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A Multi-Institutional Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer


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

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Trial Information

A Multi-Institutional Phase II Study of Neoadjuvant Gemcitabine and Oxaliplatin With Radiation Therapy in Patients With Pancreatic Cancer


Inclusion Criteria:



- Patients must have cytologic or histologic confirmation of carcinoma arising in the
pancreas.

- Patients must be deemed resectable or borderline resectable based on criteria in
section 4.2 prior to registration.

- Patients must have an expected life expectancy of at least 12 weeks and a Zubrod
performance status of < 2.

- Patients must have adequate organ function defined as follows: absolute neutrophil
count of > 1500/mm3, platelets > 100,000/mm3, serum Cr < 1.5 mg/dl, total bilirubin <
3.0 mg/dl with relief of biliary obstruction if present (PTC tube or endobiliary
stent).

- Patients must be free of other active systemic malignancy, ongoing infection,
including HIV infection, or any other serious uncontrolled, concomitant systemic
disorders or psychiatric condition that would interfere with the safe delivery of
protocol therapy.

- Patients must be aware of the investigational nature of the therapy and provide
written informed consent.

- Patients must have no history of previous chemotherapy for pancreatic cancer or any
abdominal radiation therapy.

- Patients must not have used any investigational agent in the month before enrollment
into the study.

Exclusion Criteria:

- Patients with neuroendocrine tumors are excluded.

- Patients with preexisting peripheral neuropathy > grade 2 are ineligible.

- Pregnant or nursing women are ineligible and patients of reproductive potential must
agree to use an effective contraceptive method during participation in this trial and
for 6 months after trial.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Two-year disease free survival.

Outcome Time Frame:

two years

Safety Issue:

No

Principal Investigator

Mark Zalupski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan

Authority:

United States: Institutional Review Board

Study ID:

UMCC 2006.025

NCT ID:

NCT00456599

Start Date:

April 2007

Completion Date:

December 2015

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Neoplasms

Name

Location

Johns Hopkins UniversityBaltimore, Maryland  21205
University of MichiganAnn Arbor, Michigan  48109-0624
Ohio State UniversityColumbus, Ohio  43210