SBRT for Close or Positive Margins After Resection of Pancreatic Adenocarcinoma

• Sponsor: David A. Clump, MD, PhD (Other)
• Overall Status: Completed
• CT.gov ID: NCT01357525
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Actual Duration (Months): 63.8
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	Phase
Adenocarcinoma of the Pancreas	Radiation: Stereotactic Body Radiation Therapy (SBRT)	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (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
• Actual Study Start Date: Feb 6, 2013
• Actual Primary Completion Date: Apr 1, 2018
• Actual Study Completion Date: Jun 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Outcome Measures

Primary Outcome Measures

1. Local Progression-free Survival (LPFS) at 1-year [Up to 12 months]

   Percentage of patients that did not experience progressive disease (PD) in the target lesion. Death or development of distant disease was not regarded as an event. For patients that underwent surgical resection, local progression was defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.

2. Local Progression-free Survival (LPFS) at 2-years [Up to 24 months]

   Percentage of patients that did not experience progressive disease (PD) in the target lesion. Death or development of distant disease was not regarded as an event. For patients that underwent surgical resection, local progression was defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.

3. Local Progression-free Survival (LPFS) [Up to 24 months]

   Percentage of patients without disease progression in target lesion from time from enrollment until one month. 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.

4. Regional Progression-free Survival (RPFS) [Up to 24 months]

   Time duration that patients that did not experience progressive disease (PD) in the target lesion. Death or development of distant disease was not regarded as an event. For patients that underwent surgical resection, local progression was defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.

5. Regional Progression-free Survival (RPFS) at 2-years [Up to 24 months]

   Percentage of patients that did not experience progressive disease (PD) in the target lesion. Death or development of distant disease was not regarded as an event. For patients that underwent surgical resection, local progression was defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.

6. Distant Metastasis-free Survival (DMFS) at 2 Years [Up to 24 months]

   Percentage of patients that did not experience distant metastasis. Death or development of distant disease was not regarded as an event. For patients that underwent surgical resection, local progression was defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.

7. Distant Metastasis-free Survival (DMFS) [Up to 24 months]

   Percentage of patients without distant disease metastasis (progression of disease beyond local target lesion).

Secondary Outcome Measures

1. Acute Toxicities Associated With SBRT [Up to 24 months]

   Percentage of patients that experienced acute toxicity (defined as toxicity occurring within 3 months of completion of SBRT). Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v 4.

2. Late Toxicities Associated With SBRT [Up to 24 months]

   Percentage of patients that experienced late toxicity (defined as toxicity occurring after 3 months of completion of SBRT). Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v 4.

3. 2-year Progression-free Survival (PFS) [Up to 24 months]

   Percentage of patients that did not experience disease progression at 2 years. 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.

4. Time to Progression (TTP) [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.

5. Overall Survival (OS) [Up to 24 months]

   The length of time from enrollment to confirmed death from any cause.

6. Overall Survival (OS) at 1-year [Up to 12 months]

   Percentage of patients alive at 1-year (death from any cause).

7. Overall Survival (OS) at 2-years [Up to 12 months]

   Percentage of patients alive at 2-years (death from any cause).

8. Quality of Life (QoL) FACT-G [Up to 24 months (before treatment (baseline), shortly after neo-adjuvant treatment, shortly after surgery, shortly after SBRT, shortly after Adjuvant treatment)]

   The FACT-G is a 27 item questionnaire that assesses physical, social/family, emotional, and functional well-being, 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	UPMC Hillman Cancer Center	Pittsburgh	Pennsylvania	United States	15232

Sponsors and Collaborators

• David A. Clump, MD, PhD

Investigators

• Principal Investigator: David A Clump, MD, UPMC Hillman Cancer Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jun 29, 2011

More Information

Publications

None provided.

