[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"small-bowel-cancer\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:small-bowel-cancer":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,47,71,108,150],{"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":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100523866","locally-ablative-therapy-for-oligo-progressive-gastrointestinal-malignancies-livelong-100523866",false,"NCT06101277","Locally ablatIVe thErapy for oLigo-progressive gastrOintestiNal maliGnancies (LIVELONG)","LIVELONG","Inclusion Criteria:\n\n1. Must have one of the following histologically and\u002For biochemically confirmed cancers:\n\n   1. Cohort A: (Cohort removed in protocol version 4.0)\n   2. Cohort B: Small bowel\n   3. Cohort C: Pancreatic and ampullary, colorectal, and appendiceal\n   4. Cohort D: (Cohort removed in protocol version 4.0)\n2. Provision of signed and dated informed consent form.\n3. Stated willingness to comply with all study procedures and availability for the duration of the study.\n4. Age ≥18 years at time of consent.\n5. Currently on systemic therapy and a candidate to continue their current line of systemic therapy with no more than a planned 30-day break to allow for local ablative therapy.\n6. ≥ 1 line of systemic therapy for metastatic disease with ≥ 3 months of clinical benefit on most recent line of systemic therapy prior to the development of new metastatic lesions. \\[Clinical benefit: Treating provider assessment that majority of the tumor burden is stable on current systemic treatment and not requiring an immediate change in systemic treatment\\]\n7. ≤ 5 progressing or new metastatic lesions.\n8. All progressing or new metastatic lesions can be safely treated with locally ablative therapies at discretion of treating radiation oncologist and\u002F interventional radiologist.\n\nExclusion Criteria:\n\n1. Medical comorbidities precluding locally ablative therapies.\n2. History of treatment related toxicities that limit or prohibit application of locally ablative therapies.\n3. Progressing intracranial lesions.","ALL","18 Years",{"count":19,"type":20},300,"ESTIMATED","INTERVENTIONAL",[23],"NA","This is a phase 2 pragmatic study that evaluates the clinical benefit of continuing systemic therapy with the addition of locally ablative therapies for oligo-progressive solid tumors as the primary objective. The primary outcome measure is the time to treatment failure (defined as time to change in systemic failure or permanent discontinuation of therapy) following locally ablative therapy.",[26,27,28,29,30,31,32,33],"Small Bowel Cancer","Colorectal Cancer","Appendiceal Cancer","Biliary Cancer","Gall Bladder Cancer","Intrahepatic Cholangiocarcinoma","Extrahepatic Cholangiocarcinoma","Oligoprogressive","RECRUITING","2026-06-30",{"date":37,"type":38},"2026-07-02","ACTUAL",{"date":40,"type":38},"2023-10-05",{"date":42,"type":20},"2039-09-15",{"name":44,"class":45},"University of California, Davis","OTHER",1,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":46},"100499240","individualized-dose-escalation-of-5-fu-for-gastrointestinal-cancer-100499240","NCT05780684","Individualized Dose Escalation of 5-FU for Gastrointestinal Cancer","Adaptive, Individualized Dose Escalation of Fluorouracil-Based Chemotherapy for Gastrointestinal Cancer: Pilot Study of the FOX Regimen","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Diagnosis of metastatic or locally advanced\u002Finoperable colorectal cancer or non-colorectal gastrointestinal cancer (including cancers of the stomach, esophagus, appendix, small bowel, and ampulla)\n* Clinically appropriate staging imaging of the chest, abdomen, and pelvis performed within 30 days prior to registration\n* ECOG Performance Status: 0-1\n\nExclusion Criteria:\n\n* Any prior receipt of oxaliplatin or fluoropyrimidine chemotherapy (other than radiation-sensitizing fluoropyrimidine chemotherapy)\n* Prior receipt of systemic chemotherapy in the 6 months prior to Day 1 of Cycle 1 of FOX (other than radiation-sensitizing chemotherapy)\n* Known mismatch repair deficiency or microsatellite instability-high disease\n* Known dihydropyrimidine dehydrogenase (DPD) deficiency, as identified by clinically indicated screening\n* Any confirmed second malignancy that is likely to require systemic therapy during the course of the six-month study period, in the opinion of the enrolling investigator\n* Any of the following baseline laboratory abnormalities:\n\n  * Absolute neutrophil count (ANC) \\\u003C 2,500\u002Fmm3\n  * Platelet count \\\u003C 100,000\u002Fmm3\n  * Hemoglobin \\\u003C 9 g\u002FdL\n  * Creatinine \\> 1.5 x ULN\n  * Total bilirubin \\> 1.5 x ULN\n  * AST\u002FALT \\> 5 x ULN\n  * Patients who are unable to provide informed consent\n  * Patients who are pregnant or breastfeeding\n  * Patients who are incarcerated, homeless, or have active substance use disorders",{"count":55,"type":20},36,[23],"This is a single-arm clinical trial to evaluate the feasibility of a chemotherapy regimen using adaptive, individualized dose escalation of 5-FU chemotherapy for patients who have good tolerance of the initial dose. Study participants will also receive oxaliplatin chemotherapy together with 5-FU, at standard doses. The goal of the study is to examine the feasibility and effectiveness of this approach, using individualized dose escalation of 5-FU in patients who do not have serious side effects at lower doses.",[27,59,60,26,61],"Esophagus Cancer","Appendix Cancer","Ampullary Cancer","2026-06-18",{"date":64,"type":38},"2026-06-22",{"date":66,"type":38},"2023-07-14",{"date":68,"type":20},"2027-12",{"name":70,"class":45},"Dartmouth-Hitchcock Medical Center",{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":4,"eligibilityCriteria":76,"healthyVolunteers":11,"sex":16,"minAge":77,"maxAge":4,"enrollmentInfo":4,"targetDuration":4,"studyType":78,"phases":4,"briefSummary":79,"conditions":80,"keywords":4,"overallStatus":100,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":4,"completionDateStruct":4,"leadSponsor":104,"locationsCount":107},"100405976","expanded-access-to-ulixertinib-bvd-523-in-patients-with-advanced-mapk-pathway-altered-malignancies-100405976","NCT04566393","Expanded Access to Ulixertinib (BVD-523) in Patients With Advanced MAPK Pathway-Altered Malignancies","Inclusion Criteria:\n\n* Main Inclusion Criterion:\n\n  1\\. Patient has a MAPK pathway-altered solid tumor(s), including but not limited to KRAS, NRAS, HRAS, BRAF, MEK, and ERK mutations.\n* Other Inclusion Criteria:\n\n  1. In the opinion of the treating physician, the patient has exhausted or has inadequate response to available anti-cancer treatments.\n  2. In the opinion of the treating physician, the patient has adequate organ function to tolerate ulixertinib as defined in section 6.1\n  3. Male or female patients aged ≥ 12 years.\n  4. Patient must be able to swallow and retain orally administered medication.\n\n     Note: Ulixertinib is primarily absorbed in the duodenum and therefore patients with any prior stomach or duodenal resection should be evaluated with that understanding.\n  5. For females, evidence of post-menopausal status or negative urinary or serum pregnancy test for pre-menopausal patients.\n  6. Highly effective contraception for both male and female patients throughout the treatment and for at least 4 months after last treatment administration. In patients under the age of 18, who are not sexually active, abstinence is an acceptable form.\n  7. Toxicities related to any prior treatments are either stable, stable on supportive therapy, resolved, or in the opinion of the treating physician, clinically non-significant\n  8. Ability to understand a written informed consent document, and the willingness to sign it. Assent will be obtained when appropriate based on the patient's age.\n\nExclusion Criteria:\n\n1. Patient is already participating in or qualifies for and is able to enroll in a clinical trial of ulixertinib (BVD-523).\n2. Patient has received systemic therapy with an investigational agent within 5 half-lives or 14 days prior to starting ulixertinib treatment, whichever is shorter.\n3. Patient has received radiotherapy within 14 days prior to the first dose of ulixertinib treatment other than for the allowable treatment of symptomatic bone metastasis.\n4. A history of current evidence\u002Frisk of retinal vein occlusion (RVO) or central serous retinopathy (CSR)\n5. Current evidence of uncontrolled, significant intercurrent illness that would, in the treating physician's judgment, contraindicate the patient's treatment with ulixertinib due to safety concerns.\n6. Patients who, in the opinion of the treating physician, have not fully recovered from recent major surgery to a sufficient extent to tolerate treatment with ulixertinib.\n7. Known hypersensitivity to ulixertinib or any component in its formulation.\n8. Patients taking prohibited medications as described in current Investigator's Brochure.\n\n   Note: Patients who require treatment with Drugs that are strong inhibitors or inducers of CYP1A2, CYP2D6, and CYP3A4 (see Appendix 3) were excluded from the FIH study of ulixertinib and should be discussed with xCures to review if any potential benefits outweigh the potential risks.