Postoperative Proton Radiotherapy With Chemo for Pancreatic Cancer (PC03)

University of Florida

Status and phase: Completed; Phase 2

Conditions: Pancreatic Cancer

Treatments: Radiation: Proton radiation; Drug: Gemcitabine

Study type: Interventional

Funder types: Other

Identifiers

NCT01553019

UFPTI 1013-PC03

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 has on resected pancreatic cancer.

Full description

Proton radiation with concomitant chemotherapy

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2 participants in 3 patient groups

1- R(0) negative

Experimental group

Description:

50.40 cobalt gray equivalent (CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine

Treatment:

Drug: Gemcitabine

Radiation: Proton radiation

2- R(1) micro-positive

Experimental group

Description:

54.00 cobalt gray equivalent(CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine

Treatment:

Drug: Gemcitabine

Radiation: Proton radiation

3- R(2) gross positive

Experimental group

Description:

59.40 cobalt gray equivalent (CGE) Proton Radiation and concomitant chemotherapy with weekly gemcitabine

Treatment:

Drug: Gemcitabine

Radiation: Proton radiation