Multicenter Study to Perioperative Chemotherapy for Resectable Adenocarcinoma in Gastric Cancer

October 27, 2010 updated by: Ludwig-Maximilians - University of Munich

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

49

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Munich, Germany
        • University of Munich, Klinikum Grosshadern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histologically Confirmed Adenocarcinoma of the Gastroesophageal Junction (AEG I-III) or Gastric Adenocarcinoma (every T, N+ or T3/T4, Nx, M0)
  • Written Informed Consent
  • Age ≥ 18 Years
  • Expected operability
  • ECOG ≤ 2
  • Exclusion of Peritoneal Metastasis
  • Adequate Hematological, Renal, Cardiac and Hepatic Function
  • Effective Contraception

Exclusion Criteria:

  • Prior Chemotherapy or Radiotherapy of the Adenocarcinoma of the Gastroesophageal Junction (AEG I-III) or Gastric Adenocarcinoma
  • Not Histologically Confirmed Primary Tumor
  • Distant Metastasis, Local Relapse
  • Known Hypersensitivity for 5-Fluorouracil, Leucovorin, Oxaliplatin or Docetaxel
  • Known Dihydropyrimidin-Dehydrogenase (DPD) - Deficiency
  • Peripheral Polyneuropathy ≥ Grade II (NCI-CTCAE, Version 3.0)
  • Myocardial Infarction in the last 3 Months, Cardiac Insufficiency Grade II-IV (NYHA)
  • Severe Comorbidity or Acute Infections
  • Pregnancy or Breast Feeding
  • Insufficient Contraception
  • Participation in another Clinical Trial (Simultaneously or 30 Days Prior to Enrollment)
  • Malignancy <5 years (except: Carcinoma In Situ of the Cervix Uteri or Adequately Treated Basalioma of the Skin)
  • Lack of Legal Capacity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: FLOT
Docetaxel, Oxaliplatin, Folinic acid, 5-FU, q 2 weeks, application of 6 cycles
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collection of the R0-Resection rate
Time Frame: 12 weeks
after 6 cycles of biweekly FLOT chemotherapy and operation.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (ANTICIPATED)

May 1, 2011

Study Completion (ANTICIPATED)

May 1, 2014

Study Registration Dates

First Submitted

October 22, 2009

First Submitted That Met QC Criteria

July 9, 2010

First Posted (ESTIMATE)

July 12, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 28, 2010

Last Update Submitted That Met QC Criteria

October 27, 2010

Last Verified

December 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEO-FLOT
  • EudraCT Nr.: 2008-007546-56

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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