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SBRT for Close or Positive Margins After Resection of Pancreatic Adenocarcinoma A Prospective Evaluation in Select Patients With Resected Pancreas Cancer

Phase 2
18 Years
Not Enrolling
Adenocarcinoma of the Pancreas

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Trial Information

SBRT for Close or Positive Margins After Resection of Pancreatic Adenocarcinoma A Prospective Evaluation in Select Patients With Resected Pancreas Cancer

Radiation simulation will be done in Shadyside Radiation Oncology department
Contrast-enhanced CT based simulation will be obtained prior to any adjuvant treatment (2-4
weeks post-op depending on healing). The target volume will be identified based on fiducial
marker placement at time of surgery as well as a detailed discussion and image review with
the operating surgeon. This are will be contoured on axial CT images obtained at 1.25 mm
slice thickness. These volumes will then be reconstructed into a 3-dimensional image set for
SBRT planning. Subjects will be simulated in the treatment position (supine with arms
raised) on the CT scanner table the appropriate immobilization. Optiray® contrast will be
administered intravenously at a flow rate of 2.5 mL/s. A helical CT scan of the abdomen will
be acquired with intravenous contrast starting 30 seconds prior to CT acquisition.

A 4D CT data acquisition for the same axial extent will be obtained. The images will then be
electronically transferred from the CT workstation via DICOM3 to the appropriate treatment
planning workstation in the department of radiation oncology. Based on axial CT images,
fiducial marker placement, review of the pathology report, and a detailed discussion with
the operating surgeon, contours will be drawn of the clinical target volume (CTV), which is
defined as the area at risk for microscopic disease. The planning target volume (PTV) will
be equivalent to the CTV unless motion is detected on the 4D motion study. If there is
motion, the amount of motion in the superior-inferior, lateral, and anterior-posterior
directions will be the margin given. Surrounding normal and critical structures will also be
contoured by the treating radiation oncologist including the kidneys, liver, small bowel,
spinal cord, and stomach if necessary.

Stereotactic Body Radiotherapy Planning An SBRT plan will be created by a medical physicist
based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to
the isodose line best encompassing the PTV.

Careful evaluation of each plan will be conducted by the radiosurgical team to ensure that
normal tissues and critical structures tolerances are maintained.

The maximum dose (in Gy) within the treatment volume (MD), prescriptions dose (PD), and the
ratio of MD/PD (as a measure of heterogeneity within the target volume), prescription
isodose volume (PIV in mm3), tumor volume (TV in mm3), and the ratio of PIV/TV (as a measure
of dose conformity of the treatment relative to the target) will be recorded.

Evaluation during treatment The subjects will be carefully followed while on active
treatment and post-treatment for 24 months, or until death.

Treatment following SBRT All patients will have been seen in a multi-disciplinary pancreatic
cancer clinic. As such, they will be set up with a medical oncologist. Following completion
of SBRT as described in this protocol, the patient's medical oncologist may, at his/her
discretion, administer systemic therapy according to the current standard of care or the
UPMC pathways.

Inclusion Criteria:

- Histologically or cytologically proven adenocarcinoma of the pancreas that has been
resected with a close (<2.5mm) or positive margin based on surgical and pathological

- Subjects will be staged according to the 2010 AJCC staging system (Appendix E) with
pathologic stage T1-4, N0-1 being eligible; and have a primary tumor of the pancreas
(i.e., pancreatic head, neck, uncinate process, body/tail

- PTV must be encompassed in a reasonable SBRT "portal" as defined by the treating
radiation oncologist

- Karnofsky performance status > 70 (ECOG 0-1)

- Age > 18

- Estimated life expectancy > 12 weeks

- Patient must have adequate renal function as defined by serum creatinine<1.5mg/dl
obtained within 28 days prior to registration

- Patient must have adequate hepatic function as defined by total bilirubin <1.5
xIULN(institutional upper limit of normal) and either SGOT or SGPT <2.5xIULN,
obtained within 28 days prior to registration.

- Patient must be able to swallow enteral medications. Patient must not require a
feeding tube. Patient must not have intractable nausea or vomiting, GI tract disease
resulting in an inability to take oral medication, malabsorption syndrome, or
uncontrolled inflammatory bowel disease (Chron's, ulcerative colitis).

- Ability to provide written informed consent

- Patient must not have uncontrolled intercurrent illness including, but not limited
to, ongoing or active infection, symptomatic congestive heart failure, unstable
angina pectoris, cardiac arrhythmia, history of myocardial infarction or
cerebrovascular accident within 3 months prior to registration, uncontrolled
diarrhea, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Patient must not be pregnant because of the risk of harm to the fetus. Nursing women
may participate only if nursing is discontinued, due to the possibility of harm to
nursing infants from the treatment regimen. Women/men of reproductive potential must
agree to use an effective contraception method.

Exclusion Criteria:

- Non-adenocarcinomas, adenosquamous carcinomas, islet cell carcinomas, cystadenomas,
cystadenocarcinomas, carcinoid tumors, duodenal carcinomas, distal bile duct, and
ampullary carcinomas are not eligible.

- Evidence of distant metastasis on upright chest x-ray (CXR), computed tomography (CT)
or other staging studies

- Subjects with recurrent disease

- Prior radiation therapy to the upper abdomen or liver

- Prior chemotherapy

- Subjects in their reproductive age group should use an effective method of birth
control. Subjects who are breast-feeding, or have a positive pregnancy test will be
excluded from the study

- Any co-morbidity or condition of sufficient severity to limit full compliance with
the protocol per assessment by the investigator

- Concurrent serious infection

- Previous or current malignancies of other histologies within the last 5 years, with
the exception of cervical carcinoma in situ, adequately treated basal cell or
squamous cell carcinoma of the skin, and treated low-risk prostate cancer.

Type of Study:


Study Design:

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

Outcome Measure:

To determine the rate of local progression-free survival (LPFS) with two years of follow-up in subjects with margin positive or close margins following resection of pancreatic adenocarcinoma treated with SBRT.

Outcome Description:

In this study, LPFS is defined as the time from enrollment to first documentation of progressive disease (PD) in the target lesion. Death or development of distant disease is not regarded as an event. For patients that undergo surgical resection, local progression will be defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Dwight E Heron, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UPMC Shadyside


United States: Institutional Review Board

Study ID:




Start Date:

July 2011

Completion Date:

June 2015

Related Keywords:

  • Adenocarcinoma of the Pancreas
  • Pancreas
  • Resected
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous



UPMC Shadyside Radiation Oncology Pittsburgh, Pennsylvania  15232