Clinical trial NCT01342354: Study of Stereotactic Body Radiation Therapy in Patients With Intact Pancreatic Cancer
Official title: A Study of Stereotactic Body Radiation Therapy in Patients With Unresected Carcinoma of the Pancreas or Ampulla
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Pancreatic Cancer
Keywords: Pancreatic Cancer
Stereotactic Radiation
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2011-04-27
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This purpose of this study is to determine the highest tolerated dose of Stereotactic Body Radiation Therapy (SBRT) and also to determine the appropriate dose for intact pancreatic cancer.


Eligibility criteria: Inclusion Criteria:

* Patients must have histologically confirmed, unresected cancer of the pancreas or ampulla. The cancer may include any invasive histology (e.g. adenocarcinoma, neuroendocrine carcinoma).
* Patients must have measurable radiographic disease.Patients with previous complete resection are only eligible if there is measurable radiographic disease which is clearly felt to represent locally recurrent disease.
* Patients may receive any number of cycles of chemotherapy prior to treatment with SBRT, but not within 2 weeks of the first fraction of RT.
* Age \> or = 18 years.
* Eastern Cooperative Oncology Group (ECOG) performance status \< or = 2 (Karnofsky \> or = 60%)
* Life expectancy of greater than 3 months.
* Patients must have normal organ and marrow function.
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Concurrent investigational therapy delivered over the period of treatment or observation (28 days post-RT) for dose limiting toxicity.
* Prior radiation therapy to the abdominal area which would overlap with the proposed area of treatment.
* Pregnancy.
* Primary disease \> 7.5 cm in largest diameter as measured by CT or MRI.
* Gross extension of tumor into the lumen of the duodenum.
* Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Use of bevacizumab or vascular endothelial growth factor inhibitor chemotherapy within 3 months before RT or 6 months after RT.

Primary outcomes:
measure: Maximum Tolerated Dose (phase 1)
timeFrame: 28 days
measure: Identify the appropriate dose for treatment of unresected carcinoma of the ampulla or pancreas
timeFrame: 28 days
Secondary outcomes:
measure: Reported side effects
timeFrame: 12 months after treatment
measure: Change in patient reported pain score using visual analog scale
timeFrame: 12 months after treatment
measure: Number of patients eligible for surgery to remove tumor after treatment
timeFrame: 12 months after treatment
measure: Number of patients with disease control
timeFrame: 12 months after treatment
measure: Change in patient reported outcomes using FACT-Hepatobiliary (FACT-Hep) quality of life questionnaire.
timeFrame: 12 months after treatment
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
affiliation: University of Chicago
name: Stanley Liauw, MD
role: PRINCIPAL_INVESTIGATOR
References: