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Multicenter Study to Perioperative Chemotherapy for Resectable Adenocarcinoma in Gastric Cancer

2014-08-27 03:12:17 | BioPortfolio

Summary

The rationale of the NEO-FLOT-trial consists of an intensification of the neoadjuvant treatment.

This strategy is based upon the clear advantage of perioperative treatment and the fact, that in former trials adjuvant treatment could only be given in half of the patients (Cunningham 2006, Boige 2007).

In this study neoadjuvant chemotherapy is applied during a period of 12 weeks with an interim staging after 6 weeks.Due to the favourable efficacy and toxicity data the FLOT-regimen was chosen for the neoadjuvant treatment consisting of oxaliplatin, docetaxel, folinic acid and 5-Fluorouracil (Al-Batran 2008).

Postoperative treatment according to the results of the MAGIC trail is not part of the trail and is given at the responsibility of the participating centres.

Study Design

Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Gastric Cancer

Intervention

Docetaxel 50 mg/m2, 1-hour-Infusion, day 1, Oxaliplatin 85 mg/m², 2-hour-Infusion, day 1, Folinic acid 200 mg/m², 1-2-hour-Infusion, day 1, 5-FU 2600 mg/m², 24-hour-Infusion, day 1

Location

University of Munich, Klinikum Grosshadern
Munich
Germany

Status

Recruiting

Source

Ludwig-Maximilians - University of Munich

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:17-0400

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Medical and Biotech [MESH] Definitions

Use of any infusion therapy on an ambulatory, outpatient, or other non-institutionalized basis.

The maximum exposure to a biologically active physical or chemical agent that is allowed during an 8-hour period (a workday) in a population of workers, or during a 24-hour period in the general population, which does not appear to cause appreciable harm, whether immediate or delayed for any period, in the target population. (From Lewis Dictionary of Toxicology, 1st ed)

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A secure online website that provides patients convenient 24-hour access to personal health information via an Internet connection.

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