Gastric Adenocarcinoma Clinical Trial
Official 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
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.
n/a
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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