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NCT01928290 · ClinicalTrials.gov registry record · Phase 2
Combination Chemotherapy in Treating Patients With Advanced Stomach, Gastroesophageal, or Esophageal Cancer
A Phase 2 study of Esophageal Neoplasms and Stomach Neoplasms, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 67
- Enrollment target
- 1
- Study location
NCT01928290: Completed Phase 2 study of Esophageal Neoplasms and Stomach Neoplasms, sponsored by Washington University School of Medicine.
NCT01928290 is a Phase 2 study of Esophageal Neoplasms and Stomach Neoplasms that has completed, run by Washington University School of Medicine. The registered enrollment target is 67 participants, below the 1,483-participant average among 12 other Esophageal Neoplasms trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01928290, a Phase 2 study of Esophageal Neoplasms and Stomach Neoplasms, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 67 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial studies how well combination chemotherapy works in treating patients with advanced stomach, gastroesophageal, or esophageal cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.
Primary Outcome
* Objective response (defined as complete response (CR) + partial response (PR) by RECIST 1.1 criteria) * CR: Disappearance of all target lesions, non-target lesions, and normalization of tumor marker level. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. * PR: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
Conditions Studied
Interventions
- DRUG Trastuzumab
- DRUG Fluorouracil
- DRUG Leucovorin
- DRUG Oxaliplatin
- DRUG Irinotecan
Study Locations (1)
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 67 participants |
| Start Date | 2013-11-08 |
| Est. Completion | 2019-10-28 |
| Phase | Phase 2 |
What the finished NCT01928290 record still lists
NCT01928290 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 67 participants, a relatively small participant target, below the 1,483-participant average among 12 other Esophageal Neoplasms trials with a reported enrollment target (95% lower).
The record links to 2 conditions, with Esophageal Neoplasms appearing as the primary indexed condition, and to 5 interventions - of which Trastuzumab is the first listed.
NCT01928290 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT01928290 about?
NCT01928290 is a clinical study titled "Combination Chemotherapy in Treating Patients With Advanced Stomach, Gastroesophageal, or Esophageal Cancer". This phase II trial studies how well combination chemotherapy works in treating patients with advanced stomach, gastroesophageal, or esophageal cancer. Drugs used in chemotherapy, such as irinotecan hydrochloride, oxaliplatin, leucovorin calcium, and fluorouracil, work in different ways to stop the ...
What is the current status of trial NCT01928290?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 67 participants. The study started on 2013-11-08. Estimated completion is 2019-10-28.
What conditions does trial NCT01928290 study?
This clinical trial studies the following conditions: Esophageal Neoplasms, Stomach Neoplasms.
What interventions are being tested in trial NCT01928290?
The interventions under investigation include: Trastuzumab (DRUG), Fluorouracil (DRUG), Leucovorin (DRUG), Oxaliplatin (DRUG), Irinotecan (DRUG).
Who is sponsoring clinical trial NCT01928290?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01928290 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01928290's enrollment target sits among peer trials
67 10th of 12 higher than 3 of 12 other Esophageal Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Esophageal Neoplasms 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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