Radiosurgery for Resected Pancreas

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by University of Pittsburgh
Sponsor:
Information provided by (Responsible Party):
Dwight Heron, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01357525
First received: May 18, 2011
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

The current study seeks to further investigate the impact of Stereotactic Body Radiation Therapy following pancreatic resection with a close or positive margin. The investigators hope to improve local control, and through the use of a shortened treatment schedule, allow patients to begin systemic therapy earlier.


Condition Intervention Phase
Adenocarcinoma of the Pancreas
Radiation: Stereotactic Body Radiation Therapy (SBRT)
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: SBRT for Close or Positive Margins After Resection of Pancreatic Adenocarcinoma A Prospective Evaluation in Select Patients With Resected Pancreas Cancer

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • To determine the time to progression (TTP) and overall survival (OS) in this patient population [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    TTP is defined as the time from enrollment to disease progression. Disease progression will be defined as PD in the target volume, or development of distant disease. OS is defined as the length of time from enrollment to confirmed death from any cause.

  • To evaluate the impact of SBRT on the QOL of subjects in the adjuvant setting [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The QOL survey will be the FACT-G and will be administered prior to SBRT, after completion of SBRT, and at each follow-up.

  • To evaluate the acute and late toxicities associated with SBRT for pancreas cancer [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
    All patients will be monitored for potential treatment-related toxicity throughout treatment as detailed in the schema. Toxicity will be graded according to the CTCAE v 4. Acute toxicity is defined as toxicity occurring within 3 months of completion of SBRT. Late toxicity is defined as toxicity occurring greater than 3 months after treatment.


Estimated Enrollment: 50
Study Start Date: July 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Stereotactic Body Radiotherapy Radiation: Stereotactic Body Radiation Therapy (SBRT)

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:

12 Gy x 3 fractions (36 Gy total)

Other Names:
  • CyberKnife
  • Trilogy
  • True Beam
  • Radiosurgery
  • SBRT

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 findings.
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01357525

Contacts
Contact: Dwight E Heron, MD 412-623-6720 herond2@upmc.edu
Contact: Karen D Holeva 412-623-1275 holevakd@upmc.edu

Locations
United States, Pennsylvania
UPMC Shadyside Radiation Oncology Recruiting
Pittsburgh, Pennsylvania, United States, 15232
Contact: Dwight E Heron, MD    412-623-6720    herond2@upmc.edu   
Contact: Rodney Wegner, MD    412-623-6720    wegnerr@upmc.edu   
Sub-Investigator: Steven A Burton, MD         
Sub-Investigator: John Flickinger, MD         
Sub-Investigator: Susan Rakfal, MD         
Sub-Investigator: Cihat Ozhasoglu, PhD         
Sub-Investigator: Annette E Quinn, MSN         
Sub-Investigator: Kenneth Lee, MD         
Sub-Investigator: A. James Moser, MD         
Sub-Investigator: Herbert Zeh, MD         
Sub-Investigator: Alyssa Krasinskas, MD         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Dwight E Heron, MD UPMC Shadyside
Principal Investigator: Rodney Wegner, MD UPMC Shadyside
  More Information

No publications provided

Responsible Party: Dwight Heron, Vice Chairman of Clinical Affairs, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01357525     History of Changes
Other Study ID Numbers: 10-123
Study First Received: May 18, 2011
Last Updated: January 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Pancreas
Resected

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pancreatin
Pancrelipase
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014