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Proton Therapy for Unresectable Cancer (CA) of Pancreas

A Study Using Photon/Proton Beam Radiation Therapy and Chemotherapy for Unresectable Carcinoma of the Pancreas

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00685763
Acronym
PC01
Enrollment
13
Registered
2008-05-28
Start date
2008-03-31
Completion date
2017-06-29
Last updated
2017-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Cancer

Keywords

Pancreatic cancer, Unresectable, Proton radiation, Chemotherapy

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.

Detailed description

Chemotherapy:Capecitabine on radiation days Proton radiation over 7 weeks Consolidation Chemotherapy:Gemcitabine

Interventions

RADIATIONProton 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

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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)1 year following the completion of radiation therapy

Secondary

MeasureTime frame
Collect and Analyze Tumor Control Measures1 year following the completion of radiation therapy

Countries

United States

Participant flow

Participants by arm

ArmCount
Proton Radiation and Chemotherapy
Unresectable Carcinoma of the Pancreas
11
Total11

Withdrawals & dropouts

PeriodReasonFG000
Overall StudyIntercurrent death-incomplete treatment1
Overall StudyProtocol Violation1

Baseline characteristics

CharacteristicProton Radiation and Chemotherapy
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
8 Participants
Age, Categorical
Between 18 and 65 years
3 Participants
Age, Continuous68 Years
Region of Enrollment
United States
11 participants
Sex: Female, Male
Female
6 Participants
Sex: Female, Male
Male
5 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
1 / 11
serious
Total, serious adverse events
0 / 11

Outcome results

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

ArmMeasureValue (NUMBER)
Proton Radiation and ChemotherapyCumulative 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
Secondary

Collect and Analyze Tumor Control Measures

Time frame: 1 year following the completion of radiation therapy

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026