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A Phase I/II Radiation Dose-Escalation Study of Intensity-Modulated Radiotherapy (IMRT) With Concurrent Gemcitabine in Patients With Unresectable Pancreatic Cancer


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

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Trial Information

A Phase I/II Radiation Dose-Escalation Study of Intensity-Modulated Radiotherapy (IMRT) With Concurrent Gemcitabine in Patients With Unresectable Pancreatic Cancer


Inclusion Criteria:



- Is the patient 18 years of age or older.

- Does the patient have histologically or cytologically proven carcinoma of the
pancreas

- Is the tumor unresectable or medically inoperable

- Does the patient have a Zubrod performance status of ≤ 2 (appendix I).

- Does the patient have an absolute neutrophil count of ≥ 1500/mm3, and platelets ≥
100,000/mm3

- Does the patient have adequate renal function (creatinine < 2 mg/dl) and hepatic
function (bilirubin < 3 mg/dl), with relief of biliary obstruction if present

- Is the patient free of significant co-morbid conditions that would preclude safe
administration or completion of protocol therapy

- If the patient is of reproductive potential, has he or she agreed to use an effective
method of contraception during treatment on this trial and for 6 months after
treatment

- Is the patient aware of the investigational nature of the therapy such that they can
provide written informed consent

Exclusion Criteria:

- Does the patient have a neuroendocrine tumor of the pancreas

- Does the patient have metastatic disease

- Does the patient have a history of abdominal radiation therapy

- Is there history of more than 1 month of therapy with single agent gemcitabine

- Has the patient used any investigational agent in the month before enrollment into
the study

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the maximum tolerated radiation dose delivered with intensity-modulated radiotherapy (IMRT) and concurrent gemcitabine in patients with unresectable adenocarcinoma of the pancreas.

Outcome Time Frame:

on tmt and up to 13 week post radiation follow-up/and 18m subsequent to this

Safety Issue:

Yes

Principal Investigator

Mark Zalupski, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Michigan

Authority:

United States: Institutional Review Board

Study ID:

UMCC 2006.018

NCT ID:

NCT00593866

Start Date:

June 2006

Completion Date:

June 2015

Related Keywords:

  • Pancreatic Cancer
  • Patients who have confirmed cancer arising from the pancreas
  • Pancreatic Neoplasms

Name

Location

University of MichiganAnn Arbor, Michigan  48109-0624
Rush University Medical CenterChicago, Illinois  60612-3824