Last updated: December 8, 2022
Sponsor: Azienda Ospedaliero-Universitaria di Modena
Overall Status: Active - Recruiting
Phase
N/A
Condition
Pancreatic Cancer
Pancreatitis
Pancreatic Disorders
Treatment
N/AClinical Study ID
NCT02416609
BMed1
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Pathologically confirmed adenocarcinoma of the pancreas
- Patients with unresectable disease based on institutional standardized criteria ofunresectability or patients whose disease appeared potentially resectable on axial CTimaging but were found unresectable at surgery
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2. Age ≥ 18
- Patients with biliary or gastroduodenal obstruction must have drainage or surgicalbypass prior to starting treatment
- Patients with radiographically assessable disease
- Adequate bone marrow, hepatic and renal function: -Hemoglobin >10.0 g/dL, absoluteneutrophil count > 1.5 x 10^9/L, platelet count > 100 x 10^9/L. -Aspartatetransaminase (AST or SGOT) and alanine transaminase (ALT or SGPT) should be ≤ 3 xupper limit of normal (ULN). -Total bilirubin < 2 mg/dL. Patients with elevatedbilirubin due to obstruction should be stented and their bilirubin should decrease to < 2 mg/dL prior to study entry. - Creatinine < 3 mg/dL or Creatinine clearance > 40mL/min (calculated according to Cockroft and Gault)
Exclusion
Exclusion Criteria:
- Evidence of metastatic disease in the major viscera or peritoneal seeding or ascites
- Gastric or duodenal obstruction
- Previous peripheral neuropathy
- Previous irradiation to the planned field; previous chemotherapy for pancreatic cancer
- Malignancy (within the past two years) except non-melanomatous skin cancer orcarcinoma in situ of the cervix, uterus, or bladder
Study Design
Total Participants: 44
Study Start date:
January 01, 2014
Estimated Completion Date:
November 30, 2024
Connect with a study center
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, MO 41121
ItalyActive - Recruiting
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