Phase II Study of Neoadjuvant Taxotere, Cisplatin, and 5-Fluorouracil in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by McGill University.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
McGill University
Information provided by:
McGill University
ClinicalTrials.gov Identifier:
NCT00763646
First received: September 30, 2008
Last updated: October 20, 2008
Last verified: September 2008
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Gastric Junction Adenocarcinoma Gastroesophageal Junction Adenocarcinoma |
Drug: Taxotere, Cisplatin, and 5-FU |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: 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 |
Resource links provided by NLM:
Further study details as provided by McGill University:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | April 2007 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
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)
Eligibility| Ages Eligible for Study: | 19 Years to 80 Years |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00763646
Contacts
| Contact: Lorenzo Ferri | 514-934-1934 ext 44327 | lorenzo.ferri@muhc.mcgill.ca |
| Contact: Steven Ades | steven.ades@vtmednet.org |
Locations
| 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
| Principal Investigator: | Lorenzo Ferri | McGill University |
More Information
No publications provided
| Responsible Party: | Dr. Lorenzo Ferri, McGill University |
| ClinicalTrials.gov Identifier: | NCT00763646 History of Changes |
| Other Study ID Numbers: | McG 0620, 116082 |
| Study First Received: | September 30, 2008 |
| Last Updated: | October 20, 2008 |
| Health Authority: | Canada: Health Canada |
Keywords provided by McGill University:
|
Gastric or Gastroesophageal Junction Adenocarcinoma |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Docetaxel Cisplatin Fluorouracil |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Radiation-Sensitizing Agents Physiological Effects of Drugs Antimetabolites Molecular Mechanisms of Pharmacological Action Antimetabolites, Antineoplastic Immunosuppressive Agents Immunologic Factors |
ClinicalTrials.gov processed this record on June 18, 2013