N/A
N=18
Neoadjuvant Stereotactic Body Radiation Therapy for Resectable Adenocarcinoma of the Pancreatic Head and/or Body
Pancreatic Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02208024 ↗Enrolled (actual)
18
Serious AEs
11.8%
Results posted
Dec 2021
Primary outcome: Primary: Number of Participants With Acute (Within 3 Months of Treatment) Grade 3 or Greater Gastrointestinal Toxicity — 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Stereotactic Body Radiation Therapy (Radiation)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- University of Cincinnati
- Primary completion
- Oct 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Acute (Within 3 Months of Treatment) Grade 3 or Greater Gastrointestinal Toxicity |
— | — |
| SECONDARY Number of Participants With Late (Greater Than 3 Months After Treatment) Grade 2 Gastritis, Enteritis, Fistula, and Ulcer or Any Other Grade 3 or Greater Gastrointestinal Toxicity |
— | — |
| SECONDARY Local Progression Free Survival |
13 | — |
| SECONDARY Metastasis Free Survival |
11 | — |
| SECONDARY Overall Survival |
14 | — |
Summary
The purpose of this study is to test the safety of focused radiation (Stereotactic Body Radiation Therapy, SBRT) on patients with pancreatic cancer that will be removed surgically.
Eligibility Criteria
Inclusion Criteria
- Age >18 years.
- Histologically confirmed pancreatic adenocarcinoma of the head and/or body; at least the majority of the histopathologic specimen must be identified as adenocarcinoma.
- Pancreatic tumors must be considered resectable at time of treatment planning. Definition of resectable: no metastases, less than 180 degree involvement of superior mesenteric vein or portal vein, no involvement of hepatic artery, superior mesenteric artery or celiac artery
- No active infection requiring hospitalization
- Adequate labs
- Life expectancy > 3 months.
- Patient is to have received chemotherapy prior to enrollment. This will typically consist of 3-4 cycles of chemotherapy. Patients will have a 2 week break between last chemotherapy administration and start of SBRT.
Exclusion Criteria
- Presence of metastatic disease.
- Infections requiring systemic antibiotic treatment.
Data sourced from ClinicalTrials.gov (NCT02208024). 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.