Low-dose Radiotherapy as a Chemo-potentiator of a Induction Chemotherapy Regimen With Gem-based Doublets and Stereotactic Body Radiotherapy for Locally Advanced Pancreatic Cancer
Overview
- Phase
- Not Applicable
- Intervention
- LDR
- Conditions
- Pancreatic Cancer
- Sponsor
- Azienda Ospedaliero-Universitaria di Modena
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Progression-free survival
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief 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).
Investigators
Bruno Meduri
Medical Doctor
Azienda Ospedaliero-Universitaria di Modena
Eligibility 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 ≤
- •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
Arms & Interventions
Gem-based doublets with LDR & sequential SBRT
Four Gem-based doublets cycles will be administered concurrent with LDR. If no progression, three fractions of SBRT will be administered.
Intervention: LDR
Gem-based doublets with LDR & sequential SBRT
Four Gem-based doublets cycles will be administered concurrent with LDR. If no progression, three fractions of SBRT will be administered.
Intervention: Gem-based doublets
Gem-based doublets with LDR & sequential SBRT
Four Gem-based doublets cycles will be administered concurrent with LDR. If no progression, three fractions of SBRT will be administered.
Intervention: SBRT
Outcomes
Primary Outcomes
Progression-free survival
Time Frame: 1 year
defined as the time from the initiation of therapy to the time of first event (local, regional or distant progression or death due to any cause). Patients without any such event at the time of data analysis will be censored at the last date they were known to be event-free. Patients with no tumor assessments after baseline will be censored at day 1
Secondary Outcomes
- Overall survival(1 year)
- Toxicity(scored according to the National Cancer Institute Common Terminology Criteria for Adverse Events (v4.0))(every 3 months, up to 1 year)