NESC: Neoadjuvant Treatment Of Gastric Adenocarcinoma

December 20, 2012 updated by: Dr.Laurent Mineur, Institut Sainte Catherine

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Avignon, France, 84000
        • Recruiting
        • Institut Sainte Catherine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Histological response rate on surgical specimen after chemotherapy and chemoradiotherapy preoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Sainte Catherine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

March 1, 2018

Study Registration Dates

First Submitted

October 13, 2010

First Submitted That Met QC Criteria

March 26, 2012

First Posted (Estimate)

March 28, 2012

Study Record Updates

Last Update Posted (Estimate)

December 21, 2012

Last Update Submitted That Met QC Criteria

December 20, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NESC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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