Proton Radiation for Resectable Carcinoma of the Pancreas
NCT ID: NCT00763516
Last Updated: 2017-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
8 participants
INTERVENTIONAL
2009-02-28
2017-08-17
Brief Summary
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Detailed Description
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Proton radiation over 6 weeks
Surgery 6 weeks after radiation completion
Adjuvant Chemotherapy starting 2-8 weeks after surgery with Gemzar
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Proton radiation and chemotherapy
Proton radiation
Capecitabine chemotherapy on radiation days
Surgery
Gemcitabine chemotherapy
Proton radiation and chemotherapy
Neoadjuvant Chemotherapy Capecitabine (Xeloda®) 1,000 mg by mouth twice a day 5 days/week (M-F) on radiation days only
Proton radiation 50.4 cobalt gray equivalent(CGE) in 28 fractions over 6 weeks
Surgery: Gross total resection of primary tumor and regional lymph nodes done 6 weeks after completion of radiation
Adjuvant Chemotherapy starting 2-8 weeks after surgery Suggested Regimen: Gemcitabine (Gemzar®) 1,000 mg/m2 IV total of 18 doses
Interventions
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Proton radiation and chemotherapy
Neoadjuvant Chemotherapy Capecitabine (Xeloda®) 1,000 mg by mouth twice a day 5 days/week (M-F) on radiation days only
Proton radiation 50.4 cobalt gray equivalent(CGE) in 28 fractions over 6 weeks
Surgery: Gross total resection of primary tumor and regional lymph nodes done 6 weeks after completion of radiation
Adjuvant Chemotherapy starting 2-8 weeks after surgery Suggested Regimen: Gemcitabine (Gemzar®) 1,000 mg/m2 IV total of 18 doses
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients must have marginally resectable disease.
* Patients with biliary obstruction must have adequate drainage prior to starting chemoradiation.
Exclusion Criteria
* Previous irradiation to the abdomen that would compromise the ability to deliver the prescribed treatment.
* Prior surgical resection.
* Gastroduodenal obstruction
18 Years
ALL
No
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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Romaine C Nichols, MD
Role: PRINCIPAL_INVESTIGATOR
University of Florida Proton Therapy Institute
Locations
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University of Florida Proton Therapy Institute
Jacksonville, Florida, United States
Countries
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References
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Other Identifiers
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UFPTI 0704-PC02
Identifier Type: -
Identifier Source: org_study_id
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