N/A
N=50
SBRT for Close or Positive Margins After Resection of Pancreatic Adenocarcinoma
Adenocarcinoma of the Pancreas
Bottom Line
View on ClinicalTrials.gov: NCT01357525 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Nov 2021
Primary outcome: Primary: Local Progression-free Survival (LPFS) at 1-year — 85 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stereotactic Body Radiation Therapy (SBRT) (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- David A. Clump, MD, PhD
- Primary completion
- Apr 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Local Progression-free Survival (LPFS) at 1-year |
85 | — |
| PRIMARY Local Progression-free Survival (LPFS) at 2-years |
78.12 | — |
| PRIMARY Local Progression-free Survival (LPFS) |
NA | — |
| PRIMARY Regional Progression-free Survival (RPFS) |
NA | — |
| PRIMARY Regional Progression-free Survival (RPFS) at 2-years |
72.2 | — |
| PRIMARY Distant Metastasis-free Survival (DMFS) at 2 Years |
49.69 | — |
| PRIMARY Distant Metastasis-free Survival (DMFS) |
21 | — |
| SECONDARY Acute Toxicities Associated With SBRT |
4.1 | — |
| SECONDARY Late Toxicities Associated With SBRT |
— | — |
| SECONDARY 2-year Progression-free Survival (PFS) |
32.79 | — |
| SECONDARY Time to Progression (TTP) |
12 | — |
| SECONDARY Overall Survival (OS) |
18 | — |
| SECONDARY Overall Survival (OS) at 1-year |
68 | — |
| SECONDARY Overall Survival (OS) at 2-years |
39.95 | — |
| SECONDARY Quality of Life (QoL) FACT-G |
24; 25; 24; 23; 18; 26 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Histologically or cytologically proven adenocarcinoma of the pancreas that has been resected with a close ( 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.
Data sourced from ClinicalTrials.gov (NCT01357525). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.