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

• Status: Recruiting
• Trial end date: 2023-11-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera - Universitaria di Modena; Azienda Ospedaliero-Universitaria di Modena
• Treatments: Gemcitabine; Oxaliplatin

Criteria

Inclusion Criteria:

• Pathologically confirmed adenocarcinoma of the pancreas

• Patients with unresectable disease based on institutional standardized criteria of unresectability or patients whose disease appeared potentially resectable on axial CT imaging 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 surgical bypass prior to starting treatment

• Patients with radiographically assessable disease

• Adequate bone marrow, hepatic and renal function: -Hemoglobin >10.0 g/dL, absolute neutrophil count > 1.5 x 10^9/L, platelet count > 100 x 10^9/L. -Aspartate transaminase (AST or SGOT) and alanine transaminase (ALT or SGPT) should be ≤ 3 x upper limit of normal (ULN). -Total bilirubin < 2 mg/dL. Patients with elevated bilirubin 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 > 40 mL/min (calculated according to Cockroft and Gault)

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 or carcinoma in situ of the cervix, uterus, or bladder