[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"locally-advanced-unresectable-pancreatic-ductal-adenocarcinoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:locally-advanced-unresectable-pancreatic-ductal-adenocarcinoma":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100589739","phase-3-testing-higher-dose-radiation-therapy-for-locally-advanced-pancreatic-cancer-100589739",false,"NCT06958328","Testing Higher Dose Radiation Therapy for Locally Advanced Pancreatic Cancer","A Phase III Randomized Trial of Dose Escalated Radiation in Locally Advanced Pancreas Cancer (LAPC) Patients (LAP100)","LAP100","Inclusion Criteria:\n\n* At time of enrollment, the patient must have received 4-6 months of active chemotherapy with FOLFIRINOX or NALIRIFOX or gemcitabine\u002Fnab-paclitaxel. Patients are permitted to receive more than 1 type of chemotherapy for toxicity reasons, but not for disease progression. \"Active chemotherapy\" refers to time on chemotherapy not counting treatment breaks (i.e. if a patient had 1 month of chemotherapy followed by 1 month break, this would count as 1 month chemotherapy). Study registration must occur within 45 days of last day of chemotherapy cycle\n* BASELINE PRE-ENTRY CHEMOTHERAPY REQUIREMENTS:\n* Pathologically (histologically or cytologically) proven diagnosis of pancreatic ductal adenocarcinoma\n* Locally advanced unresectable disease (as defined per the National Comprehensive Cancer Network \\[NCCN\\] guidelines and institutional tumor board review)\n* Patients must have baseline pre-chemotherapy scans for staging. Options include: CT chest\u002Fabdomen\u002Fpelvis, CT chest\u002FMRI abdomen\u002Fpelvis, CT chest\u002FCT pelvis\u002FMRI abdomen, or PET\u002FCT performed prior to enrollment\n* Age ≥ 18 years\n* Performance status Eastern Cooperative Oncology Group (ECOG) 0-2\n* Required initial laboratory values:\n\nAll laboratory values must be obtained any time prior to initiation of chemotherapy up to 30 days post initiation of chemotherapy\n\n* Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 x upper limit of normal (ULN)\n* BASELINE CA19-9 AND BILIRUBIN REQUIREMENTS: The purpose is to obtain a baseline CA19-9 in the setting of a normal (or close to normal) bilirubin, since serologic response by serial CA19-9 measurements is part of post-chemotherapy eligibility criteria\n\n  * If baseline CA19-9 \\> 37 U\u002FmL the concurrent bilirubin must be ≤ 1.5 x ULN. (Note: if the bilirubin is not ≤ 1.5 x ULN both the CA19-9 and concurrent bilirubin can be repeated until bilirubin is ≤ 1.5 x ULN, as long as done within specified timeframe \\[up to 30 days post chemotherapy initiation\\])\n  * If baseline CA19-9 U\u002FmL ≤ 37, there are no restrictions on the required concurrent bilirubin level, and this can be the accepted baseline value\n\n    * Prior radiation treatment\n* Has the patient had prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields\n* Prior non-overlapping radiation (e.g., breast, head and neck, extremity) is permitted\n* If uncertain about prior overlap, please contact the study principal investigator, Dr. Nina Sanford\n\n  * POST PRE-ENTRY CHEMOTHERAPY REQUIREMENTS:\n  * If baseline CA19-9 is elevated (defined as \\> 37 u\u002FmL) the post-pre-entry chemotherapy CA19-9 must be less than 37 u\u002FmL or a 50% decline from pre-chemotherapy level with absolute value less than 100u\u002FmL\n  * If baseline CA19-9 is not elevated (defined as ≤ 37 u\u002FmL) the post-pre-entry chemotherapy CA19-9 must remain ≤ 37 u\u002FmL\n  * No active duodenal or gastric ulcers\n  * No direct tumor invasion of the bowel or stomach\n  * Restaging scans showing at least stable disease (no progression). Options for scans include: CT chest\u002Fabdomen\u002Fpelvis, CT chest\u002FMRI abdomen\u002Fpelvis, or CT chest\u002FCT pelvis\u002FMRI abdomen, or PET\u002FCT performed prior to enrollment, with restaging CT showing at least stable disease\n  * Not pregnant and not nursing\n  * No cardiac condition that was the primary reason for hospitalization in the last 6 months\n  * New York Heart Association Functional Classification II or better (NYHA Functional Classification III\u002FIV are not eligible) (Note: Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification.)\n  * HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial","ALL","18 Years",{"count":20,"type":21},356,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","This phase III trial compares the effect of dose-escalated radiation therapy to usual care in patients with locally advanced unresectable pancreatic ductal adenocarcinoma who have received an initial 4-6 months of chemotherapy. Usual care options include additional chemotherapy, observation, or standard lower-dose radiation therapy. These treatments may delay tumor growth but have not been shown to improve survival. Radiation therapy uses high energy X-rays to kill cancer cells and shrink tumors. Dose-escalated radiation therapy involves the precise delivery of higher doses to the tumor, often over a shorter period of time. This trial assesses whether using dose-escalated radiation therapy can prolong survival.",[27,28,29,30],"Locally Advanced Unresectable Pancreatic Ductal Adenocarcinoma","Stage II Pancreatic Cancer AJCC v8","Stage III Pancreatic Cancer AJCC v8","Stage IV Pancreatic Cancer AJCC v8","RECRUITING","2026-06-22",{"date":34,"type":35},"2026-06-25","ACTUAL",{"date":37,"type":35},"2025-08-21",{"date":39,"type":21},"2030-10-21",{"name":41,"class":42},"NRG Oncology","OTHER",322]