Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:48 AM
Study NCT ID:
NCT01372202
Status:
TERMINATED
Last Update Posted:
2019-01-25
First Post:
2011-06-09
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
CHFR Methylation Status Esophageal Cancer Study
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Study Overview
Official Title:
A Phase 2 Study of Paclitaxel With Cisplatin Versus Fluoropyrimidine With a Platinum Agent for Neoadjuvant Therapy in Operable Esophageal Cancer Based on CHFR Methylation Status in Diagnostic Biopsies
Status:
TERMINATED
Status Verified Date:
2019-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study stopped due to early stopping rule
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
J10130
Brief Summary:
This is a Phase 2 Study of Paclitaxel with Cisplatin versus Fluoropyrimidine with a Platinum Agent for Neoadjuvant Therapy in Operable Esophageal Cancer Based on CHFR Methylation Status in Diagnostic Biopsies.
Detailed Description:
Primary Objectives
• To determine the rate of pathological complete response when the inclusion of paclitaxel in neoadjuvant therapy is based on the presence or absence of CHFR methylation in diagnostic biopsy specimens.
Secondary Objectives
* To determine the survival outcome with this treatment strategy.
* To determine time to disease progression with this treatment strategy.
* To determine the agreement between tumor CHFR methylation and detection in plasma.
• To determine the rate of pathological complete response when the inclusion of paclitaxel in neoadjuvant therapy is based on the presence or absence of CHFR methylation in diagnostic biopsy specimens.
Secondary Objectives
* To determine the survival outcome with this treatment strategy.
* To determine time to disease progression with this treatment strategy.
* To determine the agreement between tumor CHFR methylation and detection in plasma.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NA_00042668 | OTHER | JHMIRB | View | |
| R33CA127055 | NIH | None | https://reporter.nih.gov/quic… | View |