Proton Therapy for Unresectable Cancer (CA) of Pancreas (PC01)
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|ClinicalTrials.gov Identifier: NCT00685763|
Recruitment Status : Completed
First Posted : May 28, 2008
Results First Posted : July 3, 2014
Last Update Posted : August 24, 2017
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|Condition or disease||Intervention/treatment||Phase|
|Pancreatic Cancer||Radiation: Proton radiation and chemotherapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||13 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Study Using Photon/Proton Beam Radiation Therapy and Chemotherapy for Unresectable Carcinoma of the Pancreas|
|Study Start Date :||March 2008|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||June 29, 2017|
Experimental: Proton radiation and chemotherapy
Chemotherapy and Radiation Combination
Proton radiation 59.4 cobalt gray equivalent(CGE) in 33 fx at 1.8 CGE per fx over 7 weeks.
Capecitabine (Xeloda ®) 1,000 mg by mouth approximately every 12 hrs, 5 days/week starting the first day of radiation until the end of radiation, but on radiation days only.
Consolidation Chemotherapy starting 4 weeks after the completion of radiation
Gemcitabine (Gemzar ®) Suggested Regimen - 1,000mg/m2 by IV over 30 minutes once a week for 3 weeks (followed by a week of rest) for 12 total doses.
Radiation: Proton radiation and chemotherapy
Proton radiation 59.4 CGE in 33 fx at 1.8 CGE per fx over 7 weeks .
Capecitabine (Xeloda ®) 1,000 mg by mouth twice a day, 5 days/week (M-F) Consolidation Chemotherapy: Suggested Regimen - Gemcitabine total of 12 doses
- 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) [ Time Frame: 1 year following the completion of radiation therapy ]
- Collect and Analyze Tumor Control Measures [ Time Frame: 1 year following the completion of radiation therapy ]
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|Ages Eligible for Study:||18 Years to 100 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
Pathologically confirmed adenocarcinoma of the pancreas.
Patients must be medically inoperable or have unresectable disease
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00685763
|United States, Florida|
|University of Florida Proton Therapy Institute|
|Jacksonville, Florida, United States, 32206|
|Principal Investigator:||R. Charles Nichols, MD||University of Florida Proton Therapy Institute|
|Responsible Party:||University of Florida|
|Other Study ID Numbers:||
|First Posted:||May 28, 2008 Key Record Dates|
|Results First Posted:||July 3, 2014|
|Last Update Posted:||August 24, 2017|
|Last Verified:||July 2017|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Endocrine System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs