Trial Outcomes & Findings for Proton Therapy for Unresectable Cancer (CA) of Pancreas (NCT NCT00685763)

Results Overview

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

1 year following the completion of radiation therapy

Results posted on

2017-08-24

Participant milestones
Measure	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
Overall Study STARTED	13
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	2

Reasons for withdrawal
Measure	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
Overall Study Intercurrent death-incomplete treatment	1
Overall Study Protocol Violation	1

Proton Therapy for Unresectable Cancer (CA) of Pancreas

Baseline characteristics by cohort
Measure	Proton Radiation and Chemotherapy n=11 Participants Unresectable Carcinoma of the Pancreas
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Age, Continuous	68 Years n=5 Participants
Sex: Female, Male Female	6 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

Timeframe: 1 year following the completion of radiation therapy

Outcome measures
Measure	Proton Radiation and Chemotherapy n=11 Participants 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
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)	0 participants

Timeframe: 1 year following the completion of radiation therapy

Outcome data not reported

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Adverse event data not reported

Other adverse events
Measure	Proton Radiation and Chemotherapy n=11 participants at risk 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
General disorders Fatigue	9.1% 1/11 • Number of events 11 • 1 year after completion of radiation therapy

University of Florida Proton Therapy Institute

Phone: 904-588-1800