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Proton Therapy for Unresectable Cancer (CA) of Pancreas (PC01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00685763
Recruitment Status : Completed
First Posted : May 28, 2008
Results First Posted : July 3, 2014
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
University of Florida

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Radiation: Proton radiation and chemotherapy Not Applicable

Detailed Description:

Chemotherapy:Capecitabine on radiation days

Proton radiation over 7 weeks

Consolidation Chemotherapy:Gemcitabine

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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 .

Chemotherapy:

Capecitabine (Xeloda ®) 1,000 mg by mouth twice a day, 5 days/week (M-F) Consolidation Chemotherapy: Suggested Regimen - Gemcitabine total of 12 doses

Other Names:
  • Capecitabine
  • Xeloda
  • Gemcitabine
  • Gemzar


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Collect and Analyze Tumor Control Measures [ Time Frame: 1 year following the completion of radiation therapy ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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United States, Florida
University of Florida Proton Therapy Institute
Jacksonville, Florida, United States, 32206
Sponsors and Collaborators
University of Florida
Investigators
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Principal Investigator: R. Charles Nichols, MD University of Florida Proton Therapy Institute
More Information
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Publications:

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Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT00685763    
Other Study ID Numbers: UFPTI 0609-PC01
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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Florida:
Pancreatic cancer
Unresectable
Proton radiation
Chemotherapy
Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Capecitabine
 Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs