Status:
UNKNOWN
Multicenter Study to Perioperative Chemotherapy for Resectable Adenocarcinoma in Gastric Cancer
Lead Sponsor:
Ludwig-Maximilians - University of Munich
Collaborating Sponsors:
Sanofi
Conditions:
Gastric Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 forme...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2014
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT01160419
Start Date
December 1 2009
End Date
May 1 2014
Last Update
October 28 2010
Active Locations (1)
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1
University of Munich, Klinikum Grosshadern
Munich, Germany