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Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Unresectable Pancreatic Cancer


Phase 4
18 Years
N/A
Not Enrolling
Both
Pancreatic Cancer

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Trial Information

Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy (SBRT) for the Treatment of Unresectable Pancreatic Cancer


This is a single institution, non-randomized, prospective, phase IV trial of SBRT for
unresectable pancreatic cancer.

Data collected will include patient demographics, pathology data, tumor stage, SBRT dose
fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence
data, and acute and late toxicities.

Follow up data will be collected during the patient's standard office visits. The
anticipated duration of this study is 5 years.


Inclusion Criteria:



- Patient age >= 18 years

- Zubrod performance status of 0-3

- Unresectable pancreatic cancer

- Maximum tumor diameter < 7.5 cm

- Signed study-specific consent form

Exclusion Criteria:

- Maximum tumor diameter > 7.5 cm

- Prior radiotherapy to the upper abdomen

- Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown
effects of RT on lactating females

- Patients with psychiatric or addictive disorder that would preclude obtaining
informed consent

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

local control rate

Outcome Description:

Local recurrence is defined as tumor recurrence within the planning target volume. Local control rate will be evaluated by imaging techniques such as CT or MRI. Local recurrence will be defined as an increase of > 20% in tumor size. If necessary, a PET/CT scan may be used to aid in diagnoses of local tumor recurrence.

Outcome Time Frame:

5 years

Safety Issue:

No

Authority:

United States: Institutional Review Board

Study ID:

08-060

NCT ID:

NCT01346410

Start Date:

September 2008

Completion Date:

July 2012

Related Keywords:

  • Pancreatic Cancer
  • pancreatic cancer
  • Pancreatic Neoplasms

Name

Location

St. John's Mercy Medical CenterSaint Louis, Missouri  63141