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Pilot Study To Evaluate Stereotactic Body Radiation Therapy For Palliative Management Of Unresectable, Locally Recurrent Pancreatic Or Periampullary Adenocarcinoma


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Pancreatic Cancer, Pancreatic Adenocarcinoma, Periampullary Cancer, Periampullary Adenocarcinoma

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Trial Information

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.


Inclusion Criteria:



- 18 years of age or older

- Karnofsky Performance Status greater than 70%

- confirmed adenocarcinoma of the pancreas

- pancreatic pr periampullary tumor less than 8.0 cm in greatest axial dimension

- Either:

- standard of care treatment for pancreatic cancer that included radiation therapy
or

- standard of care treatment for pancreatic cancer that did not include radiation
therapy

- disease progression

- normal blood values

- ability to understand and give consent

- life expectancy of greater than 3 months

Exclusion Criteria:

- extensive metastatic disease

- performance status of less than 70

- children are excluded form the study

- no uncontrolled intercurrent illness

- no concurrent malignancy other than melanoma

- pregnant or breast feeding women are excluded

- women who are not post-menopausal and have a positive pregnancy test

- life expectancy of less than 3 months

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Outcome Measure:

GI toxicity

Outcome Description:

Grade 2 or greater late gastritis, fistula, enteritis, ulcer, or late grade 3-4 gastrointestinal toxicity at one year

Outcome Time Frame:

1 year from treatment start

Safety Issue:

Yes

Principal Investigator

Joseph Herman, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Johns Hopkins University

Authority:

United States: Food and Drug Administration

Study ID:

J1273

NCT ID:

NCT01781728

Start Date:

January 2013

Completion Date:

Related Keywords:

  • Pancreatic Cancer
  • Pancreatic Adenocarcinoma
  • Periampullary Cancer
  • Periampullary Adenocarcinoma
  • recurrent
  • unresectable
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Pancreatic Neoplasms

Name

Location

The Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231