NESC: Neoadjuvant Treatment Of Gastric Adenocarcinoma
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|ClinicalTrials.gov Identifier: NCT01565109|
Recruitment Status : Unknown
Verified December 2012 by Dr.Laurent Mineur, Institut Sainte Catherine.
Recruitment status was: Recruiting
First Posted : March 28, 2012
Last Update Posted : December 21, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastric Adenocarcinoma||Drug: Docetaxel - Cisplatine - 5FU Radiation: Radiation of 45 Grays on 5 weeks||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2009|
|Estimated Primary Completion Date :||March 2013|
|Estimated Study Completion Date :||March 2018|
Experimental: Single arm study
Docetaxel - Cisplatine - 5FU 2 cycles of Docetaxel - Cisplatine - 5 FU
Radiation: Radiation of 45 Grays on 5 weeks Radiochemotherapy with Oxaliplatine (J1, J15 et J29) - 5FU on 5 weeks
Drug: Docetaxel - Cisplatine - 5FU
2 cycles of Docetaxel - Cisplatine - 5 FU
Radiation: Radiation of 45 Grays on 5 weeks
Radiochemotherapy with Oxaliplatine (J1, J15 et J29) - 5FU on 5 weeks
- Histological response rate on surgical specimen after chemotherapy and chemoradiotherapy preoperative
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01565109
|Institut Sainte Catherine||Recruiting|
|Avignon, France, 84000|
|Contact: LAURENT MINEUR, DOCTOR 04.90.27.62.68 firstname.lastname@example.org|