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A Trial of Chemo & Radiation Therapy for Pancreatic Cancer

2014-08-27 03:40:34 | BioPortfolio

Summary

To assess progression-free survival of patients with locally advanced pancreatic cancer who are treated with concurrent gemcitabine, 5-FU, cetuximab and external beam radiation therapy.

Description

This is an open-label, non-randomized, combination study of cetuximab, gemcitabine, 5-FU, and external beam radiotherapy in patients with locally advanced, non-metastatic pancreatic cancer.

All patients will be assessed by history and physical examination including weight, vital signs, and performance status within 14 days of initiation of therapy. Baseline hematologic and biochemical profiles, including CBC with differential, alkaline phosphatase, bilirubin, SGOT (AST), BUN, creatinine, and CA 19-9 will be completed within 14 days of initiation of therapy.

During cycle I (chemoradiation), gemcitabine (200 mg/m2) and cetuximab 400mg/m2 initial dose followed by 250mg/m2 IV weekly will be given with continuous infusion 5-FU (200 mg/m2/day) delivered 5 of every 7 days and concurrent external beam radiation therapy. Cetuximab, gemcitabine and 5-FU will begin on the first week of external beam radiotherapy and will continue throughout the course of external beam radiation therapy, and will be discontinued following the conclusion of external beam radiation therapy. All patients will have a central venous access device placed to facilitate chemotherapy administration.

During cycles 2 through 5 (chemotherapy), gemcitabine will be administered at a dose of 1000 mg/m2 over 30 minutes followed by cetuximab at a dose of 250mg/m2 over 30 minutes weekly for 3 weeks followed by one-week rest for four cycles.

Study Design

Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Pancreatic Cancer

Intervention

Gemcitabine/Fluorouracil with External Beam Radiation

Location

University of Massachusetts Medical School
Worcester
Massachusetts
United States
01655-0002

Status

Recruiting

Source

University of Massachusetts, Worcester

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:40:34-0400

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Medical and Biotech [MESH] Definitions

A deoxycytidine derivative and fluorouracil PRODRUG that is used as an ANTINEOPLASTIC ANTIMETABOLITE in the treatment of COLON CANCER; BREAST CANCER and GASTRIC CANCER.

An optical source that emits photons in a coherent beam. Light Amplification by Stimulated Emission of Radiation (LASER) is brought about using devices that transform light of varying frequencies into a single intense, nearly nondivergent beam of monochromatic radiation. Lasers operate in the infrared, visible, ultraviolet, or X-ray regions of the spectrum.

Computed tomography modalities which use a cone or pyramid-shaped beam of radiation.

The use of pre-treatment imaging modalities to position the patient, delineate the target, and align the beam of radiation to achieve optimal accuracy and reduce radiation damage to surrounding non-target tissues.

Timing the acquisition of imaging data to specific points in the breathing cycle to minimize image blurring and other motion artifacts. The images are used diagnostically and also interventionally to coordinate radiation treatment beam on/off cycles to protect healthy tissues when they move into the beam field during different times in the breathing cycle.

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