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Phase II Multicenter Study in the Preoperative Treatment of Gastric Adenocarcinoma Consisting of Chemotherapy Using Docetaxel-cisplatin-5FU + Lenograstim Followed by Chemoradiation Based 5FU and Oxaliplatin


Phase 2
18 Years
65 Years
Open (Enrolling)
Both
Gastric Adenocarcinoma

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Trial Information

Phase II Multicenter Study in the Preoperative Treatment of Gastric Adenocarcinoma Consisting of Chemotherapy Using Docetaxel-cisplatin-5FU + Lenograstim Followed by Chemoradiation Based 5FU and Oxaliplatin


Inclusion Criteria:



- Male or female patients, Age: 18 to 65

- ECOG performance status of ≤ 1

- Histological documentation of the gastric adenocarcinoma. An extension will be
admitted to the omentum

- Adenocarcinoma of the stomach according to staging classification TNM Scannographic:
T2bN0, T2bN1, T3NO T3N +, T4N0, and T4N + M0 (cardia, Siewert II, III, fundus, body,
antrum) performed by ultrasonography and CT Scan. Optional : laparoscopy

- A positive peritoneal cytology is not a disqualifying factor if there is no
macroscopic carcinomatosis

- Absence of previous abdominal irradiation above the 5th sacral vertebra (in the
liver, pancreas, spleen, or mediastinal lodge)

- Loss of weight less than 15% over the base weight before diagnosis

- No psychological, familial, sociological or geographical condition that may affect
compliance and adherence to treatment, patient monitoring or understanding of the
study.

- Signed informed consent obtained before any study specific procedures.

- Food Consumption> 1000 calories / day whatever the mode of administration (enteral or
parenteral)

- Laboratory test conducted within one week of starting to study treatment:

- Absolute neutrophil count > 1500/mm3

- Platelet count > 100 000/mm3

- Total bilirubin <2 mg/dL

- Serum creatinine <13 mg/dL or creatinine clearance > 40 ml/min

- Hemoglobin (Hgb) ≥ 10 g/dL (Hemoglobin transfusion if necessary)

- ALT / AST <1.5 x ULN

- PTT ≥ 60 %

- Life expectancy of at least 3 months

Exclusion Criteria:

- Peripheral sensory neuropathy ≥ grade 1 (according to CTCAE version 3.0).

- Myocardial infarction, stroke or pulmonary embolism, unstable angina less than 6
months before start of study drug.

- Uncontrolled infection

- Pregnant or breast-feeding patients. Women of childbearing potential must have a
pregnancy test performed.

- Prior treatment for gastric adenocarcinoma

- Lower limbs arteritis (≥ stage II according the Leriche and Fontain classification)

- Patient participating in another clinical trial or already receiving other
anti-cancer treatment

- Concomitant treatment with a phenytoin

- Known previous / current malignancy within the last 5 years except for non-melanoma
skin, non-metastatic prostate carcinoma and cervival carcinoma in situ or superficial
bladder carcinoma.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Histological response rate on surgical specimen after chemotherapy and chemoradiotherapy preoperative

Outcome Time Frame:

.....

Safety Issue:

No

Authority:

France : Agence Française de Sécurité Sanitaire de Produits de santé

Study ID:

NESC

NCT ID:

NCT01565109

Start Date:

March 2009

Completion Date:

March 2018

Related Keywords:

  • Gastric Adenocarcinoma
  • NESC
  • NEOADJUVANT
  • GASTRIC
  • Adenocarcinoma
  • Adenocarcinoma, Mucinous
  • Stomach Neoplasms

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