[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100369384":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":32,"locations":37,"responsibleParty":57,"collaborators":18,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":18,"enrollmentInfo":69,"targetDuration":18,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":78,"overallStatus":40,"whyStopped":18,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"Technische Universität Dresden","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Chemotherapy","EXPERIMENTAL","Capecitabine mono or Capecitabine\u002FOxaliplatin as investigator choice:\n\nPatients who are positive for postoperative ctDNA (ctDNApos) and not microsatellite instable are randomized (2:1) to adjuvant chemotherapy with capecitabine or to follow up.\n\nCapecitabine 2 x 1250 mg\u002Fm\\^2, oral (d1-14), repeated at day 22 (- 2 ... + 6 days). Patients with a GFR between 30 and 50 ml\u002Fmin start with capecitabine dose of 2 x 1000 mg\u002Fm\\^2. Treatment duration: 8 cycles (approx. 6 months)\n\nCapecitabine, if combined with Oxaliplatin (investigator choice):\n\nIf the investigation decides to add oxaliplatin, the following schedule should be used:\n\n\\[Oxaliplatin 130 mg\u002Fm\\^2 i.v. (2 hours on d1)\\] Capecitabine 2 x 1000 mg\u002Fm\\^2, oral (d1-14), repeated at day 22 (- 2 ... + 6 days) Treatment duration: 4 or 8 cycles (approx. 3 or 6 months)",[13],"Drug: Capecitabine",{"label":15,"type":16,"description":17,"interventionNames":18},"Follow-up","NO_INTERVENTION","Patients negative for postoperative ctDNA (ctDNAneg) are randomized (1:4) to follow-up within CIRCULATE or to routine follow up outside the Trial protocol.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Capecitabine","6 months capecitabine, in combination with oxaliplatin 3 to 6 months capecitabine",[9],[26],"Xeloda",[28],{"name":29,"affiliation":30,"role":31},"Gunnar Folprecht, Prof.","University hospital \"Carl Gustav Carus\" Dresden","PRINCIPAL_INVESTIGATOR",[33],{"name":29,"role":34,"phone":35,"phoneExt":18,"email":36},"CONTACT","+49 351 458 4794","Gunnar.Folprecht@uniklinikum-dresden.de",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Universitaetsklinikum Carl Gustav Carus, Medizinische Klinik","RECRUITING","Dresden","Saxony","01307","Germany","DE",{"type":47,"coordinates":48},"Point",[49,50],13.73832,51.05089,{"lat":50,"lon":49},[53,56],{"name":54,"role":34,"phone":35,"phoneExt":18,"email":55},"Gunnar Folprecht, Dr.","gunnar.folprecht@uniklinikum-dresden.de",{"name":54,"role":31,"phone":18,"phoneExt":18,"email":18},{"type":58,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR","100369384","phase-3-circulating-tumour-dna-based-decision-for-adjuvant-treatment-in-colon-cancer-stage-ii-evaluation-100369384",false,"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\"","ALL","18 Years",{"count":70,"type":71},4812,"ESTIMATED","INTERVENTIONAL",[74],"PHASE3","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.",[77],"Colon Cancer Stage II",[79,80,81],"circulating tumour DNA","ctDNA","adjuvant chemotherapy","2020-08-05",{"date":84,"type":85},"2020-08-06","ACTUAL",{"date":87,"type":85},"2020-06-26",{"date":89,"type":71},"2026-06",{"name":5,"class":6},1]