Radiosurgery for Resected Pancreas
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|ClinicalTrials.gov Identifier: NCT01357525|
Recruitment Status : Completed
First Posted : May 20, 2011
Last Update Posted : February 10, 2021
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Pancreas||Radiation: Stereotactic Body Radiation Therapy (SBRT)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||SBRT for Close or Positive Margins After Resection of Pancreatic Adenocarcinoma A Prospective Evaluation in Select Patients With Resected Pancreas Cancer|
|Actual Study Start Date :||February 6, 2013|
|Actual Primary Completion Date :||April 1, 2018|
|Actual Study Completion Date :||June 1, 2018|
|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)
- Local progression-free survival (LPFS) [ Time Frame: Up to 24 months ]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.
- Time to Progression (TTP) [ Time Frame: Up to 24 months ]The time from enrollment to disease progression. 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.
- Overall Survival (OS) [ Time Frame: Up to 24 months ]The length of time from enrollment to confirmed death from any cause.
- Acute toxicities associated with SBRT [ Time Frame: Up to 24 months ]Toxicities will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v 4. Acute toxicity is defined as toxicity occurring within 3 months of completion of SBRT.
- Late toxicities associated with SBRT [ Time Frame: Up to 24 months ]Toxicities will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v 4. Late toxicity is defined as toxicity occurring greater than 3 months after treatment.
- Quality of Life (QoL) FACT-G [ Time Frame: Up to 24 months ]The FACT-G is a 27 item questionnaire that assesses physical, social/family, emotional, and functional well-being. will be provided to patients and self-administered prior to SBRT, after completion of SBRT, and at each follow-up. The survey takes 5 minutes to complete and employs as five-point scale from 0 (not at all) to 4 (very much). Subscale scores added to obtain total score. Scoring range is between 0-108 points. Negatively worded items are reverse scored prior to summing so that higher subscale and total scores indicate better QoL.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01357525
|United States, Pennsylvania|
|UPMC Hillman Cancer Center|
|Pittsburgh, Pennsylvania, United States, 15232|
|Principal Investigator:||David A Clump, MD||UPMC Hillman Cancer Center|