Phase II Study of Neoadjuvant Taxotere, Cisplatin, and 5-Fluorouracil in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
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|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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- 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)
- 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.
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
|Contact: Lorenzo Ferri||514-934-1934 ext email@example.com|
|Contact: Steven Adesfirstname.lastname@example.org|
|Principal Investigator:||Lorenzo Ferri||McGill University|