Multicenter Study to Perioperative Chemotherapy for Resectable Adenocarcinoma in Gastric Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2009 by Ludwig-Maximilians - University of Munich.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Sanofi
Information provided by:
Ludwig-Maximilians - University of Munich
ClinicalTrials.gov Identifier:
NCT01160419
First received: October 22, 2009
Last updated: October 27, 2010
Last verified: December 2009
  Purpose

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 Intervention 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 Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Ludwig-Maximilians - University of Munich:

Primary Outcome Measures:
  • Collection of the R0-Resection rate [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    after 6 cycles of biweekly FLOT chemotherapy and operation.


Estimated Enrollment: 49
Study Start Date: December 2009
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01160419

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

No publications provided

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
Study First Received: October 22, 2009
Last Updated: October 27, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Leucovorin
Folic Acid
Levoleucovorin
Oxaliplatin
Docetaxel
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antidotes
Protective Agents
Hematinics
Hematologic Agents
Therapeutic Uses
Antineoplastic Agents

ClinicalTrials.gov processed this record on July 09, 2014