Clinical trial NCT00343239: Docetaxel in Locally Advanced Gastric Adenocarcinoma
Official title: Docetaxel, Cisplatin and Fluorouracil Combination in the Neoadjuvant Treatment of Locally Advanced Gastric Adenocarcinoma : Phase II Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stomach Neoplasms
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-06-22
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Study objectives:

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


Eligibility criteria: 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.

Primary outcomes:
measure: To determine the R0 resection rate for the treatment of locally advanced gastric carcinoma with Docetaxel, Cisplatin, Fluorouracil combination.
timeFrame: 3 cycles
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Edibe Taylan
role: STUDY_DIRECTOR
References:
citation: Ozdemir N, Abali H, Vural M, Yalcin S, Oksuzoglu B, Civelek B, Oguz D, Bostanci B, Yalcin B, Zengin N. Docetaxel, cisplatin, and fluorouracil combination in neoadjuvant setting in the treatment of locally advanced gastric adenocarcinoma: Phase II NEOTAX study. Cancer Chemother Pharmacol. 2014 Dec;74(6):1139-47. doi: 10.1007/s00280-014-2586-6. Epub 2014 Sep 19.