Status:
UNKNOWN
Phase II Study of Neoadjuvant Taxotere, Cisplatin, and 5-Fluorouracil in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
Lead Sponsor:
McGill University
Conditions:
Gastric Junction Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Eligibility:
All Genders
19-80 years
Phase:
PHASE2
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 inves...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT00763646
Start Date
April 1 2007
Last Update
October 21 2008
Active Locations (1)
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1
McGill University
Montreal, Quebec, Canada, H2W 1S6