• Responsible Party: David A. Clump, MD, PhD, Assistant Professor, Radiation Oncology, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT01357525
• Other Study ID Numbers: HCC 10-123
• First Posted: May 20, 2011
• Last Update Posted: Nov 24, 2021
• Last Verified: Oct 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by David A. Clump, MD, PhD, Assistant Professor, Radiation Oncology, University of Pittsburgh: Pancreas; Resected
• Additional relevant MeSH terms: Adenocarcinoma

Study Results

Participant Flow

Arm/Group Title	Stereotactic Body Radiotherapy
Arm/Group Description	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)
Period Title: Overall Study
STARTED	50
COMPLETED	49
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Stereotactic Body Radiotherapy
Arm/Group Description	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)
Overall Participants	50
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	69.9
Sex: Female, Male (Count of Participants)
Female	24 48%
Male	26 52%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 2%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 2%
White	48 96%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Local Progression-free Survival (LPFS) at 1-year
Description	Percentage of patients that did not experience progressive disease (PD) in the target lesion. Death or development of distant disease was not regarded as an event. For patients that underwent surgical resection, local progression was defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

Patients that received study treatment per protocol and were evaluable for response.

Arm/Group Title	Stereotactic Body Radiotherapy
Arm/Group Description	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)
Measure Participants	43
Number [percentage of participants]	85 170%

2. Primary Outcome

Title	Local Progression-free Survival (LPFS) at 2-years
Description	Percentage of patients that did not experience progressive disease (PD) in the target lesion. Death or development of distant disease was not regarded as an event. For patients that underwent surgical resection, local progression was defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.
Time Frame	Up to 24 months

Outcome Measure Data

Analysis Population Description

Patients that received study treatment per protocol and were evaluable for response.

Arm/Group Title	Stereotactic Body Radiotherapy
Arm/Group Description	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)
Measure Participants	43
Number (95% Confidence Interval) [percentage of participants]	78.12 156.2%

3. Primary Outcome

Title	Local Progression-free Survival (LPFS)
Description	Percentage of patients without disease progression in target lesion from time from enrollment until one month. 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 Frame	Up to 24 months

Outcome Measure Data

Analysis Population Description

Patients that received study treatment per protocol and were evaluable for response.

Arm/Group Title	Stereotactic Body Radiotherapy
Arm/Group Description	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)
Measure Participants	49
Median (95% Confidence Interval) [percentage of participants]	NA NaN

4. Primary Outcome

Title	Regional Progression-free Survival (RPFS)
Description	Time duration that patients that did not experience progressive disease (PD) in the target lesion. Death or development of distant disease was not regarded as an event. For patients that underwent surgical resection, local progression was defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.
Time Frame	Up to 24 months

Outcome Measure Data

Analysis Population Description

Patients that received study treatment per protocol and were evaluable for response.

Arm/Group Title	Stereotactic Body Radiotherapy
Arm/Group Description	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)
Measure Participants	49
Number (95% Confidence Interval) [months]	NA

5. Primary Outcome

Title	Regional Progression-free Survival (RPFS) at 2-years
Description	Percentage of patients that did not experience progressive disease (PD) in the target lesion. Death or development of distant disease was not regarded as an event. For patients that underwent surgical resection, local progression was defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.
Time Frame	Up to 24 months

Outcome Measure Data

Analysis Population Description

Patients that received study treatment per protocol and were evaluable for response.

Arm/Group Title	Stereotactic Body Radiotherapy
Arm/Group Description	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)
Measure Participants	49
Median (95% Confidence Interval) [percentage of participants]	72.2 144.4%

6. Primary Outcome

Title	Distant Metastasis-free Survival (DMFS) at 2 Years
Description	Percentage of patients that did not experience distant metastasis. Death or development of distant disease was not regarded as an event. For patients that underwent surgical resection, local progression was defined as disease recurrence detected on follow-up imaging (CT or FDG-PET/CT) that is located within the SBRT target volume.
Time Frame	Up to 24 months

Outcome Measure Data

Analysis Population Description

Patients that received study treatment per protocol and were evaluable for response.

Arm/Group Title	Stereotactic Body Radiotherapy
Arm/Group Description	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)
Measure Participants	49
Number (95% Confidence Interval) [percentage of participants]	49.69 99.4%

7. Primary Outcome

Title	Distant Metastasis-free Survival (DMFS)
Description	Percentage of patients without distant disease metastasis (progression of disease beyond local target lesion).
Time Frame	Up to 24 months

Outcome Measure Data

Analysis Population Description

Patients that received study treatment per protocol and were evaluable for response.

