Chemotherapy Plus Proton-chemotherapy for Locally Advanced Pancreatic Cancer

Stopped early · Not applicable

Conditions studied: Pancreatic Cancer

In brief

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.

Key facts

Study ID

NCT01683422

Run by

Loma Linda University

People needed

9

Starts

2013-01-02

Expected to finish

2019-02-19

Last updated by the study team

2021-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Histologically or cytologically confirmed unresectable non-metastatic adenocarcinoma of the pancreas
• The American Joint Committee on Cancer (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:
• No evidence of tumor extension to the celiac axis, hepatic artery or superior mesenteric artery.
• No evidence of tumor encasement or occlusion of the superior mesenteric vein (SMV) or the SMV/portal vein confluence
• 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
• White Blood Cell (WBC) > 2,000 cells/mm3
• Absolute Neutrophil Count (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
• Alanine aminotransferase (ALT) < 3 times ULN
• Aspartate transaminase (AST) < 3 times ULN
• Albumin > 3.2 g/dl
• Patient must sign study-specific informed consent

You may not qualify if…

• AJCC stage IV with metastatic disease
• Eastern Cooperative Oncology Group performance status of > 2
• Age < 18 years
• 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

Where it is running

• Loma Linda University Medical Center — Loma Linda, California, United States

Full record on ClinicalTrials.gov

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