SBRT for Close or Positive Margins After Resection of Pancreatic Adenocarcinoma

NCT01357525 | Completed Results DMC FDA Device

• 1 other identifier: HCC 10-123
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenocarcinoma of the Pancreas

Keywords

Pancreas; Resected

Outcome Measures

Primary Outcomes (7)

• 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

  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

Secondary Outcomes (8)

• Acute Toxicities Associated With SBRT

  Up to 24 months

• Late Toxicities Associated With SBRT

  Up to 24 months

• 2-year Progression-free Survival (PFS)

  Up to 24 months

• Time to Progression (TTP)

  Up to 24 months

• Overall Survival (OS)

  Up to 24 months

Study Arms (1)

Stereotactic Body Radiotherapy

OTHER

Radiation: Stereotactic Body Radiation Therapy (SBRT)

Interventions

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)

Also known as: CyberKnife, Trilogy, True Beam, Radiosurgery, SBRT

Stereotactic Body Radiotherapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• David A. Clump, MD, PhD: lead

Study Sites (1)

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Results Point of Contact

• Title: Barbara Stadterman, MPH, MCCR, Regulatory Supervisor, CRS
• Organization: UPMC Hillman Cancer Center

stadtermanbm@upmc.edu

412-647-5554

Study Officials

• David A Clump, MD

  UPMC Hillman Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Radiation Oncology

Study Record Dates

• First Submitted: May 18, 2011
• First Posted: May 20, 2011
• Study Start: February 6, 2013
• Primary Completion: April 1, 2018
• Study Completion: June 1, 2018
• Last Updated: November 24, 2021
• Results First Posted: November 24, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)