Postoperative Proton Radiotherapy With Chemo for Pancreatic Cancer

University of Florida2 enrolled

Overview

The purpose of this study is to find out what effects, good and/or bad, proton radiation combined with chemotherapy has on resected pancreatic cancer.

Proton radiation with concomitant chemotherapy

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pancreatic Cancer

Interventions

Proton radiationRADIATION

Proton Radiation Therapy: R(0) negative ... 50.40 cobalt gray equivalent (CGE) at 1.8 CGE per fraction ; R(1) micro-positive ...54.00 CGE at 1.8 CGE per fraction; R(2) gross positive...59.40 CGE at 1.8 CGE per fraction

GemcitabineDRUG

Gemcitabine 300 mg/m2 infused over 30 minutes, weekly during proton therapy.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Histologic proof of primary head of pancreas invasive adenocarcinoma managed with a potentially curative resection * Post resection CA19-9 tumor marker baseline Exclusion Criteria: \- Previous history of invasive malignancy (except non-melanoma skin cancer and low to intermediate risk prostate cancer) unless the patient has been disease free for at least 5 years prior to study consent

Locations (2)

University of Florida Proton Therapy Institute

Jacksonville, Florida, United States

Provision Proton Therapy Center

Knoxville, Tennessee, United States

Outcomes

Primary Outcomes

Radiation Toxicity

Assessment of acute/late severe (defined as grade 3-5) radiation toxicity at the completion of therapy. Acute toxicity will be defined to be toxicity occurring within 90 days from the start of radiation treatment, and late toxicity will be defined as toxicity occurring more than 90 days from the start of radiation treatment.

Time frame: 90 days after completion of RT

Secondary Outcomes

Survival Rate

One year overall survival rate

Time frame: 1 year after completion of RT

Response rate via CA 19-9

Time frame: Every 3 months for 2 years, then every 6 months for 3-5 years then annually thereafter

Data from ClinicalTrials.gov

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