[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"colon-cancer-stage-iii\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:colon-cancer-stage-iii":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,44,152,178,201],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100453082","phase-2-adjuvant-mfolfirinox-for-high-risk-stage-iii-colon-cancer-100453082",false,"NCT05179889","Adjuvant mFOLFIRINOX for High-risk Stage III Colon Cancer","mFOLFIRINOX Versus mFOLFOX 6 as Adjuvant Treatment for High Risk Stage III (pT4N1\u002F2 or pTanyN2) Colon Cancer: Multicenter, Open Labeled, Randomized, Phase II Study","Inclusion Criteria:\n\n1. Age of 20-70 years with an ECOG ≤ 2\n2. Age of 71-75 years with an ECOG = 0\n3. Pathologically confirmed high-risk stage III colon adenocarcinoma (pT4N1 or pTanyN2)\n4. Curative radical resection (successful R0 resection) within 60 days before randomization\n5. Adequate organ functions\n\n   * ANC ≥ 2×106 cells\u002FmL\n   * Hemoglobin ≥ 9.0 g\u002FdL\n   * Platelets ≥ 100×106 cells\u002FmL\n   * Alanine aminotransferase\u002Faspartate aminotransferase ≤2.5 × times the upper limit of normal (ULN)\n   * Serum total bilirubin ≤ 1.5 ULN\n   * Alkaline phosphatase ≤ 2.5 × ULN\n   * Serum creatinine ≤1.5 × ULN or creatinine clearance \\> 50 mL\u002Fmin (Cockcroft-Gault formula)\n6. Able to understand and willing to sign and date written voluntary informed consent form\n7. Life expectancy ≥ 5 years\n\nExclusion Criteria:\n\n1. Distant metastasis\n2. Middle or lower rectal cancer of need for radiotherapy\n3. Postoperative complication of 3 or more grades of Clavien-Dindo classification\n4. Underlying disease or postoperative condition which is contraindication for chemotherapy\n5. Known hypersensitivity reaction to any study treatment component\n6. Familial adenomatosis polyposis or hereditary non-polyposis colorectal cancer\n7. Inflammatory bowel disease\n8. Previous other malignancy which cannot be curatively treated\n9. Pregnancy or breast feeding\n10. Any other situation would exclude the patient from study based on the investigator's opinion","ALL","20 Years","75 Years",{"count":20,"type":21},308,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","A multicenter, open labeled randomized, phase II trial comparing mFOLFIRINOX and mFOLFOX6 as adjuvant treatment for high risk stage III (pT4N1\u002F2 or pTanyN2) colon cancer",[28],"Colon Cancer Stage III",[30],"High risk stage III (pT4N1\u002F2 or pTanyN2) colon cancer","RECRUITING","2026-03-17",{"date":34,"type":35},"2026-03-19","ACTUAL",{"date":37,"type":35},"2021-07-06",{"date":39,"type":21},"2031-03-15",{"name":41,"class":42},"Chungnam National University Hospital","OTHER",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":22,"phases":55,"briefSummary":57,"conditions":58,"keywords":137,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":43},"100432171","virtual-reality-for-gi-cancer-pain-to-improve-patient-reported-outcomes-100432171","NCT04907643","Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes","Randomized Controlled Trial of Virtual Reality for GI Cancer Pain to Improve Patient Reported Outcomes","Inclusion Criteria:\n\n* Have a primary malignancy of the biliary tract, colon, liver, pancreas, peritoneum, rectum, small intestine, or stomach, with no plan for resection during the study period\n* Tumor types including, but not limited to, adenocarcinoma, squamous cell carcinoma, neuroendocrine tumors, and tumors of mesenchymal origin will be eligible\n* Have clinically significant visceral pain, measured using the standardized NIH PROMIS GI Pain Scale defined as scoring at least 5 points above the nationally normed score\n* Ability to read and write in English\n\nExclusion Criteria:\n\n* Have a condition that interferes with VR usage, including but not limited to seizures, facial injury precluding safe placement of headset, and visual impairments\n* Have cognitive impairment that affects protocol participation. This will be done with a three part cognitive assessment during the initial phone call to assess eligibility followed by consent discussion if eligible.