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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stereotactic Body Radiotherapy | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic Body Radiation Therapy (SBRT) | Radiation | 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 | Description | Time Frame |
|---|---|---|
| Local Progression-free Survival (LPFS) at 1-year | 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. | Up to 12 months |
| Local Progression-free Survival (LPFS) at 2-years | 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. | Up to 24 months |
| Local Progression-free Survival (LPFS) | 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. | Up to 24 months |
| Regional Progression-free Survival (RPFS) | 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. | Up to 24 months |
| Regional Progression-free Survival (RPFS) at 2-years |
| Measure | Description | Time Frame |
|---|---|---|
| Acute Toxicities Associated With SBRT | 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. | Up to 24 months |
| Late Toxicities Associated With SBRT |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David A Clump, MD | UPMC Hillman Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stereotactic Body Radiotherapy | 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) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients that received treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | Stereotactic Body Radiotherapy | 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) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Local Progression-free Survival (LPFS) at 1-year | 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. | Patients that received study treatment per protocol and were evaluable for response. | Posted | Number | percentage of participants | Up to 12 months |
|
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 Events described per NCI Common Terminology Criteria for Adverse Events (CTCAE) v4.0
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Stereotactic Body Radiotherapy | 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) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abd drain | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Barbara Stadterman, MPH, MCCR, Regulatory Supervisor, CRS | UPMC Hillman Cancer Center | 412-647-5554 | stadtermanbm@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 29, 2011 | Sep 7, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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|
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.
| Up to 24 months |
| Distant Metastasis-free Survival (DMFS) at 2 Years | 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. | Up to 24 months |
| Distant Metastasis-free Survival (DMFS) | Percentage of patients without distant disease metastasis (progression of disease beyond local target lesion). | 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. |
| Up to 24 months |
| 2-year Progression-free Survival (PFS) | 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. | Up to 24 months |
| Time to Progression (TTP) | 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. | Up to 24 months |
| Overall Survival (OS) | The length of time from enrollment to confirmed death from any cause. | Up to 24 months |
| Overall Survival (OS) at 1-year | Percentage of patients alive at 1-year (death from any cause). | Up to 12 months |
| Overall Survival (OS) at 2-years | Percentage of patients alive at 2-years (death from any cause). | Up to 12 months |
| Quality of Life (QoL) FACT-G | 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. | Up to 24 months (before treatment (baseline), shortly after neo-adjuvant treatment, shortly after surgery, shortly after SBRT, shortly after Adjuvant treatment) |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | Local Progression-free Survival (LPFS) at 2-years | 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. | Patients that received study treatment per protocol and were evaluable for response. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 24 months |
|
|
|
| Primary | Local Progression-free Survival (LPFS) | 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. | Patients that received study treatment per protocol and were evaluable for response. | Posted | Median | 95% Confidence Interval | percentage of participants | Up to 24 months |
|
|
|
| Primary | Regional Progression-free Survival (RPFS) | 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. | Patients that received study treatment per protocol and were evaluable for response. | Posted | Number | 95% Confidence Interval | months | Up to 24 months |
|
|
|
| Primary | Regional Progression-free Survival (RPFS) at 2-years | 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. | Patients that received study treatment per protocol and were evaluable for response. | Posted | Median | 95% Confidence Interval | percentage of participants | Up to 24 months |
|
|
|
| Primary | Distant Metastasis-free Survival (DMFS) at 2 Years | 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. | Patients that received study treatment per protocol and were evaluable for response. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 24 months |
|
|
|
| Primary | Distant Metastasis-free Survival (DMFS) | Percentage of patients without distant disease metastasis (progression of disease beyond local target lesion). | Patients that received study treatment per protocol and were evaluable for response. | Posted | Median | 95% Confidence Interval | percentage of participants | Up to 24 months |
|
|
|
| Secondary | Acute Toxicities Associated With SBRT | 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. | Patients that received study treatment per protocol and experienced acute grade 3 þ radiation toxicity. | Posted | Number | percentage of participants | Up to 24 months |
|
|
|
| Secondary | Late Toxicities Associated With SBRT | 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. | Posted | Number | percentage of participants | Up to 24 months |
