Radiosurgery for Resected Pancreas
Adenocarcinoma of the Pancreas
Radiation: Stereotactic Body Radiation Therapy (SBRT)
|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|
- 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.
- 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.
|Study Start Date:||July 2011|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
|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)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01357525
|Contact: Dwight E Heron, MDfirstname.lastname@example.org|
|Contact: Karen D Holevaemail@example.com|
|United States, Pennsylvania|
|UPMC Shadyside Radiation Oncology||Recruiting|
|Pittsburgh, Pennsylvania, United States, 15232|
|Contact: Dwight E Heron, MD 412-623-6720 firstname.lastname@example.org|
|Contact: Rodney Wegner, MD 412-623-6720 email@example.com|
|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|
|Principal Investigator:||Dwight E Heron, MD||UPMC Shadyside|
|Principal Investigator:||Rodney Wegner, MD||UPMC Shadyside|