Low-dose Radiotherapy Plus Chemotherapy With Gem-based Doublets and Stereotactic Radiotherapy for Advanced Pancreatic Cancer

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/A

Clinical Study ID

NCT02416609
BMed1
  • Ages > 18
  • All Genders

Study Summary

Aim of this study is to evaluate if low-dose radiotherapy (LDR) can intensify local effect of a chemotherapy regimen with Gem-based doublets administered sequentially with stereotactic body radiotherapy (SBRT) and to assess the safety and efficacy of this combined treatment on patients affected by locally advanced pancreatic adenocarcinoma (LAPC).

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
    Italy

    Active - Recruiting

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