NESC: Neoadjuvant Treatment of Gastric Adenocarcinoma

It is estimated to 7300 the number of new cases of gastric cancer each year in France.

According to a randomized trial comparing 3 cycles of ECF (epirubicin, cisplatin, 5FU) administered before surgery and 3 cycles after surgery with surgery alone in adenocarcinoma of the stomach and lower esophagus, clinical and experimental data are the neoadjuvant chemotherapy is a new standard treatment for operable gastric cancer. This treatment with a median survival of more than 3 years to obtain a hazard ratio of 0.75 in favor of chemotherapy arm (p = 0.009). The 5-year survival being 36% for patients treated with chemotherapy versus 23% for surgery alone. Progression-free survival was also significantly prolonged with a hazard ratio of 0.66.

The proposed clinical study by Ajani et al shows that the combination of Docetaxel with the schema Cisplatin - 5FU provides greater clinical benefit and induces to consider the triple combination as a reference treatment in metastatic gastric cancer in patients under 65 years.

Preoperative radiochemotherapy is expected to increase the rate of curative resections, reduce gastrointestinal and hematologic toxicity.

Two studies evaluating the feasibility of preoperative RTCT in operable gastric adenocarcinoma with continuous 5GU (+ or - paclitaxel) and 45 Gy are available and the combination 5FU oxaliplatin has been assessed in the esophagus and rectum tumors.

The NESC study, Phase II, proposes the following schema: 2 cycles of chemotherapy with Docetaxel - Cisplatin - 5FU then preoperative chemoradiation with oxaliplatin - continuous 5FU and radiotherapy in locally advanced gastric adenocarcinoma stage III and IV non-metastatic administered before surgery.

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Key information

Conditions

Gastric Adenocarcinoma

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institut Sainte Catherine

Avignon, 84000, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Docetaxel - Cisplatine - 5FU

Drug

2 cycles of Docetaxel - Cisplatine - 5 FU

Radiation of 45 Grays on 5 weeks

Radiation

Radiochemotherapy with Oxaliplatine (J1, J15 et J29) - 5FU on 5 weeks

Primary outcomes

Histological response rate on surgical specimen after chemotherapy and chemoradiotherapy preoperative

Time frame: 1year

Histological response rate

Sponsors and collaborators

Lead sponsor

Recherche clinique

Other

Registry information

Official study title

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

Important dates

Study start: 2009
Primary completion: 2016
Study completion: 2018
First posted: Mar 28, 2012
Registry last updated: Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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