[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658916":3},{"organization":4,"outcomesModule":7,"designInfo":59,"detailedDescription":66,"studyPopulation":58,"armGroups":67,"interventions":79,"overallOfficials":89,"centralContacts":94,"locations":58,"responsibleParty":103,"collaborators":58,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":113,"eligibilityCriteria":114,"healthyVolunteers":109,"sex":115,"minAge":116,"maxAge":117,"enrollmentInfo":118,"targetDuration":58,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":133,"overallStatus":149,"whyStopped":58,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":58},{"fullName":5,"class":6},"Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":58},[9,13],{"measure":10,"description":11,"timeFrame":12},"Paricalcitol Efficacy","Proportion of patients achieving a clinicopathologic response (CPR)","12 weeks from treatment initiation",{"measure":14,"description":11,"timeFrame":12},"Pirfenidone Efficacy",[16,20,23,26,28,32,34,37,39,42,44,46,47,50,52,54,55,57],{"measure":17,"description":18,"timeFrame":19},"Severity of Treatment-Emergent Adverse Events for Paricalcitol [Safety]","Maximum severity grade of treatment-emergent adverse events per participant, assessed on a scale from Grade 1 (mild) to Grade 5 (death) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Higher grades indicate a more severe outcome.","16 weeks from treatment initiation",{"measure":21,"description":22,"timeFrame":19},"Severity of Treatment-Emergent Adverse Events for Pirfenidone [Safety]","Maximum severity grade of treatment-emergent adverse events per participant, assessed on a scale from Grade 1 (mild) to Grade 5 (death) according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. Higher grades indicate a more severe outcome",{"measure":24,"description":25,"timeFrame":19},"Incidence of Treatment-Emergent Adverse Events for Paricalcitol [Safety","Number of participants experiencing one or more treatment-emergent adverse events, as graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.",{"measure":27,"description":25,"timeFrame":19},"Incidence of Treatment-Emergent Adverse Events for Pirfenidone [Safety]",{"measure":29,"description":30,"timeFrame":31},"Patient-Reported Quality of Life Outcomes Using the Medical Outcomes Study 20-Item Short-Form Health Survey (SF-20) for Paricalcitol [Tolerability]","Assessment of patient-reported quality of life outcomes using the SF-20 questionnaire. Each subscale ranges from a minimum score of 0 to a maximum score of 100, where higher scores indicate a better health-related quality of life outcome.","12 weeks",{"measure":33,"description":30,"timeFrame":31},"Patient-Reported Quality of Life Outcomes Using the Medical Outcomes Study 20-Item Short-Form Health Survey (SF-20) for Pirfenidone [Tolerability]",{"measure":35,"description":36,"timeFrame":31},"Treatment Adherence Evaluated via Study Drug Diaries for Paricalcitol [Feasibility]","Percentage of total prescribed doses taken based on study drug diaries (number of doses taken divided by total expected doses over 12 weeks).",{"measure":38,"description":36,"timeFrame":31},"Treatment Adherence Evaluated via Study Drug Diaries for Pirfenidone [Feasibility]",{"measure":40,"description":41,"timeFrame":31},"Molecular Biomarker Analysis of Treatment Response in Research Blood Samples for Paricalcitol [Efficacy]","Evaluation of molecular correlates of treatment response using research blood samples collected at baseline and post-treatment.",{"measure":43,"description":41,"timeFrame":31},"Molecular Biomarker Analysis of Treatment Response in Research Blood Samples for Pirfenidone [Efficacy]",{"measure":40,"description":45,"timeFrame":31},"Evaluation of circulating biomarkers of treatment response using research blood samples collected at baseline and post-treatment.",{"measure":43,"description":45,"timeFrame":31},{"measure":48,"description":49,"timeFrame":31},"Biomarker Analysis of Treatment Response in Tissue Biopsy Samples