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Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer

Thank you

Trial Information

Gemcitabine/Abraxane Chemotherapy and Dose Escalated Radiotherapy for Locally Advanced, Unresectable Pancreatic Cancer


The long term goal is to improve survival of patients with unresectable pancreatic cancer.
Additional potential benefits include increased probability of local control and decreased
distant metastases.


Inclusion Criteria:



- Histologically or cytologically proven carcinoma of the pancreas that is locally
advanced

- ECOG performance status 0- 2

- Adequate labs

- No prior abdominal radiation therapy

- No other concurrent clinically evident malignancy, except inactive nonmelanoma skin
cancer, inactive cervical cancer, or other cancer for which the patient has been
disease-free for 5 years

- All disease must be encompassed within a radiotherapy portal

- Not pregnant or nursing

Exclusion Criteria:

- Patient has metastatic disease on radiological staging

- systemic therapy.

- Patient has known active infection with HIV, hepatitis C or hepatitis B

- Patient has serious medical risk factors involving any of the major organ systems
such that the Investigator considers it unsafe for the patient to receive an
experimental research drug.

- Patient is deemed to be have obvious resectable disease at presentation

- Received any investigational agent within a month prior to enrollment.

- Neuroendocrine tumors of the pancreas

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Increase overall survival

Outcome Description:

Estimated increase in median survival from 11 to 16 months

Outcome Time Frame:

23 months

Safety Issue:

No

Principal Investigator

Olugbenga Olowokure, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Cincinnati

Authority:

United States: Institutional Review Board

Study ID:

UCC-GI-01

NCT ID:

NCT01693276

Start Date:

September 2012

Completion Date:

March 2020

Related Keywords:

  • Pancreatic Cancer
  • pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

University of CincinnatiCincinnati, Ohio  45267-0502