Trial record 3 of 3 for:    16865597 [PUBMED-IDS]

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. Identifier: NCT00685763
Recruitment Status : Completed
First Posted : May 28, 2008
Results First Posted : July 3, 2014
Last Update Posted : August 24, 2017
Information provided by (Responsible Party):
University of Florida

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Pancreatic Cancer
Intervention: Radiation: Proton radiation and chemotherapy

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
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.

Proton radiation and chemotherapy: Chemotherapy Capecitabine (Xeloda ®) 1,000 mg by mouth twice a day, 5 days/week (M-F)

Proton radiation 59.4 CGE in 33 fx at 1.8 CGE per fx over 7 weeks .

Consolidation Chemotherapy: Suggested Regimen - Gemcitabine total of 12 doses

Participant Flow:   Overall Study
    Proton Radiation and Chemotherapy
Intercurrent death-incomplete treatment                1 
Protocol Violation                1 

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Unresectable Carcinoma of the Pancreas

Reporting Groups
Proton Radiation and Chemotherapy Unresectable Carcinoma of the Pancreas

Baseline Measures
   Proton Radiation and Chemotherapy 
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
Count of Participants
<=18 years      0   0.0% 
Between 18 and 65 years      3  27.3% 
>=65 years      8  72.7% 
[Units: Years]
Median (Full Range)
 (51 to 86) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
Female      6  54.5% 
Male      5  45.5% 
Region of Enrollment 
[Units: Participants]
United States   11 

  Outcome Measures

1.  Primary:   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 ]

2.  Secondary:   Collect and Analyze Tumor Control Measures   [ Time Frame: 1 year following the completion of radiation therapy ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Charles Nichols, M.D.
Organization: University of Florida Proton Therapy Institute
phone: 904-588-1800

NCCN (National Comprehensive Cancer Network) Clinical Practice Guidelines in Oncology. V.2.2006.

Responsible Party: University of Florida Identifier: NCT00685763     History of Changes
Other Study ID Numbers: UFPTI 0609-PC01
First Submitted: May 22, 2008
First Posted: May 28, 2008
Results First Submitted: May 23, 2014
Results First Posted: July 3, 2014
Last Update Posted: August 24, 2017