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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00763646
• Date of registration: 30/09/2008
• Primary sponsor: McGill University
• Public title: Phase II Study of Neoadjuvant Taxotere, Cisplatin, and 5-Fluorouracil in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
• Scientific title: Phase II Study of Neoadjuvant Taxotere, Cisplatin, and 5-Fluorouracil in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
• Date of first enrolment: April 2007
• Target sample size: 30
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT00763646
• Study type: Interventional
• Study design: Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Countries of recruitment

Canada

Contacts

• Name: Penny Chipman

• Name: Lorenzo Ferri

• Name: Lorenzo Ferri
• Affiliation: McGill University

Key inclusion & exclusion 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



Age minimum: 19 Years
Age maximum: 80 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Gastric Junction Adenocarcinoma

Gastroesophageal Junction Adenocarcinoma

Intervention(s)

Drug: Taxotere, Cisplatin, and 5-FU

Primary Outcome(s)

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. [Time Frame: unknown]

Secondary ID(s)

116082

McG 0620

Source(s) of Monetary Support

Please refer to primary and secondary sponsors