Arm/Group Title	Stereotactic Body Radiotherapy
Arm/Group Description	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)
Measure Participants	49
Median (95% Confidence Interval) [percentage of participants]	21 42%

8. Secondary Outcome

Title	Acute Toxicities Associated With SBRT
Description	Percentage of patients that experienced acute toxicity (defined as toxicity occurring within 3 months of completion of SBRT). Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v 4.
Time Frame	Up to 24 months

Outcome Measure Data

Analysis Population Description

Patients that received study treatment per protocol and experienced acute grade 3 þ radiation toxicity.

Arm/Group Title	Stereotactic Body Radiotherapy
Arm/Group Description	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)
Measure Participants	49
Number [percentage of participants]	4.1 8.2%

9. Secondary Outcome

Title	Late Toxicities Associated With SBRT
Description	Percentage of patients that experienced late toxicity (defined as toxicity occurring after 3 months of completion of SBRT). Toxicities were graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v 4.
Time Frame	Up to 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stereotactic Body Radiotherapy
Arm/Group Description	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)
Measure Participants	49
Number [percentage of participants]	0 0%

10. Secondary Outcome

Title	2-year Progression-free Survival (PFS)
Description	Percentage of patients that did not experience disease progression at 2 years. 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 Frame	Up to 24 months

Outcome Measure Data

Analysis Population Description

Patients that received study treatment per protocol and were evaluable for response.

Arm/Group Title	Stereotactic Body Radiotherapy
Arm/Group Description	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)
Measure Participants	49
Median (95% Confidence Interval) [percentage of participants]	32.79 65.6%

11. Secondary Outcome

Title	Time to Progression (TTP)
Description	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.
Time Frame	Up to 24 months

Outcome Measure Data

Analysis Population Description

Patients that received study treatment per protocol and were evaluable for response.

Arm/Group Title	Stereotactic Body Radiotherapy
Arm/Group Description	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)
Measure Participants	49
Median (95% Confidence Interval) [months]	12

12. Secondary Outcome

Title	Overall Survival (OS)
Description	The length of time from enrollment to confirmed death from any cause.
Time Frame	Up to 24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stereotactic Body Radiotherapy
Arm/Group Description	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)
Measure Participants	50
Median (95% Confidence Interval) [months]	18

13. Secondary Outcome

Title	Overall Survival (OS) at 1-year
Description	Percentage of patients alive at 1-year (death from any cause).
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Stereotactic Body Radiotherapy
Arm/Group Description	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)
Measure Participants	50
Number [percentage of participants]	68 136%

14. Secondary Outcome

Title	Overall Survival (OS) at 2-years
Description	Percentage of patients alive at 2-years (death from any cause).
Time Frame	Up to 12 months

Outcome Measure Data

Analysis Population Description

Participants enrolled in study.

Arm/Group Title	Stereotactic Body Radiotherapy
Arm/Group Description	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)
Measure Participants	50
Number (95% Confidence Interval) [percentage of participants]	39.95 79.9%

15. Secondary Outcome

Title	Quality of Life (QoL) FACT-G
Description	The FACT-G is a 27 item questionnaire that assesses physical, social/family, emotional, and functional well-being, 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.
Time Frame	Up to 24 months (before treatment (baseline), shortly after neo-adjuvant treatment, shortly after surgery, shortly after SBRT, shortly after Adjuvant treatment)

Outcome Measure Data

Analysis Population Description

Patients that completed FACT-G Quality of Life surveys.

