Overview

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