Recruiting
Phase 2

Taxotere, Cisplatin, 5-Fluorouracil

Sponsor:

McGill University

Code:

NCT00763646

Conditions

Gastric Junction Adenocarcinoma

Gastroesophageal Junction Adenocarcinoma

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

Interventions

Taxotere, Cisplatin, and 5-FU

Study Details

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.

Conditions

Gastric Junction Adenocarcinoma

Gastroesophageal Junction Adenocarcinoma

Study ID

NCT00763646

Start date

Apr, 2007

Status verified date

Sep, 2008

Primary completion date

Dec, 2010

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 19 - 70+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Taxotere, Cisplatin, and 5-FU

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

  • 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: undefined ]

Central Contacts and Locations

Central contacts

Lorenzo Ferri

514-934-1934lorenzo.ferri@muhc.mcgill.ca

Steven Ades

steven.ades@vtmednet.org

Locations

McGill University

Recruiting

Montreal, Quebec, Canada, H2W 1S6

Contacts

Penny Chipman

514398-1444penny.chipman@mcgill.ca

Crystal Lameira

514-398-2229crystal.lameira@mcgill.ca

Principal Investigator:

Lorenzo Ferri

More Information

Sponsor

McGill University

Last update posted

Oct 21, 2008

Last verified

Sep, 2008

Keywords

  • Gastric or Gastroesophageal Junction Adenocarcinoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McGill University on 2008-10-21.