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

Primary Purpose

Gastric Junction Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

Status

Unknown status

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Taxotere, Cisplatin, and 5-FU

About this trial

This is an interventional treatment trial for Gastric Junction Adenocarcinoma focused on measuring Gastric or Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

McGill UniversityRecruiting

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00763646

First Posted

September 30, 2008

Last Updated

October 20, 2008

Sponsor

McGill University

1. Study Identification

Unique Protocol Identification Number

NCT00763646

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2008

Overall Recruitment Status

Unknown status

Study Start Date

April 2007 (undefined)

Primary Completion Date

December 2010 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

McGill University

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gastric Junction Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma

Keywords

Gastric or Gastroesophageal Junction Adenocarcinoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Taxotere, Cisplatin, and 5-FU

Intervention Description

Taxotere/Cisplatin/5-FU x 3 cycles (3 weeks per cycle or 9 weeks total), 1 - 2 weeks, Taxotere/Cisplatin/5-FU x 3 cycles (3 weeks per cycle or 9 weeks total)

Primary Outcome Measure Information:

Title

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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Lorenzo Ferri

Phone

514-934-1934

Ext

44327

lorenzo.ferri@muhc.mcgill.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Steven Ades

steven.ades@vtmednet.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lorenzo Ferri

Organizational Affiliation

McGill University

Official's Role

Principal Investigator

Facility Information:

Facility Name

McGill University

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H2W 1S6

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Penny Chipman

Phone

514398-1444

penny.chipman@mcgill.ca

First Name & Middle Initial & Last Name & Degree

Crystal Lameira

Phone

514-398-2229

crystal.lameira@mcgill.ca

First Name & Middle Initial & Last Name & Degree

Lorenzo Ferri

12. IPD Sharing Statement

Learn more about this trial

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

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