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Docetaxel in Locally Advanced Gastric Adenocarcinoma (NEOTAX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00343239
Recruitment Status : Completed
First Posted : June 22, 2006
Last Update Posted : November 4, 2014
Information provided by (Responsible Party):

Brief Summary:

Study objectives:

To determine Ro resection rate of Docetaxel, cisplatin and fluorouracil combination for the treatment of neoadjuvant gastric carcinoma.

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Drug: Docetaxel Drug: Cisplatin Drug: Fluorouracil Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 59 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Docetaxel, Cisplatin and Fluorouracil Combination in the Neoadjuvant Treatment of Locally Advanced Gastric Adenocarcinoma : Phase II Clinical Study
Study Start Date : June 2006
Primary Completion Date : March 2012
Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

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

Arm Intervention/treatment
Experimental: Docetaxel/Cisplatin/Fluorouracil (DCF)
DCF combination for three 21-day cycles unless a disease progression is observed at the tumor assessment scheduled after the second cycle or due to patient intolerability
Drug: Docetaxel

Formulation: infusion solution

Route of administration: IV infusion on the first day of each 21-day cycle

Dose regimen: 75 mg/m2

Drug: Cisplatin

Formulation: infusion solution

Route of administration: IV infusion on the first day of each 21-day cycle

Dose regimen: 75 mg/m2

Drug: Fluorouracil

Formulation: infusion solution

Route of administration: IV infusion on the first day of each 21-day cycle

Dose regimen: 750 mg/m2/day for 5 days

Primary Outcome Measures :
  1. To determine the R0 resection rate for the treatment of locally advanced gastric carcinoma with Docetaxel, Cisplatin, Fluorouracil combination. [ Time Frame: 3 cycles ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically proven gastric adenocarcinoma diagnosis
  • Selected Stage IIB (T3N0M0), Stage IIIA (T2aN2M0, T2bN2M0, T3N1M0, T4N0M0), Stage IIIB (T3N2M0) and selected Stage IV (all T4 , NM0, all TN3M0's). Clinical staging performed with endoscopic ultrasound and CT. Laparotomy or laparoscopy is preferred to determine resectability and peritoneal involvement.
  • ECOG performance status between 0 and 2
  • Acceptable hematological profile :

    • WBC (White Blood Cell) count ≥4000/mm3
    • Platelet count ≥100 000 mm3
    • Hemoglobin ≥9 g/100 mL (if lower, may be included following transfusion)
  • Adequate renal function

    • Serum creatinine <1.2 mg/dl or calculated creatinine clearance in 24-hours urine >60 mL/min.
  • Adequate hepatic function

    • Bilirubin < UNL
    • Transaminases (ALT, AST) <2.5 x UNL
    • Alcaline phosphatase <2.5 x UNL
  • Adequate pulmonary function
  • Adequate cardiac function
  • No prior chemotherapy for gastric cancer

Exclusion Criteria:

  • Other histological types of gastric cancer (leiomyosarcoma, lymphoma) than adenocarcinoma
  • Pregnant or lactating patients
  • Patients with brain, bone or other metastases; peritoneal involvement
  • Other serious underlying medical conditions which could impair the ability of the patient to participate in the study (congestive heart failure, serious arrhythmia, uncontrolled diabetes mellitus, serious neuropathy), history of myocardial infarction within 6 months prior to study entry
  • Previous or other current malignancies, with the exception of carcinoma of the cervix uteri or breast cancer or basal cell skin cancer and a disease-free period shorter than 5 years
  • Active infection and other serious disease
  • Any other experimental drugs within a 4-week period prior to the study
  • Contraindications for the use of any study drug (e.g. history of hypersensitivity to the contents of the study drugs)

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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): NCT00343239

Sanofi-Aventis Administrative Office
Istanbul, Turkey
Sponsors and Collaborators
Study Director: Edibe Taylan Sanofi

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00343239     History of Changes
Other Study ID Numbers: DOCET_L_00072
First Posted: June 22, 2006    Key Record Dates
Last Update Posted: November 4, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Stomach Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs