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

University of Florida

Status: Completed

Conditions: Pancreatic Cancer

Treatments: Radiation: Proton radiation and chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00685763

UFPTI 0609-PC01

Details and patient eligibility

About

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.

Full description

Chemotherapy:Capecitabine on radiation days

Proton radiation over 7 weeks

Consolidation Chemotherapy:Gemcitabine

Enrollment: 13 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Proton radiation and chemotherapy

Experimental 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.

Treatment:

Radiation: Proton radiation and chemotherapy