\n9. Patient is actively breastfeeding.\n10. Prior stomach or duodenal resection that in the opinion of the treating physician would affect the breakdown and absorption of ulixertinib.","12 Years","EXPANDED_ACCESS","The objective of this expanded access program is to provide ulixertinib (BVD-523) for compassionate use in advanced cancer patients with MAPK pathway-altered solid tumor(s), including but not limited to KRAS, NRAS, HRAS, BRAF, MEK, and ERK mutations who have incomplete response to or have exhausted available therapies.\n\nUlixertinib is available for treatment as monotherapy or in combination with other clinically tolerable agent(s), conditionally approved by the drug manufacturer.",[81,26,27,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99],"Pancreatic Cancer","Melanoma","Non Small Cell Lung Cancer","Thyroid Cancer","Bladder Cancer","Head and Neck Cancer","Gastric Cancer","Esophageal Cancer","Cholangiocarcinoma","Ovarian Cancer","Hepatocellular Carcinoma","Glioblastoma","MAPK Gene Mutation","KRAS Activating Mutation","BRAF Gene Mutation","NRAS Gene Mutation","HRAS Gene Mutation","MEK Mutation","ERK Mutation","AVAILABLE","2026-06-02",{"date":103,"type":38},"2026-06-04",{"name":105,"class":106},"xCures","INDUSTRY",26,{"id":109,"slug":4,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":115,"targetDuration":4,"studyType":21,"phases":117,"briefSummary":119,"conditions":120,"keywords":124,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":142,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":46},"100460602","NCT05277766","Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer","Intraperitoneal Aerosolized Nanoliposomal Irinotecan (Nal-IRI) in Peritoneal Carcinomatosis From Gastrointestinal Cancer: a Phase I Study","PIPAC-NAL-IRI","Inclusion Criteria:\n\n* Biopsy proven cancer of the pancreas, gallbladder or biliary tract, stomach, small bowel, colon, rectum, or appendix with extensive or irresectable peritoneal carcinomatosis\n* Estimated life expectancy \\> 6 months; \\> 3 months if primary cancer is pancreatic\n* Age ≥ 18 years\n* Adequate performance status (Karnofsky index \\> 60% and WHO performance status \\\u003C 2)\n* Written informed consent obtained prior any act of the research\n\nExclusion Criteria:\n\n* Concomitant systemic (IV) treatment with irinotecan (either as monotherapy or as part of a combination regimen such as FOLFIRI, CAPIRI, or FOLFOXIRI)\n* Pregnancy or breastfeeding during the clinical study\n* Patients of childbearing age unable or unwilling to provide effective contraception during the study and until the end of relevant exposure (extended by 30 days (female participants) or 120 days (male participants) since the IMP is genotoxic).\n* Known allergy or intolerance to irinotecan\n* Significant amount of ascites detectable (exceeding 3l in volume)\n* Intestinal or urinary tract obstruction\n* Extensive hepatic and\u002For extra-abdominal metastatic disease\n* Impaired renal function (serum creatinine \\> 1.5 mg\u002Fdl or calculated GFR (CKD-EPI) \\\u003C 60 mL\u002Fmin\u002F1.73 m²\n* Impaired liver function (serum total bilirubin \\> 1.5 mg\u002Fdl, except for known Gilbert's disease)\n* Platelet count \\\u003C 100.000\u002Fµl\n* Hemoglobin \\\u003C 9g\u002Fdl\n* Neutrophil granulocytes \\\u003C 1.500\u002Fml\n* Patients known to use:\n\n  * CYP3A4 inducers (rifampin, phenytoin, carbamazepine, rifabutin, rifapentine, phenobarbital, St John's wort)\n  * inhibitors of CYP3A4 (clarithromycin, indinavir, itraconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telaprevir, voriconazole) or UGT1A1 (atazanavir, gemfibrozil, indinavir, regorafenib)",{"count":116,"type":20},45,[118],"PHASE1","The PIPAC NAL-IRI study is designed to examine the maximal tolerated dose of nanoliposomal irinotecan (Nal-IRI, Onivyde) administered with repeated pressurized intraperitoneal aerosol chemotherapy (PIPAC), in a monocentric, phase I trial.",[121,122,27,26,60,87,81,123],"Peritoneal Carcinomatosis","Peritoneal Metastases","Bile Duct Cancer",[125,126,127,128,129,130,131,132,133,134,135,136,137,138,89,139,140],"PIPAC","Nal-IRI","Peritoneal carcinomatosis","dose-finding study","pharmacokinetics","pharmacodynamics","safety and efficacy","Onivyde","Primary gastrointestinal cancer","Colorectal cancer","Small bowel cancer","Appendix cancer","Stomach cancer","Pancreatic cancer","dose-escalation study","Peritoneal metastases","2025-06-26",{"date":143,"type":38},"2025-07-01",{"date":145,"type":38},"2022-11-21",{"date":147,"type":20},"2027-04",{"name":149,"class":45},"University