperative computed tomography allows a good prediction of tumor stage (wall penetration and nodal involvement) prior to surgery. The investigators conducted the present randomized study to explore whether perioperative chemotherapy with FOLFOXIRI regimen compared with postoperative chemotherapy could improve disease-free survival in patients with radiologically staged, High-risk, but resectable Stage II or III colon cancer.\n\nOBJECTIVE:\n\nThe primary objective of this study is to evaluate the efficacy of perioperative chemotherapy with FOLFOXIRI regimen compared to postoperative chemotherapy in patients with High-risk Resectable Stage II and III colon cancer. Secondary objectives are efficacy in terms of R0 resection rate, overall survival (OS), relapse-free survival (RFS), down-staging of primary tumors, and tolerability of perioperative therapy and postoperative complications.",[28,55],[80,81,82],"neoadjuvent chemotherapy","FOLFOXIRI","colon caner","2022-01-14",{"date":85,"type":33},"2022-01-18",{"date":87,"type":33},"2021-12-01",{"date":37,"type":20},{"name":90,"class":40},"Sun Yat-sen University",1,{"id":93,"slug":94,"hasResults":11,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":98,"eligibilityCriteria":99,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":100,"targetDuration":4,"studyType":21,"phases":102,"briefSummary":103,"conditions":104,"keywords":105,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":91},"100369384","phase-3-circulating-tumour-dna-based-decision-for-adjuvant-treatment-in-colon-cancer-stage-ii-evaluation-100369384","NCT04089631","Circulating Tumour DNA Based Decision for Adjuvant Treatment in Colon Cancer Stage II Evaluation","Circulating Tumour DNA Based Decision for Adjuvant Treatment in Colon Cancer Stage II Evaluation (CIRCULATE) AIO-KRK-0217","CIRCULATE","Inclusion criteria for screening phase:\n\n1. Resected colon cancer stage II, OR Resected rectal cancer stage II, if there was no indication for radiotherapy (i.e. due to the localisation in the upper third of the rectum ), so that the treatment follows the recommendations for colon cancer. Patients, in whom the tumour stage is not yet know, can be enrolled into the screening.\n2. Signed informed consent for the screening Phase\n\nInclusion criteria for the randomised phase:\n\n1. Resected colon cancer stage II, OR resected rectal cancer stage II, if there was no indication for radiotherapy (i.e. due to the localisation in the upper third of the rectum), so that the treatment follows the recommendations for colon cancer.\n2. Known microsatellite or mismatch repair status\n3. Confirmation, that the ctDNA result is available\n4. Signed second informed consent (for the randomised phase)\n\nExclusion criteria for Screening:\n\n1. Patients with known microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR)\n2. Known clinical high risk situation if it is regarded as certain indication for an adjuvant chemotherapy\n3. Patients, who have an obvious contra-indication for adjuvant chemotherapy (i.e. due to the performance status, comorbidity, active second cancer or age). It should be considered that patients with an age of more than 75 years frequently not fulfil criteria for adjuvant chemotherapy.\n4. R1- or R2-status (patients with \\[still\\] unknown R-status can be screened)\n5. Patients, in whom the randomisation or chemotherapy is unfeasible due to logistic reasons (travel distance, compliance)\n6. Age \\\u003C 18 years\n7. Pregnant or breast feeding patients\n\nExclusion criteria for randomised phase:\n\n1. Patients with microsatellite instability (MSI-H) or mismatch repair deficiency (dMMR)\n2. Known clinical high risk situation if it is regarded as certain indication for an adjuvant chemotherapy\n3. R1- or R2- status, or unknown R- status (Rx)\n4. Number of investigated lymph nodes \\\u003C 10\n5. WHO performance status ≥ 2\n6. Colon or rectal cancer with UICC stage III or IV\n7. Second cancer, except\n\n   1. simultaneous or metachronous colon or rectal cancer with UICC stage ≤ I,\n   2. curatively treated basal cell carcinoma or squamous cell carcinoma of the skin and in-situ cervical carcinoma\n   3. tumours with a disease free survival of more than five years\n8. Contra indications for chemotherapy, especially:\n\n   1. Leukocytes \\\u003C 3,0 Gpt\u002Fl\n   2. Neutrophil granulocytes \\\u003C 1,5 Gpt\u002Fl\n   3. Thrombocytes \\\u003C 100 Gpt\u002Fl\n   4. alanine aminotransferase (ALAT) or (aspartate aminotransferase) ASAT \\> 3x ULN\n   5. Creatinine clearance (calculated according Cockcroft-Gault) \\\u003C 30 ml\u002Fmin\n9. Comorbidities relevantly interfering with the prognosis of the patients, i.e.:\n\n   1. heart insufficiency NYHA III\u002FIV\n   2. relevant coronary heart disease,\n   3. Diabetes mellitus with late sequelae\n10. Organ, stem cell or bone marrow transplantation\n11. Known hypersensitivity to capecitabine In case of known hypersensitivity to oxaliplatin, the patients can participate, but not receive oxaliplatin\n12. Medication with brivudine, sorivudine or analogues in the last four weeks before planned treatment start\n13. Known dihydropyrimidine dehydrogenase (DPD)-deficiency\n14. Acute infections\n15. Known HIV- infections, known active hepatitis B or C-infection\n16. Participation at another interventional study for medical treatment during the last four weeks before randomisation\n17. Neoadjuvant therapy before resection\n18. Patients, in whom the randomisation or chemotherapy is unfeasible due to logistic reasons (travel distance, compliance)\n19. Age \\\u003C 18 years\n20. Pregnant or breast feeding patients\n21. Women of childbearing potential and men with partner with childbearing potential who are not willing to take appropriate precautions to avoid pregnancy with a highly effective method in case they are randomised to \"chemotherapy\"",{"count":101,"type":20},4812,[52],"The CIRCULATE study evaluates the adjuvant therapy in patients with colon cancer UICC stage II. The primary aim of the study is to compare the disease free survival in patients who are positive for postoperative circulating tumour DNA with vs. without capecitabine.",[28],[106,107,108],"circulating tumour DNA","ctDNA","adjuvant chemotherapy","2020-08-05",{"date":111,"type":33},"2020-08-06",{"date":113,"type":33},"2020-06-26",{"date":115,"type":20},"2026-06",{"name":117,"class":40},"Technische Universität Dresden"]