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

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
Sponsor:
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
Enrollment 13
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Proton Radiation and Chemotherapy
Hide Arm/Group Description

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

Period Title: Overall Study
Started 13
Completed 11
Not Completed 2
Reason Not Completed
Intercurrent death-incomplete treatment             1
Protocol Violation             1
Arm/Group Title Proton Radiation and Chemotherapy
Hide Arm/Group Description Unresectable Carcinoma of the Pancreas
Overall Number of Baseline Participants 11
Hide Baseline Analysis Population Description
Unresectable Carcinoma of the Pancreas
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  27.3%
>=65 years
8
  72.7%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 11 participants
68
(51 to 86)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants
Female
6
  54.5%
Male
5
  45.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants
11
1.Primary Outcome
Title 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)
Hide Description [Not Specified]
Time Frame 1 year following the completion of radiation therapy
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proton Radiation and Chemotherapy
Hide Arm/Group Description:

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

Overall Number of Participants Analyzed 11
Measure Type: Number
Unit of Measure: participants
0
2.Secondary Outcome
Title Collect and Analyze Tumor Control Measures
Hide Description [Not Specified]
Time Frame 1 year following the completion of radiation therapy
Outcome Measure Data Not Reported
Time Frame 1 year after completion of radiation therapy
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Proton Radiation and Chemotherapy
Hide Arm/Group Description

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

All-Cause Mortality
Proton Radiation and Chemotherapy
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Proton Radiation and Chemotherapy
Affected / at Risk (%) # Events
Total   0/11 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Proton Radiation and Chemotherapy
Affected / at Risk (%) # Events
Total   1/11 (9.09%)    
General disorders   
Fatigue  1  1/11 (9.09%)  11
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
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
Publications:
NCCN (National Comprehensive Cancer Network) Clinical Practice Guidelines in Oncology. V.2.2006.
Responsible Party: University of Florida
ClinicalTrials.gov 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