[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"ampulla-of-vater-carcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:ampulla-of-vater-carcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,50],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100614772","studying-the-pagoda-algorithm-for-chemotherapy-dose-changes-to-prevent-unplanned-treatment-delays-100614772",false,"NCT07283939","Studying the PAGODA Algorithm for Chemotherapy Dose Changes to Prevent Unplanned Treatment Delays","PAGODA: Randomized Trial of a Proactive Graduated Dose Modification Algorithm for FOLFOX Chemotherapy to Prevent Unplanned Delays","Inclusion Criteria:\n\n* \\* REGISTRATION ELIGIBILITY CRITERIA (STEP 1)\n\n  * Histologic confirmation of invasive cancer that is confirmed or suspected to arise from the gastrointestinal (GI) tract\n  * Any stage for which FOLFOX-based chemotherapy is a clinically-indicated, standard-of-care treatment (adjuvant, neoadjuvant, or first-line chemotherapy)\n  * Eligible primary tumor sites include the esophagus, gastroesophageal junction, stomach, small intestine, ampulla of Vater, appendix, colon, rectum, and cancers of unknown primary with suspected GI origin\n  * Prior systemic therapy for GI cancer (other than cycle 1 of FOLFOX-based chemotherapy) is not allowed. Prior radiation-sensitizing chemotherapy is permitted\n  * The planned duration of FOLFOX-based chemotherapy must be at least four cycles (1 cycle = 14 days)\n  * Cycle 1, day 1 of FOLFOX-based chemotherapy must be completed 1 to 8 days prior to registration\n  * Cycle 1, day 1 of FOLFOX-based chemotherapy must include minimum ordered doses of oxaliplatin (≥ 65 mg\u002Fm\\^2) and infusional 5-FU (2400 mg\u002Fm\\^2\u002F46 hours). Use of the 5-FU bolus is at the discretion of the treating physician\n  * Patients who require primary prophylactic white blood cell growth factor with cycle 1 of FOLFOX chemotherapy due to high risk for fever and neutropenia are not eligible\n  * History of hypersensitivity reaction to oxaliplatin or other platinum-based drugs, to fluorouracil, or to leucovorin, and the excipients in their formulations are not eligible\n  * Age ≥ 18 years\n  * ECOG performance status ≤ 2\n  * Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3\n  * Platelet count ≥ 100,000\u002Fmm\\^3\n  * Total bilirubin ≤ 3 x upper limit of normal (ULN)\n  * AST (SGOT)\u002FALT (SGPT) ≤ 5 x upper limit of normal (ULN)\n  * Calc. creatinine clearance ≥ 30 mL\u002Fmin\n  * Not pregnant and not nursing, because this study involves agents that have known genotoxic, mutagenic and teratogenic effects. Therefore, for women of childbearing potential only, a negative pregnancy test done ≤ 30 days prior to registration is required\n  * Patients with treated brain metastases are eligible if follow-up brain imaging after CNS-directed therapy shows no evidence of progression\n  * Patients with known HIV infection are eligible if receiving effective anti-retroviral therapy with undetectable viral load within 6 months prior to registration\n  * Patients with known chronic hepatitis B virus (HBV) infection are eligible if HBV DNA is undetectable when measured within 6 months prior to registration\n  * Patients with a known history of hepatitis C virus (HCV) infection are eligible if HCV RNA is undetectable when measured at least 12 weeks after completion of antiviral therapy\n  * Patients with known history or current symptoms of cardiac disease are eligible if the New York Heart Association Functional Classification is class I or II\n  * Patients with a known history of congenital long QT syndrome are ineligible\n  * Patients with known DPD deficiency are ineligible\n* \\* NON-PATIENT (ONCOLOGY PHYSICIAN OR ONCOLOGY ADVANCED PRACTICE PROVIDER ELIGIBILITY:\n\n  * The non-patient provider participant is a medical oncologist or oncology advanced practice provider with responsibility for signing and making necessary modifications to chemotherapy orders for a subject assigned to the intervention arm (Arm B). Non-patient participants may not be enrolled more than once over the course of the study\n  * The non-patient participant must be proficient in the English language\n  * The non-patient participant must be age 21 years or older",true,"ALL","18 Years",{"count":20,"type":21},420,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study seeks to learn whether using the PAGODA algorithm to guide chemotherapy dosing will lower the chance of unplanned delays during chemotherapy for cancer in the gastrointestinal system compared to usual care.",[27,28,29,30,31,32,33,34,35,36],"Ampulla of Vater Carcinoma","Appendix Carcinoma","Carcinoma of Unknown Primary With Gastrointestinal Profile","Colon Carcinoma","Esophageal Carcinoma","Gastric Carcinoma","Gastroesophageal Junction Carcinoma","Malignant Digestive System Neoplasm","Rectal Carcinoma","Small Intestinal Carcinoma","RECRUITING","2026-07-01",{"date":40,"type":41},"2026-07-02","ACTUAL",{"date":43,"type":41},"2026-02-13",{"date":45,"type":21},"2030-05-02",{"name":47,"class":48},"Alliance for Clinical Trials in Oncology","OTHER",344,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":62,"conditions":63,"keywords":71,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":84},"100541703","phase-2-dostarlimab-for-locally-advanced-or-metastatic-cancer-non-colorectalnon-endometrial-with-tumor-dmmrmsi-100541703","NCT06333314","Dostarlimab for Locally Advanced or Metastatic Cancer (Non-colorectal\u002FNon-endometrial) With Tumor dMMR\u002FMSI","Dostarlimab as First-line Treatment for Patients With dMMR\u002FMSI (Non-colorectal\u002FNon-endometrial) Locally Advanced or Metastatic Cancer: a Randomized Phase 2 Trial (Cohort Pan-MSI ACSE) With Crossover in the Standard Arm at Progression","Pan-MSI-ACSE","Inclusion Criteria:\n\n1. Patient must have signed a written informed consent form prior any trial specific procedures. -\n2. 18 years or older patients.\n3. Documented locally advanced or metastatic disease with no previous systemic anti-cancer treatment in these settings and not suitable for complete surgical resection.\n4. Histologically proven, dMMR\u002FMSI-H solid tumors that are not colorectal or endometrial cancers and including one of the following: duodenum and small bowel adenocarcinoma, gastric and oeso-gastric junction adenocarcinoma with CPS\\\u003C5, pancreatic adenocarcinoma, ampulla of Vater adenocarcinoma, adrenocortical carcinoma, carcinoma of unknown primary site, neuroendocrine carcinoma (Grade 3) all primary, and soft tissue sarcoma except Gastro-Intestinal Stromal Tumor (GIST).\n5. If patient received adjuvant therapy for non-metastatic disease, this therapy should be completed more than 6 months before the diagnosis of metastatic or recurrent disease.\n6. Availability of minimum 1 block of tumor tissue or 20 slides (archival (\\\u003C2 years) or fresh biopsy specimen of primary and or metastasis) for centralized confirmation of MMR\u002FMSI status by IHC or NGS\u002FPCR, and for Translational Research.\n7. Patients with dMMR\u002FMSI tumor analyzed by IHC, PCR (for Gastric and OGJ adenocarcinoma, and duodenum and small bowel adenocarcinoma only), and\u002For NGS at the recruiting center should be confirmed by central review within 24h (every anonymized patient analysis reporting will be provided for central review). Patients should not be included in the study until the dMMR\u002FMSI status is confirmed by the review committee.\n\n   NB: In case of ambiguous result of IHC (lack of positive internal control, heterogeneous loss of MMR protein expression, ambiguous loss of only one protein including HMSH6 and PMS2), the MSI-H status will be assessed by PCR or NGS for gastric and OGJ adenocarcinoma, and duodenum and small bowel adenocarcinoma, and by NGS for other primary. Based on IHC and PCR or NGS results (NGS will be centrally performed in this case ), the sponsor will decide if inclusion is possible;\n8. Presence of at least one measurable lesion within 28 days before the start of treatment according to RECIST v1.1.\n9. Eastern Cooperative Oncology Group Performance status (ECOG PS) 0-1.\n10. Haematological status: absolute neutrophil count (ANC) ≥1.5 x 10⁹\u002FL; platelets ≥100 x 10⁹\u002FL; haemoglobin ≥9 g\u002FdL.