Hospital, Ghent",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":21,"phases":160,"briefSummary":161,"conditions":162,"keywords":171,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":175,"lastUpdatePostDateStruct":176,"startDateStruct":178,"completionDateStruct":180,"leadSponsor":182,"locationsCount":185},"100400786","stereotactic-body-radiotherapy-in-patients-with-rare-oligometastatic-cancers-oligorare-100400786","NCT04498767","Stereotactic Body Radiotherapy in Patients With Rare Oligometastatic Cancers (OligoRARE)","Stereotactic Body Radiotherapy in Addition to Standard of Care Treatment in Patients With Rare Oligometastatic Cancers (OligoRARE): a Randomized, Phase 3, Open-label Trial","OligoRARE","Inclusion Criteria:\n\n* Histologically confirmed malignancy with metastatic disease detected on imaging. Biopsy of metastasis is preferred, but not required.\n* Controlled primary tumour, defined as:\n* at least 3 months since original tumour treated definitively, with no progression at primary site\n* Total number of oligometastases of 1-5 including:\n* Brain metastases amenable to radiosurgery or fractionated stereotactic radiotherapy patient who had neurosurgical resection before trial inclusion are allowed and resected brain metastases count to the total number of oligometastases\n* All sites of disease can be safely treated based on the judgement of an experienced radiation oncologist\n* ECOG score 0-2\n* Life expectancy \\> 6 months\n* Age 18 or older\n* Before patient randomization, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations.\n\nExclusion Criteria:\n\n* Primary cancer of prostate, breast, lung or colorectal\n* Serious medical comorbidities precluding radiotherapy:\n* These include interstitial lung disease in patients requiring thoracic radiation, Crohn's disease in patients where the GI tract will receive radiotherapy, or ulcerative colitis where the bowel will receive radiotherapy and connective tissue disorders such as lupus or scleroderma.\n* For patients with liver metastases, moderate\u002Fsevere liver dysfunction (Child Pugh B or C)\n* Substantial overlap with a previously treated radiation volume. Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints herein. For patients treated previously with radiation, biological effective dose calculations should be used to equate previous doses to the tolerance doses listed in the RTQA Guidelines. All such cases should be discussed with one of the study coordinators\n* Brain metastases only, without extra-cerebral metastases\n* Malignant pleural effusion, malignant ascites, meningeal carcinomatosis and peritoneal carcinomatosis\n* Maximum size of 6 cm for lesions outside the brain, except:\n* Bone metastases over 5 cm may be included, if in the opinion of the local radiation oncologist it can be treated safely (e.g. rib, scapula, pelvis)\n* Clinical or radiologic evidence of symptomatic spinal cord compression. Patients can be eligible if surgical resection has been performed, but the surgical site counts toward the total of up to 3 metastases.\n* Metastatic disease that invades any of the following: GI tract (including oesophagus, stomach, small or large bowel), mesenteric lymph nodes, or disseminated skin metastases and lymphangiosis\n* Pregnant or breast feeding women\n* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before randomization in the trial",{"count":159,"type":20},200,[23],"This is a randomized open-label multicentre Phase III superiority study of the effect of adding SBRT to the standard of care treatment on overall survival in patients with rare oligometastatic cancers.\n\nPatients will be randomized in a 1:1 ratio between current standard of care treatment vs. standard of care treatment + SBRT to all sites of known metastatic disease.\n\nThe primary objective of this trial is to assess if the addition of stereotactic body radiotherapy (SBRT) to standard of care treatment improves overall survival (OS) as compared to standard of care treatment alone in patients with rare oligometastatic cancers.",[163,164,86,165,166,85,167,81,168,87,26,88,82,169,170],"Gynecologic Cancer","Skin Cancer","Sarcoma","Renal Cancer","Upper Urinary Tract Carcinoma","Hepatobiliary Cancer","Colon Cancer","Oligometastasis",[172,173,174],"oligometastatic cancer","Stereotactic body radiotherapy","SBRT","2024-08-23",{"date":177,"type":38},"2024-08-26",{"date":179,"type":38},"2021-06-10",{"date":181,"type":20},"2030-02-01",{"name":183,"class":184},"European Organisation for Research and Treatment of Cancer - EORTC","NETWORK",13]