Proton Radiation for Resectable Carcinoma of the Pancreas (PC02)

University of Florida

Status: Completed

Conditions: Pancreatic Cancer

Treatments: Radiation: Proton radiation and chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00763516

UFPTI 0704-PC02

Details and patient eligibility

About

The purpose of this study is to find out what effects, good and/or bad, proton radiation combined with chemotherapy and surgery has on you and your pancreatic cancer. This study will look at the side effects from the treatment and the quality of your life in relation to pain. It will also look at how the tumor responds to the combination of treatment with radiation, chemotherapy and surgery.

Full description

Chemotherapy capecitabine on radiation days

Proton radiation over 6 weeks

Surgery 6 weeks after radiation completion

Adjuvant Chemotherapy starting 2-8 weeks after surgery with Gemzar

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pathologically confirmed adenocarcinoma of the pancreas.
• Patients must have marginally resectable disease.
• Patients with biliary obstruction must have adequate drainage prior to starting chemoradiation.

Exclusion criteria

• Evidence of distant metastasis including peritoneal seeding and/or ascites.
• Previous irradiation to the abdomen that would compromise the ability to deliver the prescribed treatment.
• Prior surgical resection.
• Gastroduodenal obstruction

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Proton radiation and chemotherapy

Experimental group

Description:

Proton radiation Capecitabine chemotherapy on radiation days Surgery Gemcitabine chemotherapy

Treatment:

Radiation: Proton radiation and chemotherapy