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Multicenter Study to Perioperative Chemotherapy for Resectable Adenocarcinoma in Gastric Cancer

NCT01160419 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2010-10-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Docetaxel 50 mg/m2, 1-hour-Infusion, day 1

50 mg/m2, 1-hour-Infusion, day 1

DRUG

Oxaliplatin 85 mg/m², 2-hour-Infusion, day 1

85 mg/m², 2-hour-Infusion, day 1

DRUG

Folinic acid 200 mg/m², 1-2-hour-Infusion, day 1

200 mg/m², 1-2-hour-Infusion, day 1

DRUG

5-FU 2600 mg/m², 24-hour-Infusion, day 1

2600 mg/m², 24-hour-Infusion, day 1

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY

  • Ludwig-Maximilians - University of Munich

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-12-31
Primary Completion
2011-05-31
Completion
2014-05-31

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01160419 on ClinicalTrials.gov