\n* Have brain metastases\n* Have a prognosis of \\\u003C3 months from the time of enrollment per treating oncologist","18 Years","99 Years",{"count":54,"type":21},360,[56],"NA","Patients with digestive tract malignancy often experience severe and unremitting abdominal pain that negatively affects physical, emotional, and social function, as well as health related quality of life (HRQOL). Therapeutic virtual reality (VR) has emerged as a promising and evidence-based treatment modality for cancer pain. Users of VR wear a pair of goggles with a close-proximity screen in front of the eyes that creates a sensation of being transported into lifelike, three-dimensional worlds. To date, VR has been limited to short-term clinical trials for cancer pain. Moreover, limited research exists on theory-based VR modalities beyond mere distraction, such as VR that employs acceptance and commitment therapy (ACT) with components of biofeedback and mindfulness. To bridge these gaps, this study seeks to: (1) assess the impact of immersive VR on patient-reported outcomes (PROs), including pain, activity metrics, and opioid use among patients with visceral pain from a digestive tract malignancy; (2) assess differences in PROs, activity metrics, and opioid use between skills-based VR therapy vs. distraction VR therapy; and (3) determine patient-level predictors of VR treatment response in visceral cancer pain.\n\nTo address these aims, the study will measure PROs and opioid use in 360 patients randomized among 3 groups and follow them for 60 days after enrollment: (1) an enhanced VR group receiving skills-based VR; (2) a distraction-based VR group receiving patient-selected VR videos; and (3) a VR sham control group using a VR headset with 2-D content. The results will inform best practices for the implementation of VR for visceral cancer pain management and guide selection of patient-tailored experiences.",[59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,28,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136],"Cancer Pain","Visceral Pain","Gastrointestinal Neoplasms","Cancer of Gastrointestinal Tract","Small Intestine Cancer","Pancreas Cancer","Liver Cancer","Colon Cancer","Biliary Tract Cancer","Stomach Cancer","Rectum Cancer","Peritoneal Cancer","Gastrointestinal Cancer Metastatic","Gastrointestinal Cancers - Anus","Gastrointestinal Cancers - Stomach","Gastrointestinal Cancers - Colorectal","Gastrointestinal Cancers - Small Intestine","Small Intestine Cancer Stage III","Small Intestine Cancer Stage IV","Small Intestine Cancer, Recurrent","Pancreas Cancer, Stage III","Pancreas Cancer, Stage IV","Pancreas Cancer, Metastatic","Pancreas Cancer, Recurrent","Liver Cancer Stage IIIa","Liver Cancer Stage IIIb","Liver Cancer Stage IIIc","Liver Cancer Stage IV","Colon Cancer Stage IV","Stomach Cancer Stage III","Stomach Cancer Stage IV","Stomach Cancer Recurrent","Rectum Cancer, Recurrent","Gastrointestinal Cancers - Liver","Anal Cancer","Anal Cancer Stage III","Anal Cancer Stage IV","Anal Cancer Recurrent","Anal Cancer Metastatic","Anal Cancer, Stage IIIA","Anal Cancer, Stage IIIB","Appendix Cancer","Ampullary Cancer","Bile Duct Cancer","Bile Duct Cancer Stage III","Bile Duct Cancer Stage IV","Bile Duct Cancer Stage IVA","Bile Duct Cancer Stage IVB","Bile Duct Cancer Recurrent","Carcinoid Tumor","Carcinoid Tumor of Pancreas","Carcinoid Tumor of Large Intestine","Carcinoid Tumor of GI System","Carcinoid Tumor of Colon","Carcinoid Tumor of Liver","Carcinoid Tumor of Cecum","Carcinoid Tumor of Ileum","Carcinoid Tumor of Rectum","Carcinoid Tumor of the Small Bowel","Carcinoid Tumor of the Stomach","Large Intestine Cancer","Esophagus Cancer","Esophagus Cancer, Stage III","Esophagus Cancer, Stage IV","Esophagus Cancer, Recurrent","Gallbladder Cancer","Gallbladder Cancer Stage III","Gallbladder Cancer Stage IV","Gastric (Stomach) Cancer","Neuroendocrine Tumor","Peritoneum Cancer","Rectal Cancer","Esophagus Cancer, Stage I","Esophagus Cancer, Stage II","Gallbladder Cancer Stage I","Gallbladder Cancer Stage II","Bile Duct Cancer Stage I","Bile Duct Cancer Stage II",[138,139,140,141,142],"Virtual Reality","VR","support","GI cancer","cancer pain","2026-02-18",{"date":145,"type":35},"2026-02-20",{"date":147,"type":35},"2021-10-05",{"date":149,"type":21},"2027-03-16",{"name":151,"class":42},"Cedars-Sinai Medical Center",{"id":153,"slug":154,"hasResults":11,"nctId":155,"briefTitle":156,"officialTitle":157,"acronym":158,"eligibilityCriteria":159,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":160,"targetDuration":4,"studyType":22,"phases":162,"briefSummary":163,"conditions":164,"keywords":165,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":169,"lastUpdatePostDateStruct":170,"startDateStruct":172,"completionDateStruct":174,"leadSponsor":176,"locationsCount":43},"100579895","phase-2-phase-ii-study-of-neoadjuvant-dostarlimab-in-patients-with-untreated-t3-4n0-2-or-stage-iii-pmmrmss-resectable-colon-cancer-100579895","NCT06830239","Phase II Study of