\n11. Adequate renal function: serum creatinine level \\\u003C120 µM, or clearance \\>50 ml\u002Fmin (Modification of the Diet in Renal Disease \\[MDRD\\] or Cockcroft and Gault).\n12. Adequate liver function: serum bilirubin ≤1.5 x upper normal limit (ULN), alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3.0 x ULN, unless liver metastases are present, in which case they must be ≤ 5× ULN.\n13. For patients not taking warfarin: International normalised ratio (INR) \\\u003C1.5 or prothrombin time (PT) \\\u003C1.5 x ULN and either partial thromboplastin time (PTT) or activated PTT (aPTT) \\\u003C1.5 x ULN. Participants taking warfarin may be included on a stable dose with a therapeutic INR \\\u003C3.5.\n14. Women of childbearing potential must have a negative serum pregnancy test performed within 72 hours before the date of randomization.\n15. Men, and women of childbearing potential must agree to use adequate contraception for the duration of trial participation and for 4 months after the last dose of dostarlimab (used in first line or at crossover) or for at least 6 months after the last administration of the chemotherapy agent(s) used in the control arm if no crossover with dostarlimab (according to the current version of the summary of product characteristics (SmPC) of each chemotherapy agent). Men must also agree to not donate sperm and women must agree to not donate oocytes during the specified period.\n16. Registration in a National Health Care System.\n17. Patient is willing and able to comply with scheduled visits, treatment schedule, laboratory tests, tumor biopsies, and other requirements of the study.\n\nExclusion Criteria:\n\n1. Colorectal and endometrial cancer and all primary tumor not listed in inclusion criterion #4.\n2. Previous exposure to anti-PD-1 or PD-L1 or anti-CTL-4 antibodies or treatment with immunotherapy.\n3. Previous exposure to any investigational drug within 4 weeks (6 weeks for monoclonal antibodies) before the first dose in the study.\n4. Previous exposure to any systemic anti-cancer therapy or radiation therapy for the cancer for which the patient is being enrolled.\n5. Active autoimmune disease: Active autoimmune disease requiring systemic treatment in the past 2 years (excluding replacement therapy) or any history of interstitial lung disease (patients with ancient auto-immune disease with stable endocrine oral substitution are eligible).\n6. Uncontrolled central nervous system metastases or carcinomatous meningitis or other concurrent illness or ongoing or active infections.\n7. Patients with HER2-positive gastric carcinoma.\n8. Other serious and uncontrolled non-malignant disease or is considered a poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active infection requiring systemic therapy. Specific examples include, but are not limited to, active, non-infectious pneumonitis; uncontrolled ventricular arrhythmia; recent (within 90 days) myocardial infarction; uncontrolled major seizure disorder; unstable spinal cord compression; superior vena cava syndrome; or any psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.\n9. Prior allogeneic bone marrow transplantation or prior solid organ transplantation.\n10. Has received treatment with systemic corticosteroids or other systemic immunosuppressive medications (including but not limited to prednisone, dexamethasone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) within 2 weeks prior to the first dose of adjuvant treatment or is required to receive systemic immunosuppressive medications during the study. Inhaled or topical steroids and adrenal replacement doses \\>10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.\n\n    Note 1: Patients who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled into the study after approval of the Medical Contact.