Clinical Trial 20788

• Overview

  Study Title:

  An Advanced MRI Abdomen Protocol to Evaluate Pancreatic Ductal Adenocarcinoma in Surgically Resectable and Borderline Resectable Disease for Loco-Regional Heterogeneity and To Evaluate Treatment Response Status Post Surgery and MRI-GRT

  Summary:

  This is a prospective study evaluating imaging biomarkers in patients with either one of the following profiles: (1) resectable disease who are treated with surgical management (2) borderline resectable pancreatic adenocarcinoma who are treated with MR Guided Radiotherapy with restaging to surgically resectable disease (3) borderline resectable pancreatic adenocarcinoma who are treated with MR Guided Radiotherapy with continued treatment with non-surgical therapy including IRE or chemotherapy alone.

  Objective:

  PROJECT DESCRIPTION This is a prospective study evaluating for imaging biomarkers in patients with either one of the following profiles: (1) resectable disease who are treated with surgical management (2) borderline resectable pancreatic adenocarcinoma who are treated with MR Guided Radiotherapy with restaging to surgically resectable disease.

• Inclusion Criteria

  Inclusion Criteria:
  • Histologically confirmed diagnosis of pancreatic adenocarcinoma.
  • Borderline Resectable Pancreatic Cancer (A. GDA encasement to the hepatic artery allowing: 1. Short segment encasement 2. Abutment without extension to the common hepatic artery. B. Tumor abutment of the SMA or CA (> ECOG Performance Score 0 or 1.
  • Patients must not have had major surgery, monoclonal antibody therapy, or experimental therapy within the 21 days prior to treatment.
  • Women of childbearing potential must have a negative serum or urine pregnancy test.
  • Patients must be able to understand and be willing to sign the written informed consent form. A signed informed consent form must be appropriately obtained prior to the conduct of any trial-specific procedure.
  • Patients must be willing and able to comply with scheduled visits, treatment schedule, laboratory testing, and other study requirements

• Exclusion Criteria

  Exclusion Criteria:
  • Active or clinically significant cardiac disease.
  • Women who are pregnant or breast-feeding.
  • Previous or concurrent cancer within 3 years prior to treatment start EXCEPT for curatively treated cervical cancer in situ, non-melanoma skin cancer, superficial bladder tumors [Ta (non-invasive tumor), Tis (carcinoma in situ) and T1 (tumor invades lamina propria)].
  • Any condition which, in the investigator’s opinion, makes the patient unsuitable for trial participation.
  • Any prior radiation therapy for pancreatic cancer.

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