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NESC: Neoadjuvant Treatment Of Gastric Adenocarcinoma

Primary Purpose

Gastric Adenocarcinoma

Status
Unknown status
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Docetaxel - Cisplatine - 5FU
Radiation of 45 Grays on 5 weeks
Sponsored by
Institut Sainte Catherine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Adenocarcinoma focused on measuring NESC, NEOADJUVANT, GASTRIC

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Institut Sainte CatherineRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single arm study

Arm Description

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

Outcomes

Primary Outcome Measures

Histological response rate on surgical specimen after chemotherapy and chemoradiotherapy preoperative

Secondary Outcome Measures

Full Information

First Posted
October 13, 2010
Last Updated
December 20, 2012
Sponsor
Institut Sainte Catherine
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1. Study Identification

Unique Protocol Identification Number
NCT01565109
Brief Title
NESC: Neoadjuvant Treatment Of Gastric Adenocarcinoma
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 Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2009 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut Sainte Catherine

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Adenocarcinoma
Keywords
NESC, NEOADJUVANT, GASTRIC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single arm study
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Docetaxel - Cisplatine - 5FU
Intervention Description
2 cycles of Docetaxel - Cisplatine - 5 FU
Intervention Type
Radiation
Intervention Name(s)
Radiation of 45 Grays on 5 weeks
Intervention Description
Radiochemotherapy with Oxaliplatine (J1, J15 et J29) - 5FU on 5 weeks
Primary Outcome Measure Information:
Title
Histological response rate on surgical specimen after chemotherapy and chemoradiotherapy preoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Institut Sainte Catherine
City
Avignon
ZIP/Postal Code
84000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LAURENT MINEUR, DOCTOR
Phone
04.90.27.62.68
Email
l.mineur@isc84.org

12. IPD Sharing Statement

Learn more about this trial

NESC: Neoadjuvant Treatment Of Gastric Adenocarcinoma

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