\n\n    Note 2: patients are permitted the use of topical, ocular, intra-articular, intranasal, and inhalational corticosteroids (with minimal systemic absorption). Adrenal replacement steroid doses including doses \\>10 mg daily prednisone are permitted. A brief (less than 3 weeks) course of corticosteroids for prophylaxis (e.g., contrast dye allergy) or for treatment of non-autoimmune conditions (e.g., delayed-type hypersensitivity reaction caused by a contact allergen) is permitted.\n11. Other concomitant or previous malignancy other than the disease under study, except as noted below:\n\n    i. adequately treated in-situ carcinoma of the uterine cervix, ii. basal or squamous cell carcinoma of the skin, iii. cancer from which the patients was in complete remission for \\>2 years.\n12. Known Human Immunodeficiency Virus (HIV) infection.\n13. Received live vaccine within 14 days.\n14. Patient has documented presence of HBsAg \\[or HBcAb\\] at pre-inclusion visit or within 3 months prior to first dose of study intervention.\n\n    Participant has a positive hepatitis C virus (HCV) antibody test result at pre-inclusion visit or within 3 months prior to first dose of study intervention. Note: Participants with a positive HCV antibody test result due to prior resolved disease can be enrolled, only if a confirmatory negative HCV RNA test is obtained.\n\n    Participant has a positive HCV RNA test result at pre-inclusion visit or within 3 months prior to first dose of study intervention. Note: The HCV RNA test is optional and participants with negative HCV antibody test are not required to undergo HCV RNA testing as well\n15. Known prior severe hypersensitivity to investigational product or any component in its formulation.\n16. Pregnant or breast feeding women.\n17. Participation in another clinical trial within 30 days prior to the first study treatment administration or concomitantly with the trial.\n18. Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.\n19. Person deprived of their liberty or under protective custody or guardianship.\n\nPatient randomized to receive SOC (Arm B) may crossover to receive dostarlimab (Arm A) in case of documented progressive disease according to RECIST v1.1.\n\nInclusion and exclusion are the same for the crossover except for the inclusion criteria #3 and #4.\n\nThe criterion #3 for crossover is: Patient included in the protocol and randomized in the arm \"standard of care\" with documented progressive disease by RECIST v1.1 on standard of care (defined in the protocol).\n\nThe criterion #4 for crossover is: Previous exposure to chemotherapy for locally advanced or metastatic disease.",{"count":59,"type":21},120,[61],"PHASE2","The goal of this open-label randomized, multicenter, comparative phase II trial is to evaluate the efficacy of the immunotherapy, dostarlimab, as first-line treatment for deficient mismatch repair (dMMR)\u002Fmicrosatellite instability (MSI) non-resectable metastatic or locally advanced non-colorectal and non-endometrial cancers compared to the standard of care chemotherapy.\n\nAdult patients (aged ≥18 years) with histologically confirmed dMMR\u002FMSI duodenum and small bowel adenocarcinoma, gastric and oeso-gastric junction (OGJ) adenocarcinoma with combined positive score (CPS)\\\u003C5, pancreatic adenocarcinoma, ampulla of vater adenocarcinoma, adrenocortical carcinoma, carcinoma of unknown primary site, neuroendocrine carcinoma (Grade3) all primary, and soft tissue sarcoma (except Gastro-Intestinal Stromal Tumor) will be included in this study. They will be randomized and treated with either dostarlimab (experimental arm A), or chemotherapy (control arm B).\n\nPatients with documented disease progression following the first line chemotherapy (Arm B) may be eligible for crossover to be treated with dostarlimab, with the same schedule as arm A.",[64,27,65,66,67,68,69,70],"Pancreatic Adenocarcinoma","Adrenocortical Carcinoma","Neuroendocrine Carcinoma","Soft Tissue Sarcoma","Small Bowel Adenocarcinoma","Duodenum Adenocarcinoma","Gastric Adenocarcinoma",[72,73,74],"Immunotherapy","locally advanced or metastatic cancer","dMMR\u002FMSI (non-colorectal\u002Fnon-endometrial) cancer","2025-11-24",{"date":77,"type":41},"2025-12-02",{"date":79,"type":41},"2024-07-23",{"date":81,"type":21},"2030-09",{"name":83,"class":48},"UNICANCER",22]