Phase II Study of Neoadjuvant Taxotere, Cisplatin, and 5-Fluorouracil in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma

October 20, 2008 updated by: McGill University

The primary purpose of the study is to determine the impact of chemotherapy on the ability of your surgeon to completely remove the cancer as well as the impact on your survival. Furthermore the investigators will be assessing the side effects of this chemotherapy strategy. Finally the investigators will determine the ability of specialized imaging technology (PET scan) to document and predict the response of the tumor to this chemotherapy.

Standard therapy for patients with your condition usually consists of surgery (removal of the tumor) followed by combination chemotherapy and radiotherapy. More recently, standard options available to patients with cancer of the stomach or lower esophagus have been expanded to include chemotherapy without radiotherapy prior to and following surgery. While it is believed that chemotherapy prior to surgery is a good option for patients with stomach, it is not known what is the optimal chemotherapy regimen to offer patients prior to surgery to improve the likelihood of cure while limiting side-effects to patients.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

30

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 Contact

Study Contact Backup

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2W 1S6

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

19 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Histological diagnosis of adenocarcinoma of the stomach, gastroesophageal junction (GEJ), or lower third of the esophagus.
  • The tumour must be deemed by the team to be potentially resectable. This includes imaging studies (detailed below) to clinically stage the tumour and rule-out the presence of metastatic disease, and includes a preoperative laparoscopic evaluation.
  • Stage IB (T1N1 only), II, IIIA, IIIB, and IV (T4N1 only)
  • Life expectancy greater than 3 months
  • ECOG performance status of 1 or better (i.e. restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work).
  • Adequate hematologic reserve: Platelet count 100,000/L, WBC 2000/μL
  • Creatinine clearance 60 ml/min, AST & ALT 2 ULN, Alkaline phosphatase 2.5 ULN, bilirubin ULN

Exclusion Criteria:

  • Prior systemic therapy for gastric cancer
  • Prior docetaxel-containing chemotherapy
  • Pre-existing medical conditions precluding treatment, including any contraindication for major surgery
  • Pregnancy or lactating mothers. Women of childbearing age must use contraception during and for 3 months following treatment.
  • Unable to give informed consent
  • Patients that are not able to maintain nutrition by oral consumption of food alone must have additional enteral feeding.
  • Patients with macroscopic disease noted at laparoscopy
  • ECOG performance status of 2 or higher
  • Significant hearing impairment, as judged by the need for or use of a hearing aid. If there is any uncertainty regarding the degree of hearing impairment, an audiogram will be done. If the audiogram is grossly normal or shows only minor hearing impairment (i.e. not requiring hearing aid), the patient may be enrolled.
  • Unwillingness to undergo investigations and/or treatment as outlined on the study

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
To determine the impact of chemotherapy on the ability of your surgeon to completely remove the cancer as well as the impact on your survival.

Collaborators and Investigators

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

Sponsor

McGill University

Investigators

  • Principal Investigator: Lorenzo Ferri, McGill University

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

April 1, 2007

Primary Completion (Anticipated)

December 1, 2010

Study Registration Dates

First Submitted

September 30, 2008

First Submitted That Met QC Criteria

September 30, 2008

First Posted (Estimate)

October 1, 2008

Study Record Updates

Last Update Posted (Estimate)

October 21, 2008

Last Update Submitted That Met QC Criteria

October 20, 2008

Last Verified

September 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • McG 0620
  • 116082

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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