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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00763646
Recruitment Status : Unknown
Verified September 2008 by McGill University.
Recruitment status was:  Recruiting
First Posted : October 1, 2008
Last Update Posted : October 21, 2008
Sponsor:
Information provided by:
McGill University

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.


Condition or disease Intervention/treatment Phase
Gastric Junction Adenocarcinoma Gastroesophageal Junction Adenocarcinoma Drug: Taxotere, Cisplatin, and 5-FU Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Neoadjuvant Taxotere, Cisplatin, and 5-Fluorouracil in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
Study Start Date : April 2007
Estimated Primary Completion Date : December 2010

Resource links provided by the National Library of Medicine



Intervention Details:
  • Drug: 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 Measures :
  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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763646


Contacts
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Contact: Lorenzo Ferri 514-934-1934 ext 44327 lorenzo.ferri@muhc.mcgill.ca
Contact: Steven Ades steven.ades@vtmednet.org

Locations
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Canada, Quebec
McGill University Recruiting
Montreal, Quebec, Canada, H2W 1S6
Contact: Penny Chipman    514398-1444    penny.chipman@mcgill.ca   
Contact: Crystal Lameira    514-398-2229    crystal.lameira@mcgill.ca   
Principal Investigator: Lorenzo Ferri         
Sponsors and Collaborators
McGill University
Investigators
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Principal Investigator: Lorenzo Ferri McGill University
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Responsible Party: Dr. Lorenzo Ferri, McGill University
ClinicalTrials.gov Identifier: NCT00763646    
Other Study ID Numbers: McG 0620
116082
First Posted: October 1, 2008    Key Record Dates
Last Update Posted: October 21, 2008
Last Verified: September 2008
Keywords provided by McGill University:
Gastric or Gastroesophageal Junction Adenocarcinoma
Additional relevant MeSH terms:
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Adenocarcinoma
Esophageal Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Docetaxel
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action