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NESC: Neoadjuvant Treatment Of Gastric Adenocarcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Dr.Laurent Mineur, Institut Sainte Catherine

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Histological response rate on surgical specimen after chemotherapy and chemoradiotherapy preoperative


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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France
Institut Sainte Catherine Recruiting
Avignon, France, 84000
Contact: LAURENT MINEUR, DOCTOR    04.90.27.62.68    l.mineur@isc84.org   
Sponsors and Collaborators
Institut Sainte Catherine

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Responsible Party: Dr.Laurent Mineur, Doctor, Institut Sainte Catherine
ClinicalTrials.gov Identifier: NCT01565109    
Other Study ID Numbers: NESC
First Posted: March 28, 2012    Key Record Dates
Last Update Posted: December 21, 2012
Last Verified: December 2012
Keywords provided by Dr.Laurent Mineur, Institut Sainte Catherine:
NESC
NEOADJUVANT
GASTRIC
Additional relevant MeSH terms:
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Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action