CClinicalTrials.gg
Status unknownNCT00763646Updated Oct 21, 2008

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

A Phase 2 interventional study of Taxotere, Cisplatin, and 5-FU in Gastric Junction Adenocarcinoma and Gastroesophageal Junction Adenocarcinoma, sponsored by McGill University. Status unknown at 1 site in Canada. Open to participants aged 19 Years to 80 Years. Per ClinicalTrials.gov, last updated 2008-10-21.

Sponsored by McGill University · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2008), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
19 Years to 80 Years
Sex
All
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Study 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.

02

Conditions studied

  • Gastric Junction Adenocarcinoma
  • Gastroesophageal Junction Adenocarcinoma

Keywords

  • Gastric or Gastroesophageal Junction Adenocarcinoma
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In context

Adenocarcinoma

2,004 studies on the registry are indexed under Adenocarcinoma; 375 are open to participants now.

This study's planned enrollment of 30 is below the median of 45 across 1,553 interventional studies indexed under Adenocarcinoma.

Browse Adenocarcinoma studies →

Lead sponsor

McGill University is the lead sponsor of 244 studies on the registry; 49 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Interventions

  • DrugTaxotere, 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)

06

What researchers measure

Primary outcomes

  1. 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.

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Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00763646
Lead sponsor
McGill University
First posted
Oct 1, 2008
Start date
Apr 2007
Primary completion
Dec 2010 (estimated)
Last update
Oct 21, 2008

Study contacts

Lorenzo Ferri
Contact
lorenzo.ferri@muhc.mcgill.ca
514-934-1934 ext. 44327
Steven Ades
Contact
steven.ades@vtmednet.org
Lorenzo Ferri
principal investigator · McGill University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2008. You cannot join it, but the record below documents what was studied.

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