Pilot Study To Evaluate Stereotactic Body Radiation Therapy For Palliative Management Of Unresectable, Locally Recurrent Pancreatic Or Periampullary Adenocarcinoma
No standard treatment option has yet been established for patients who develop locally
progressive disease after definitive treatment of pancreatic cancer or periampullary cancers
(duodenal, ampullary, bile duct) with standard of care or protocol combined modality
therapy. Stereotactic body radiation therapy (SBRT) administered in 1-3 fractions has been
shown to be an effective treatment option for patients with unresectable, locally advanced
pancreatic adenocarcinoma, achieving local control rates of 84-92% at one year. Associated
late gastrointestinal toxicity rates have been reported to be 22-25% at 1 year. The
investigators hypothesize that similarly excellent local control rates (80-90% at one year)
with a reasonable rate of toxicity (≤ 20%) can be achieved using SBRT delivered as 5 Gy x 5
for patients with local failure after previous treatment with conventional chemoradiation
therapy (CRT) with or without surgery and as 6.6 Gy x 5 for radiation-naïve patients with
local failure after previous treatment with surgery and/or chemotherapy. The toxicities of
note for this trial are grade 2 and greater gastritis, fistula, enteritis, or ulcer and any
grade 3-4 GI toxicity.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
GI toxicity
Grade 2 or greater late gastritis, fistula, enteritis, ulcer, or late grade 3-4 gastrointestinal toxicity at one year
1 year from treatment start
Yes
Joseph Herman, M.D.
Principal Investigator
Johns Hopkins University
United States: Food and Drug Administration
J1273
NCT01781728
January 2013
Name | Location |
---|---|
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231 |