for Pirfenidone [Efficacy]","Quantitative assessment of treatment response using baseline and post-treatment archival tissue biopsy samples, measuring changes in Ki-67 positive tumor cells",{"measure":51,"description":49,"timeFrame":31},"Biomarker Analysis of Treatment Response in Tissue Biopsy Samples for Paricalcitol [Efficacy]",{"measure":51,"description":53,"timeFrame":12},"Quantitative assessment of treatment response using baseline and post-treatment archival tissue biopsy samples, measuring changes in density of Fibroblast Activation Protein-positive (FAP+)",{"measure":48,"description":53,"timeFrame":12},{"measure":51,"description":56,"timeFrame":12},"Quantitative assessment of treatment response using baseline and post-treatment archival tissue biopsy samples measuring changes in collagen density (quantified via Sirius Red or Masson's Trichrome staining).",{"measure":48,"description":56,"timeFrame":12},null,{"allocation":60,"interventionModel":61,"interventionModelDescription":62,"primaryPurpose":63,"observationalModel":58,"timePerspective":58,"maskingInfo":64},"RANDOMIZED","PARALLEL","The trial is randomized 1:1 into two parallel intervention arms","TREATMENT",{"masking":65,"maskingDescription":58,"whoMasked":58},"NONE","This is a single-center, randomized Phase II clinical trial designed to investigate the efficacy of repurposing fibrosis-modulating agents to improve surgical resectability in patients with peritoneal carcinomatosis. Peritoneal carcinomatosis is characterized by a challenging tumor microenvironment (TME) featuring extensive fibrosis and a high density of cancer-associated fibroblasts (CAFs). These elements create a dense desmoplastic barrier that impedes drug penetration, limits therapeutic efficacy, and frequently renders patients ineligible for definitive surgical cytoreduction.\n\nTo overcome these barriers, the trial evaluates two distinct anti-fibrotic agents: paricalcitol, a synthetic Vitamin D receptor agonist that promotes CAF quiescence and stromal remodeling, and pirfenidone, an oral anti-fibrotic agent that inhibits fibrosis by downregulating the TGF-β signaling pathway and collagen synthesis. Eligible participants are randomized in a 1:1 ratio to receive a 12-week course of either oral paricalcitol (2 mcg daily, titratable) or oral pirfenidone (titrated to 801 mg three times daily with food), administered concurrently with their ongoing standard systemic chemotherapy.",[68,74],{"label":69,"type":70,"description":71,"interventionNames":72},"Paricalcitol Arm","EXPERIMENTAL","Participants receive oral paricalcitol once daily for 12 weeks concurrently with standard systemic chemotherapy.",[73],"Drug: Paricalcitol",{"label":75,"type":70,"description":76,"interventionNames":77},"Pirfenidone Arm","Participants receive oral pirfenidone three times daily for 12 weeks (with initial dose titration) concurrently with standard systemic chemotherapy.",[78],"Drug: pirfenidone",[80,85],{"type":81,"name":82,"description":83,"armGroupLabels":84,"otherNames":58},"DRUG","Paricalcitol","Oral, 2 mcg once daily for 12 weeks",[69],{"type":81,"name":86,"description":87,"armGroupLabels":88,"otherNames":58},"pirfenidone","Oral, titrated up to 801 mg three times daily (total daily dose: 2403 mg\u002Fday) with food for 12 weeks.",[75],[90],{"name":91,"affiliation":92,"role":93},"Patrick Wagner","AHN Health Network","PRINCIPAL_INVESTIGATOR",[95,100],{"name":96,"role":97,"phone":98,"phoneExt":58,"email":99},"Patrick Wagner, MD","CONTACT","412-359-3731","patrick.wagner@ahn.org",{"name":101,"role":97,"phone":98,"phoneExt":58,"email":102},"AHN Clinical Trial Contact","clinicaltrials@ahn.org",{"type":104,"investigatorFullName":105,"investigatorTitle":106,"investigatorAffiliation":5,"oldNameTitle":58,"oldOrganization":58},"SPONSOR_INVESTIGATOR","Patrick Wagner, MD, FACS","Director, AHNCI Division of Complex General Surgical Oncology","100658916","phase-2-paricalcitol-versus-pirfenidone-for-improving-surgical-resectability-in-patients-with-peritoneal-cancer-100658916",false,"NCT07856914","Paricalcitol