Clinical trial NCT00763516: Proton Radiation for Resectable Carcinoma of the Pancreas
Official title: A Pilot Study Using Neoadjuvant Proton Beam Radiation Therapy and Chemotherapy for Marginally Resectable Carcinoma of the Pancreas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreatic Cancer
Keywords: Pancreatic Cancer
Proton radiation
Chemotherapy
Xeloda
Gemzar
Resectable
Surgery
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2008-10-01
Enrollment: 8
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: The purpose of this study is to find out what effects, good and/or bad, proton radiation combined with chemotherapy and surgery has on you and your pancreatic cancer. This study will look at the side effects from the treatment and the quality of your life in relation to pain. It will also look at how the tumor responds to the combination of treatment with radiation, chemotherapy and surgery.

Detailed description: Chemotherapy capecitabine on radiation days

Proton radiation over 6 weeks

Surgery 6 weeks after radiation completion

Adjuvant Chemotherapy starting 2-8 weeks after surgery with Gemzar

Eligibility criteria: Inclusion Criteria:

* Pathologically confirmed adenocarcinoma of the pancreas.
* Patients must have marginally resectable disease.
* Patients with biliary obstruction must have adequate drainage prior to starting chemoradiation.

Exclusion Criteria:

* Evidence of distant metastasis including peritoneal seeding and/or ascites.
* Previous irradiation to the abdomen that would compromise the ability to deliver the prescribed treatment.
* Prior surgical resection.
* Gastroduodenal obstruction

Primary outcomes:
measure: Cumulative incidence of grade 3+ bowel perforation, grade 3+ bleeding and grade 4+ nonhematologic acute adverse events (occuring within 90 days of treatment start)
timeFrame: 1 year following the completion of radiation therapy
Secondary outcomes:
measure: Collect and analyze tumor control outcomes
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: Romaine C Nichols, MD
role: PRINCIPAL_INVESTIGATOR
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