Clinical trial NCT00685763: Proton Therapy for Unresectable Cancer (CA) of Pancreas
Official title: A Study Using Photon/Proton Beam Radiation Therapy and Chemotherapy for Unresectable Carcinoma of the Pancreas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Keywords: Pancreatic cancer
Unresectable
Proton radiation
Chemotherapy
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2008-05-28
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out what effects, good and/or bad, proton radiation and chemotherapy has on you and your pancreatic cancer.

Detailed description: Chemotherapy:Capecitabine on radiation days

Proton radiation over 7 weeks

Consolidation Chemotherapy:Gemcitabine

Eligibility criteria: Inclusion Criteria:

Pathologically confirmed adenocarcinoma of the pancreas.

Patients must be medically inoperable or have unresectable disease

Exclusion Criteria:

* Evidence of distant metastasis; evidence of metastatic disease in the major viscera (organs), peritoneal seeding and/or ascites.
* Previous irradiation to the abdomen that would compromise the ability to deliver the prescribed treatment.
* Prior surgical resection.

Primary outcomes:
measure: Cumulative Incidence of grade3+ Bowel Perforation, Grade 3+ Bleeding (Ocurring Withing 1 Years) and grade4+ Nonhematologic Acute Adverse Events (Limited to Within 90 Days of Treatment Start)
timeFrame: 1 year following the completion of radiation therapy
Secondary outcomes:
measure: Collect and Analyze Tumor Control Measures
timeFrame: 1 year following the completion of radiation therapy
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: University of Florida Proton Therapy Institute
state: Florida
Study officials:
affiliation: University of Florida Proton Therapy Institute
name: R. Charles Nichols, MD
role: PRINCIPAL_INVESTIGATOR
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