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SWOG S1505

Trial

Clinical Trial Title

SWOG S1505

Trial Status

Open to Enrollment

Start Date

July 20, 2017

Location

Trial Type

Cancer (Oncology)

Specific Condition

Pancreatic Adenocarcinoma

Description

A Randomized Phase II Study of Perioperative mFOLFIRINOX Versus Gemcitabine/Nab-Paclitaxel as Therapy for Resectable Pancreatic Adenocarcinoma

Eligibility Criteria

  • Patients must have histologically or cytologically proven pancreatic adenocarcinoma. Histologies other than adenocarcinoma, or any mixed histologies, will NOT be eligible
  • Patients must be > 18 and < 75 years old
  • Patients must have a Zubrod Performance Status of 0-1
  • Patients must have measurable disease in the pancreas. CT scans or MRIs used to assess measurable disease must have been completed within 28 days prior to registration
  • Patients must have resectable primary tumor based on contrast-enhanced CT or MRI of the chest, abdomen, and pelvis. Resectable is defined as:
  •     No involvement of the celiac artery, common hepatic artery, and superior mesenteric artery (and, if present, replaced right hepatic artery)
  •     No involvement, or < 180° interface between tumor and vessel wall, of the portal vein and/or superior mesenteric vein; and patent portal vein/splenic vein confluence
  •     No evidence of metastatic disease. Lymphadenopathy (defined as nodes measuring > 1cm in short axis) outside the surgical basin (i.e., para-aortic, peri-caval, celiac axis, or distant nodes) is considered M1 disease and makes the patient ineligible. If, however, such nodes are biopsied and are negative, then enrollment can be considered after review with the study chairs
  • Patients must have surgical consult to verify patient is a surgical candidate within 21 days prior to registration
  • Patients must not have received prior surgery, radiation therapy, chemotherapy, targeted therapy, or any investigational therapy for pancreatic cancer
  • No prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer, in situ breast (ductal or lobular) cancer, or other cancer for which the patient has been disease and treatment-free for two years

Please contact Legacy Oncology Research for additional study inclusion/exclusion information.

IRB Number

Central IRB

Principal Investigator Name

Jacqueline Vuky, MD

Contact Name

Oncology Clinical Research

Phone

503-413-8199

Contact Fax

503-413-6920

Contact E-Mail

oncologyresearch@lhs.org

Last Updated: Thursday, December 28, 2017 12:53:06 PM