Arm/Group Title	Stereotactic Body Radiotherapy
Arm/Group Description	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)
Measure Participants	22
Physical well-being (PWB) - Before treatment (baseline)	24
Physical well-being (PWB) - Shortly after neo-adjuvant treatment	25
Physical well-being (PWB) - Shortly after surgery	24
Physical well-being (PWB) - Shortly after SBRT	23
Physical well-being (PWB) - Shortly after adjuvant treatment	18
Social/family well-being (SWB) - Before treatment (baseline)	26
Social/family well-being (SWB) - Shortly after neo-adjuvant treatment	28
Social/family well-being (SWB) - Shortly after surgery	25
Social/family well-being (SWB) - Shortly after SBRT	26
Social/family well-being (SWB) - Shortly after adjuvant treatment	17
Emotional well-being (EWB) - Before treatment (baseline)	17
Emotional well-being (EWB) - Shortly after neo-adjuvant	22
Emotional well-being (EWB) -Shortly after surgery	20
Emotional well-being (EWB) -Shortly after SBRT	21
Emotional well-being (EWB) - Shortly after adjuvant treatment	14
Functional well-being (FWB) - Before treatment (baseline)	14
Functional well-being (FWB) - Shortly after neo-adjuvant	20
Functional well-being -Shortly after surgery	22
Functional well-being (FWB) Shortly after SBRT	13
Functional well-being (FWB) Shortly after adjuvant treatment	17
Total score - Before treatment (baseline)	83
Total score - Shortly after neo-adjuvant	94
Total score - Shortly after surgery	85
Total score - Shortly after SBRT	78
Total score - Shortly after adjuvant treatment	64

Adverse Events

Time Frame	Adverse event data were collected were collected for patients up to 24 month after initiation of treatment. All-Cause Mortality monitored for up to 48 months.
Adverse Event Reporting Description	Adverse Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
Arm/Group Title	Stereotactic Body Radiotherapy
Arm/Group Description	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)
All Cause Mortality
	Stereotactic Body Radiotherapy
	Affected / at Risk (%)	# Events
Total	25/49 (51%)
Serious Adverse Events
	Stereotactic Body Radiotherapy
	Affected / at Risk (%)	# Events
Total	0/49 (0%)
Other (Not Including Serious) Adverse Events
	Stereotactic Body Radiotherapy
	Affected / at Risk (%)	# Events
Total	23/49 (46.9%)
Blood and lymphatic system disorders
Thrombocytopenia	1/49 (2%)
Thrombotypenia	1/49 (2%)
Cardiac disorders
PE	1/49 (2%)
Gastrointestinal disorders
Abd drain	1/49 (2%)
Abdom pain	3/49 (6.1%)
Abx diarrhea	1/49 (2%)
Delayed gastric emptying	2/49 (4.1%)
Diarrhea	3/49 (6.1%)
Dysphagia	1/49 (2%)
GI bleed	1/49 (2%)
Hepatic bleeding	1/49 (2%)
Lip herpetic lesion	1/49 (2%)
Nausea	1/49 (2%)
NG tube	1/49 (2%)
Obstruction (grade 3)	1/49 (2%)
Upper GI leak	1/49 (2%)
Xerstomia	1/49 (2%)
General disorders
Fatigue	8/49 (16.3%)
Fever	1/49 (2%)
Malaise	1/49 (2%)
Neutronic fever	1/49 (2%)
Hepatobiliary disorders
Pancreatic leak	1/49 (2%)
SMA pseudocyst	1/49 (2%)
Infections and infestations
Strep viridans bacteremia	1/49 (2%)
UTI	2/49 (4.1%)
Investigations
Leukopenia	1/49 (2%)
Neutropenia	2/49 (4.1%)
Weight loss	2/49 (4.1%)
Metabolism and nutrition disorders
Anorexia	1/49 (2%)
Dehydration	2/49 (4.1%)
HHNK	1/49 (2%)
Hyperglycemia (grade 3)	1/49 (2%)
Volume depletion	1/49 (2%)
Musculoskeletal and connective tissue disorders
Right sided weakness,	1/49 (2%)
Nervous system disorders
Neuropathy	1/49 (2%)
Peripheral neuropathy	1/49 (2%)
SMA pseudoaneurysm	1/49 (2%)
SMA pseuoanuersym	1/49 (2%)
Psychiatric disorders
Delirium.	1/49 (2%)
Respiratory, thoracic and mediastinal disorders
PNA	2/49 (4.1%)
Skin and subcutaneous tissue disorders
Dry skin	1/49 (2%)
Folliculitis	1/49 (2%)
Hair thinning	1/49 (2%)
Hand foot syndrome	1/49 (2%)
Pruritis	2/49 (4.1%)
Rash	2/49 (4.1%)
Skin	1/49 (2%)
Vascular disorders
Hematoma	1/49 (2%)
SMV thrombus	1/49 (2%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.