Chemotherapy Plus Proton-chemotherapy for Locally Advanced Pancreatic Cancer
Conditions
Pancreatic Cancer
Conditions: official terms
Pancreatic Neoplasms
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Proton, Gemcitabine, Erlotinib, Capecitabine Type: Radiation
Name: Proton Radiation Type: Radiation
Overall Status
Recruiting
Summary
The current trial will provide important data on the recurrence rates and patterns of failure using state of the art target agent, chemotherapy and proton beam technology for patients with Locally Advanced Pancreatic Cancer (LAPC). A median survival of 10 months or greater would be considered evidence of a regimen potentially worthy of further study as a new treatment paradigm in one arm in a future phase III trial.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:

- Histologically or cytologically confirmed unresectable non-metastatic adenocarcinoma of the pancreas

- AJCC stage I-III with unresectable or borderline unresectable disease as defined by NCCN guidelines

- Radiological resectability is defined by the following criteria on abdominal imaging:

1. No evidence of tumor extension to the celiac axis, hepatic artery or superior mesenteric artery.

2. No evidence of tumor encasement or occlusion of the superior mesenteric vein (SMV) or the SMV/portal vein confluence

3. No evidence of visceral or peritoneal metastases

- Borderline and Unresectable cases would be defined as those that do not meet the criteria in section and also show no evidence of distant metastatic or intraperitoneal disease.

- Eastern Cooperative Oncology Group performance status of ≤ 2

- Age > 18 years

- Adequate hematologic reserve, hepatic reserve and renal function

- WBC > 2,000 cells/mm3

- ANC > 1,500 cells/mm3

- Platelets > 100,000 cells/mm3

- Serum bilirubin ≤ 2.5 mg/dL

- Serum creatinine ≤ 2 x upper limit of normal (ULN), or creatinine clearance (Ccr) ≥ 30ml/min

- ALT < 3 times ULN

- AST < 3 times ULN

- Albumin > 3.2 g/dl

- Patient must sign study-specific informed consent
Location
Loma Linda University Medical Center
Loma Linda, California, United States
Status: Recruiting
Contact: Gary Yang, MD - 909-558-4280 - gyang@llu.edu
Start Date
December 2011
Completion Date
December 2020
Sponsors
Loma Linda University
Source
Loma Linda University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page