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Multicenter Study to Perioperative Chemotherapy for Resectable Adenocarcinoma in Gastric Cancer

NCT ID: NCT01160419

Last Updated: 2010-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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FLOT

Docetaxel, Oxaliplatin, Folinic acid, 5-FU, q 2 weeks, application of 6 cycles

Group Type OTHER

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

Intervention Type DRUG

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

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

Intervention Type DRUG

85 mg/m², 2-hour-Infusion, day 1

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

Intervention Type DRUG

200 mg/m², 1-2-hour-Infusion, day 1

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

Intervention Type DRUG

2600 mg/m², 24-hour-Infusion, day 1

Interventions

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

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

Intervention Type DRUG

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

85 mg/m², 2-hour-Infusion, day 1

Intervention Type DRUG

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

200 mg/m², 1-2-hour-Infusion, day 1

Intervention Type DRUG

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

2600 mg/m², 24-hour-Infusion, day 1

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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University of Munich - Klinikum Großhadern

Locations

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University of Munich, Klinikum Grosshadern

Munich, , Germany

Site Status

Countries

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Germany

Other Identifiers

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EudraCT Nr.: 2008-007546-56

Identifier Type: -

Identifier Source: secondary_id

NEO-FLOT

Identifier Type: -

Identifier Source: org_study_id