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NCT00062374 · ClinicalTrials.gov registry record · Phase 2
Irinotecan and Cisplatin in Treating Patients Who Are Undergoing Surgery For Locally Advanced Cancer of the Stomach or Gastroesophageal Junction
A Phase 2 study of Gastric Adenocarcinoma and Stage IV Gastric Cancer, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT00062374: Completed Phase 2 study of Gastric Adenocarcinoma and Stage IV Gastric Cancer, sponsored by National Cancer Institute (NCI).
NCT00062374 is a Phase 2 study of Gastric Adenocarcinoma and Stage IV Gastric Cancer that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 55 participants, below the 244-participant average among 47 other Gastric Adenocarcinoma trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00062374, a Phase 2 study of Gastric Adenocarcinoma and Stage IV Gastric Cancer, has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
This phase II trial is studying how well giving irinotecan together with cisplatin works in treating patients who are undergoing surgical resection for locally advanced cancer of the stomach or gastroesophageal junction. Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug and giving them before surgery may shrink the tumor so that it can be removed during surgery.
Primary Outcome
The primary objective was to demonstrate that a decrease in FDG-SUV discriminates treatment response. Response was defined pathologically based on microscopic inspection for residual cancer cells and fibrosis. Using a two sample t-test, we would be able to adequately test that the decrease in SUV early in the treatment plan is significantly different between responders and non responders. Data adjudication was invalid, and needs to be re-adjudicated Non-Responder= Tumor Regression Grade 3 or h
Conditions Studied
Interventions
- PROCEDURE Computed Tomography
- DRUG Cisplatin
- DRUG Irinotecan Hydrochloride
- RADIATION Fludeoxyglucose F-18
- OTHER Fluorothymidine F-18
Study Locations (1)
New York
- Memorial Sloan-Kettering Cancer Center - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2003-06 |
| Est. Completion | 2011-06 |
| Phase | Phase 2 |
What the finished NCT00062374 record still lists
NCT00062374 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 244-participant average among 47 other Gastric Adenocarcinoma trials with a reported enrollment target (77% lower).
The record links to 4 conditions, with Gastric Adenocarcinoma appearing as the primary indexed condition, and to 5 interventions - of which Computed Tomography is the first listed.
NCT00062374 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00062374 about?
NCT00062374 is a clinical study titled "Irinotecan and Cisplatin in Treating Patients Who Are Undergoing Surgery For Locally Advanced Cancer of the Stomach or Gastroesophageal Junction". This phase II trial is studying how well giving irinotecan together with cisplatin works in treating patients who are undergoing surgical resection for locally advanced cancer of the stomach or gastroesophageal junction. Drugs used in chemotherapy, such as irinotecan and cisplatin, work in different...
What is the current status of trial NCT00062374?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2003-06. Estimated completion is 2011-06.
What conditions does trial NCT00062374 study?
This clinical trial studies the following conditions: Gastric Adenocarcinoma, Stage IV Gastric Cancer, Stage III Gastric Cancer, Stage II Gastric Cancer.
What interventions are being tested in trial NCT00062374?
The interventions under investigation include: Computed Tomography (PROCEDURE), Cisplatin (DRUG), Irinotecan Hydrochloride (DRUG), Fludeoxyglucose F-18 (RADIATION), Fluorothymidine F-18 (OTHER).
Who is sponsoring clinical trial NCT00062374?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00062374 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT00062374's enrollment target sits among peer trials
55 25th of 47 higher than 23 of 47 other Gastric Adenocarcinoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gastric Adenocarcinoma 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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