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Multicenter Study to Perioperative Chemotherapy for Resectable Adenocarcinoma in Gastric Cancer

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ClinicalTrials.gov Identifier: NCT01160419
Recruitment Status : Unknown
Verified December 2009 by Ludwig-Maximilians - University of Munich.
Recruitment status was:  Active, not recruiting
First Posted : July 12, 2010
Last Update Posted : October 28, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Docetaxel 50 mg/m2, 1-hour-Infusion, day 1 Drug: Oxaliplatin 85 mg/m², 2-hour-Infusion, day 1 Drug: Folinic acid 200 mg/m², 1-2-hour-Infusion, day 1 Drug: 5-FU 2600 mg/m², 24-hour-Infusion, day 1 Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 49 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : December 2009
Estimated Primary Completion Date : May 2011
Estimated Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Collection of the R0-Resection rate [ Time Frame: 12 weeks ]
    after 6 cycles of biweekly FLOT chemotherapy and operation.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01160419


Locations
Germany
University of Munich, Klinikum Grosshadern
Munich, Germany
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
Sanofi
More Information

Responsible Party: Prof. Dr. med. V. Heinemann, University of Munich - Klinikum Großhadern
ClinicalTrials.gov Identifier: NCT01160419     History of Changes
Other Study ID Numbers: NEO-FLOT
EudraCT Nr.: 2008-007546-56
First Posted: July 12, 2010    Key Record Dates
Last Update Posted: October 28, 2010
Last Verified: December 2009

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Docetaxel
Oxaliplatin
Leucovorin
Levoleucovorin
Folic Acid
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antidotes
Protective Agents
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Hematinics