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Docetaxel, Cisplatin and Fluorouracil Combination in the Neoadjuvant Treatment of Locally Advanced Gastric Adenocarcinoma : Phase II Clinical Study

Phase 2
18 Years
70 Years
Not Enrolling
Stomach Neoplasms

Thank you

Trial Information

Docetaxel, Cisplatin and Fluorouracil Combination in the Neoadjuvant Treatment of Locally Advanced Gastric Adenocarcinoma : Phase II Clinical Study

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

- 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.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine the Ro resection rate for the treatment of locally advanced gastric carcinoma with Docetaxel, Cisplatin, Fluorouracil combination.

Outcome Time Frame:

Follow-up time

Safety Issue:


Principal Investigator

Edibe Taylan

Investigator Role:

Study Director

Investigator Affiliation:



Turkey: Ministry of Health

Study ID:




Start Date:

June 2006

Completion Date:

March 2012

Related Keywords:

  • Stomach Neoplasms
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Neoplasms
  • Stomach Neoplasms