Docetaxel in Locally Advanced Gastric Adenocarcinoma
NEOTAX
Docetaxel, Cisplatin and Fluorouracil Combination in the Neoadjuvant Treatment of Locally Advanced Gastric Adenocarcinoma : Phase II Clinical Study
1 other identifier
interventional
59
1 country
1
Brief Summary
Study objectives: To determine Ro resection rate of Docetaxel, cisplatin and fluorouracil combination for the treatment of neoadjuvant gastric carcinoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2006
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedFirst Submitted
Initial submission to the registry
June 21, 2006
CompletedFirst Posted
Study publicly available on registry
June 22, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2012
CompletedNovember 4, 2014
November 1, 2014
5.8 years
June 21, 2006
November 3, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the R0 resection rate for the treatment of locally advanced gastric carcinoma with Docetaxel, Cisplatin, Fluorouracil combination.
3 cycles
Study Arms (1)
Docetaxel/Cisplatin/Fluorouracil (DCF)
EXPERIMENTALDCF 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
Interventions
Formulation: infusion solution Route of administration: IV infusion on the first day of each 21-day cycle Dose regimen: 75 mg/m2
Formulation: infusion solution Route of administration: IV infusion on the first day of each 21-day cycle Dose regimen: 75 mg/m2
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
Eligibility Criteria
You may qualify if:
- 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
- +1 more criteria
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (1)
Sanofi-Aventis Administrative Office
Istanbul, Turkey (Türkiye)
Related Publications (1)
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.
PMID: 25234436RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Edibe Taylan
Sanofi
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2006
First Posted
June 22, 2006
Study Start
June 1, 2006
Primary Completion
March 1, 2012
Study Completion
March 1, 2012
Last Updated
November 4, 2014
Record last verified: 2014-11