Versus Pirfenidone for Improving Surgical Resectability in Patients With Peritoneal Cancer","A Randomized Phase II Bayesian Pick-the-Winner Clinical Trial Investigating the Efficacy of Fibrosis-Modulating Agents (Paricalcitol and Pirfenidone) in Improving Surgical Resectability in Patients With Peritoneal Carcinomatosis Ineligible for Definitive Cytoreduction (Randy 1A)","RANDY 1A","Inclusion Criteria:\n\n* Males or females, age 18 to \\\u003C81 years at the time of consent\n* Biopsy-proven peritoneal carcinomatosis\n* Documented receipt of at least three months of standard systemic chemotherapy prior to initiation, with persistent disease\n* ECOG Performance Status of 0 or 1\n* Adequate organ function within 14 days prior to anti-fibrotic initiation\n* Negative serum pregnancy test for women of childbearing potential (WOCBP) within 7 days prior to initiation\n* Able to understand and provide written informed consent\n* Willingness and ability to comply with all study procedures\n\nExclusion Criteria:\n\n* Patients deemed eligible for definitive cytoreductive surgery\n\n  * Current or recent (within 30 days) use of paricalcitol, pirfenidone, or Vitamin D supplementation above USDA-recommended daily dosage\n  * Known allergy or medical contraindication to study drugs\n  * Hypersensitivity to any of the study drugs or to any ingredient in the formulation\n  * Receipt of any investigational drug within 30 days prior to initiation\n  * Active pregnancy or lactation\n  * Active smoking\n  * Active brain metastases\n  * Elevated Vitamin D level (\\>2x upper limit of normal)\n  * Significant comorbidities including abnormal calcium\u002Fphosphate, history of serious drug-induced liver injury, severe cardiac conditions, patients with or predisposed to cardiac arrhythmias, or uncontrolled hypertension\n  * Concomitant medications that, after review by the study pharmacist(s) and potential dose modification in accordance with prescribing guidelines, still pose an unmanageable drug-drug interaction or unacceptable safety risk with either study drug","ALL","18 Years","80 Years",{"count":119,"type":120},74,"ESTIMATED","INTERVENTIONAL",[123],"PHASE2","The goal of this clinical trial is to learn if paricalcitol or pirfenidone can help make tumors removable by surgery in adults with peritoneal cancer who are currently unable to have their tumor removed.\n\nThe study aims to answer are whether paricalcitol or pirfenidone improve tumor response and tissue healing after 12 weeks of treatment, and which of these two drugs is more effective at helping participants become eligible for surgery. Researchers will compare paricalcitol to pirfenidone to see which drug works better and has a manageable safety profile.\n\nParticipants will take either paricalcitol or pirfenidone by mouth every day for 12 weeks while continuing their standard chemotherapy, visit the clinic regularly for checkups and lab tests, keep a daily diary to track their study medication, and undergo a surgical re-evaluation after treatment to see if their tumor can be removed.",[126,127,128,129,130,131,132],"Peritoneal (Metastatic) Cancer","Peritoneal Carcinoma","Peritoneal Carcinosis","Peritoneal Cancer","Peritoneal Carcinomatosis","Peritoneal Carcinomatosis From Colorectal or Ovarian Origin","Peritoneal Cavity Cancer",[134,135,136,137,138,82,139,140,141,142,143,144,145,146,147,148],"Peritoneal carcinomatosis","Peritoneal cancer","Peritoneal metastases","Intra-abdominal malignancies","Advanced abdominal cancer with fibrosis","Pirfenidone","Vitamin D analog","Anti-fibrotic therapy","Anti-fibrotic agents","Repurposed drugs in oncology","Surgical resectability","Cytoreductive surgery","Tumor cytoreduction","Tumor microenvironment","Cancer-associated fibroblasts","NOT_YET_RECRUITING","2026-09-28",{"date":152,"type":153},"2026-10-05","ACTUAL",{"date":155,"type":120},"2026-09",{"date":157,"type":120},"2030-11",{"name":105,"class":6}]