Neoadjuvant Dostarlimab in Patients With Untreated T3-4N0-2 or Stage III pMMR\u002FMSS Resectable Colon Cancer","Early Phase II Exploratory, Open-Label, Non-Randomized Study of Neoadjuvant Dostarlimab Monotherapy in Participants With Untreated T3-4N0-2 or Stage III pMMR\u002FMSS Resectable Colon Cancer","Superhero","Inclusion Criteria:\n\n* at least 18 years of age and capable of giving informed consent\n* primary adenocarcinoma colon cancer than can be removed surgically, staged cT3-4, cN0-2, cM0 or stage III\n* tumour expresses an MMR proficient\u002Fmicrosatellite stable called MSS\n* tissue samples from tumour and colon mucosa available for molecular analyses\n* capable of receiving immunotherapy\n* adequate general health status and organ function (blood tests)\n\nExclusion Criteria:\n\n* no prior cancer treatment\n* not pregnant and using effective contraception if applicable",{"count":161,"type":21},10,[24],"Dostarlimab belongs to a class of drugs called PD-1 inhibitors that use your own immune system to treat cancer (immunotherapy). It is designed to stop cancer from growing by helping your immune system recognize and fight the cancer. This investigational medicinal product (IMP) has been approved by the Belgian authorities, but not for the treatment of colon cancer.\n\nIt is known that a small number of patients with pMMR\u002FMSS colon cancer may have significant response to medication of this type (immunotherapy) depending on each person's biology.\n\nTrial intervention for all patients will be neo-adjuvant dostarlimab 500 mg IV, given alone by intravenous infusion. Two administrations of dostarlimab are foreseen, at three weeks interval, before surgery for your colon cancer. It has not yet been proven that this treatment can cure, improve or stabilise your disease or condition.\n\nThe study aims to investigate specific molecular changes in tumour and blood after dostarlimab monotherapy administered and before surgery which could be associated with improved response to conventional treatment in some patients. If you decide to participate, as the duration of treatment with dostarlimab is 6 weeks, surgery may be slightly delayed compared to patients that are not treated with dostarlimab and go directly for surgery. It remains uncertain if this is beneficial in your personal situation but some patients might experience significant response. The risks have been carefully assessed and the potential benefits for some patients are considered important and justify undertaking the treatment.\n\nSubsequent therapy after surgery remains at the discretion of the treating physician.\n\nThe duration of a patient on trial will last up to 4 months from the first dose of dostarlimab and afterwards 2 years of follow up is applicable.",[28],[66,166,167,168],"Neoadjuvant","pMMR\u002FMSS","Resectable","2026-02-10",{"date":171,"type":35},"2026-02-12",{"date":173,"type":35},"2025-04-03",{"date":175,"type":21},"2028-12",{"name":177,"class":42},"Universitaire Ziekenhuizen KU Leuven",{"id":179,"slug":180,"hasResults":11,"nctId":181,"briefTitle":182,"officialTitle":183,"acronym":4,"eligibilityCriteria":184,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":22,"phases":187,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":194,"completionDateStruct":196,"leadSponsor":198,"locationsCount":200},"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":186,"type":21},700,[25],"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.",[190,28],"Colon Cancer Stage II","2025-08-22",{"date":193,"type":35},"2025-08-29",{"date":195,"type":35},"2024-10-22",{"date":197,"type":21},"2028-09-01",{"name":199,"class":42},"IFOM ETS - The AIRC Institute of Molecular Oncology",26,{"id":202,"slug":203,"hasResults":11,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":4,"eligibilityCriteria":207,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":18,"enrollmentInfo":208,"targetDuration":4,"studyType":22,"phases":210,"briefSummary":211,"conditions":212,"keywords":213,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":217,"lastUpdatePostDateStruct":218,"startDateStruct":220,"completionDateStruct":222,"leadSponsor":224,"locationsCount":43},"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%",{"count":209,"type":21},840,[25],"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.",[190,28],[214,215,216],"neoadjuvent chemotherapy","FOLFOXIRI","colon caner","2022-01-14",{"date":219,"type":35},"2022-01-18",{"date":221,"type":35},"2021-12-01",{"date":223,"type":21},"2026-12",{"name":225,"class":42},"Sun Yat-sen University"]