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NCT00515411 · ClinicalTrials.gov registry record · Phase 2
Study of Modified Docetaxel, Cisplatin, and Fluorouracil (mDCF) in Unresectable or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma
A Phase 2 study of Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 111
- Enrollment target
- 15
- Study locations
NCT00515411: Completed Phase 2 study of Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
NCT00515411 is a Phase 2 study of Gastric Cancer and Gastroesophageal Junction Adenocarcinoma that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 111 participants, below the 319-participant average among 153 other Gastric Cancer trials with a reported enrollment target (65% lower). The trial reports 15 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00515411, a Phase 2 study of Gastric Cancer and Gastroesophageal Junction Adenocarcinoma, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 111 participants
- Enrollment target
- 15
- Study locations
Study Summary
Chemotherapy given together is a standard way to treat your cancer. One standard treatment includes a combination of docetaxel, cisplatin, and fluorouracil. However, the original combination of these three drugs can cause many side effects. This study is being done to find out if these three drugs can be given at lower doses more often, with fewer side effects and still maintain the same benefit as the standard way of giving this three drug combination. If your tumor overexpresses a protein called Her2, you are also eligible to receive trastuzumab with chemotherapy. Trastuzumab is a medicine that has been approved by the US Food and Drug Administration for the treatment of Her2 positive breast cancer. Trastuzumab is now also a standard treatment in combination with chemotherapy for the treatment of Her2 positive stomach cancer. If your tumor is Her2 positive, you would receive the modified administration schedule of docetaxel, cisplatin, and fluorouracil with trastuzumab.
Primary Outcome
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions", or similar definition as accurate and appropriate
Conditions Studied
Interventions
- DRUG Docetaxel, Leucovorin, Fluorouracil, Cisplatin
- DRUG Docetaxel, Cisplatin, Fluorouracil, Neulasta, or Neupogen
- DRUG Docetaxel, Leukvorin, Flurouracil, Cisplatin, Trastuzumab
Study Locations (15)
New York
- Memorial Sloan-Kettering Cancer Center @ Suffolk - Commack
- Queens Cancer Center of Queens Hospital - Jamaica
- Long Island Jewish Medical Center - New Hyde Park
- Weill Medical College of Cornell University - New York
- Memorial Sloan Kettering Cancer Center 1275 York Avenue - New York
- Memorial Sloan Kettering at Mercy Medical Center - Rockville Centre
- Memoral Sloan Kettering Cancer Center@Phelps Memorial Hospital - Sleepy Hollow
California
- City of Hope Cancer Center - Duarte
Florida
- Memorial Cancer Institute - Pembroke Pines
Georgia
- Piedmont Hospital Research Institute - Atlanta
Nebraska
- Nebraska Cancer Specialists, Methodist Estabrook Cancer Center - Omaha
New Jersey
- Memoral Sloan Kettering Cancer Center - Basking Ridge
Ohio
- University Hospital of Cleveland - Cleveland
Pennsylvania
- University of Pittsburgh Cancer Institute - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2006-10-23 |
| Est. Completion | 2018-10-26 |
| Phase | Phase 2 |
What the finished NCT00515411 record still lists
NCT00515411 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, below the 319-participant average among 153 other Gastric Cancer trials with a reported enrollment target (65% lower).
The record links to 2 conditions, with Gastric Cancer appearing as the primary indexed condition, and to 3 interventions - of which Docetaxel, Leucovorin, Fluorouracil, Cisplatin is the first listed.
NCT00515411 lists 15 locations in 9 states (New York, California, Florida).
Frequently Asked Questions
What is clinical trial NCT00515411 about?
NCT00515411 is a clinical study titled "Study of Modified Docetaxel, Cisplatin, and Fluorouracil (mDCF) in Unresectable or Metastatic Gastric and Gastroesophageal Junction Adenocarcinoma". Chemotherapy given together is a standard way to treat your cancer. One standard treatment includes a combination of docetaxel, cisplatin, and fluorouracil. However, the original combination of these three drugs can cause many side effects. This study is being done to find out if these three drugs c...
What is the current status of trial NCT00515411?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 111 participants. The study started on 2006-10-23. Estimated completion is 2018-10-26.
What conditions does trial NCT00515411 study?
This clinical trial studies the following conditions: Gastric Cancer, Gastroesophageal Junction Adenocarcinoma.
What interventions are being tested in trial NCT00515411?
The interventions under investigation include: Docetaxel, Leucovorin, Fluorouracil, Cisplatin (DRUG), Docetaxel, Cisplatin, Fluorouracil, Neulasta, or Neupogen (DRUG), Docetaxel, Leukvorin, Flurouracil, Cisplatin, Trastuzumab (DRUG).
Who is sponsoring clinical trial NCT00515411?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00515411 being conducted?
This trial has 15 study locations across California, Florida, Georgia, Nebraska, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00515411's enrollment target sits among peer trials
111 83rd of 153 higher than 71 of 153 other Gastric Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastric Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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