|
|
|
| Secondary | 2-year Progression-free Survival (PFS) | 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. | Patients that received study treatment per protocol and were evaluable for response. | Posted | Median | 95% Confidence Interval | percentage of participants | Up to 24 months |
|
|
|
| Secondary | Time to Progression (TTP) | 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. | Patients that received study treatment per protocol and were evaluable for response. | Posted | Median | 95% Confidence Interval | months | Up to 24 months |
|
|
|
| Secondary | Overall Survival (OS) | The length of time from enrollment to confirmed death from any cause. | Posted | Median | 95% Confidence Interval | months | Up to 24 months |
|
|
|
| Secondary | Overall Survival (OS) at 1-year | Percentage of patients alive at 1-year (death from any cause). | Posted | Number | percentage of participants | Up to 12 months |
|
|
|
| Secondary | Overall Survival (OS) at 2-years | Percentage of patients alive at 2-years (death from any cause). | Participants enrolled in study. | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 12 months |
|
|
|
| Secondary | Quality of Life (QoL) FACT-G | 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. | Patients that completed FACT-G Quality of Life surveys. | Posted | Median | Inter-Quartile Range | score on a scale | Up to 24 months (before treatment (baseline), shortly after neo-adjuvant treatment, shortly after surgery, shortly after SBRT, shortly after Adjuvant treatment) |
|
|
|
| 25 |
| 49 |
| 0 |
| 49 |
| 23 |
| 49 |
| Abdom pain | Gastrointestinal disorders | Systematic Assessment |
|
| Abx diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Anorexia | Metabolism and nutrition disorders | Systematic Assessment |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment |
|
| Delayed gastric emptying | Gastrointestinal disorders | Systematic Assessment |
|
| Delirium. | Psychiatric disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Dry skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Dysphagia | Gastrointestinal disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Folliculitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| GI bleed | Gastrointestinal disorders | Systematic Assessment |
|
| Hepatic bleeding | Gastrointestinal disorders | Systematic Assessment |
|
| Hair thinning | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hand foot syndrome | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hematoma | Vascular disorders | Systematic Assessment |
|
| HHNK | Metabolism and nutrition disorders | Systematic Assessment |
|
| Hyperglycemia (grade 3) | Metabolism and nutrition disorders | Systematic Assessment |
|
| Leukopenia | Investigations | Systematic Assessment |
|
| Lip herpetic lesion | Gastrointestinal disorders | Systematic Assessment |
|
| Malaise | General disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Neuropathy | Nervous system disorders | Systematic Assessment |
|
| Neutronic fever | General disorders | Systematic Assessment |
|
| Neutropenia | Investigations | Systematic Assessment |
|
| NG tube | Gastrointestinal disorders | Systematic Assessment |
|
| Obstruction (grade 3) | Gastrointestinal disorders | Systematic Assessment |
|
| Pancreatic leak | Hepatobiliary disorders | Systematic Assessment |
|
| PE | Cardiac disorders | Systematic Assessment |
|
| Peripheral neuropathy | Nervous system disorders | Systematic Assessment |
|
| PNA | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pruritis | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Right sided weakness, | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Skin | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| SMA pseudoaneurysm | Nervous system disorders | Systematic Assessment |
|
| SMA pseudocyst | Hepatobiliary disorders | Systematic Assessment |
|
| SMA pseuoanuersym | Nervous system disorders | Systematic Assessment |
|
| SMV thrombus | Vascular disorders | Systematic Assessment |
|
| Strep viridans bacteremia | Infections and infestations | Systematic Assessment |
|
| Thrombocytopenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Thrombotypenia | Blood and lymphatic system disorders | Systematic Assessment |
|
| Upper GI leak | Gastrointestinal disorders | Systematic Assessment |
|
| UTI | Infections and infestations | Systematic Assessment |
|
| Volume depletion | Metabolism and nutrition disorders | Systematic Assessment |
|
| Weight loss | Investigations | Systematic Assessment |
|
| Xerstomia | Gastrointestinal disorders | Systematic Assessment |
|
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| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
|
| Physical well-being (PWB) - Shortly after SBRT |
|
| Physical well-being (PWB) - Shortly after adjuvant treatment |
|
| Social/family well-being (SWB) - Before treatment (baseline) |
|
| Social/family well-being (SWB) - Shortly after neo-adjuvant treatment |
|
| Social/family well-being (SWB) - Shortly after surgery |
|
| Social/family well-being (SWB) - Shortly after SBRT |
|
| Social/family well-being (SWB) - Shortly after adjuvant treatment |
|
| Emotional well-being (EWB) - Before treatment (baseline) |
|
| Emotional well-being (EWB) - Shortly after neo-adjuvant |
|
| Emotional well-being (EWB) -Shortly after surgery |
|
| Emotional well-being (EWB) -Shortly after SBRT |
|
| Emotional well-being (EWB) - Shortly after adjuvant treatment |
|
| Functional well-being (FWB) - Before treatment (baseline) |
|
| Functional well-being (FWB) - Shortly after neo-adjuvant |
|
| Functional well-being -Shortly after surgery |
|
| Functional well-being (FWB) Shortly after SBRT |
|
| Functional well-being (FWB) Shortly after adjuvant treatment |
|
| Total score - Before treatment (baseline) |
|
| Total score - Shortly after neo-adjuvant |
|
| Total score - Shortly after surgery |
|
| Total score - Shortly after SBRT |
|
| Total score - Shortly after adjuvant treatment |
|