Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00139633
Status:
UNKNOWN
Last Update Posted:
2005-08-31
First Post:
2005-08-29
Brief Title:
Selective Dose Escalation for Esophageal Cancer
Sponsor:
The Oregon Clinic
Organization:
The Oregon Clinic
Study Overview
Official Title:
Phase II Selective Dose Escalation of Chemoradiotherapy for Esophageal Cancer
Status:
UNKNOWN
Status Verified Date:
2005-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective study was designed to assess the outcomes survival and failure patterns of therapy for localized esophageal cancer with conventional dose radiation RT 504 Gy with concurrent continuous infusion 5-fluorouracil 5-FU and weekly carboplatinpaclitaxel Patients with less than complete response CR or partial response PR received dose escalation of radiation to 594 Gy with the same chemotherapy
Detailed Description:
we prospectively enrolled patients with T1-4 N0-1 M0-1a esophageal carcinoma to receive paclitaxel 45 mgm2 IV over 1 hour and carboplatin AUC 2 IV over 30 minutes on days 1 8 15 22 29 and 36 5-FU 225mgm2 was delivered as a continuous infusion on days 1-38 RT was given 18Gy 5 dayswk for 55 wks 504Gy in 28 fx After 6-8 weeks patients underwent repeat staging with computed tomography CT scan endoscopic ultrasound EUS and biopsy Patients with a positive biopsy or less than PR by CT and EUS received a boost of 9 Gy with the same concurrent chemotherapy Patients were followed every 4 months with CTEUS first year every 6 months thereafter
Study Oversight
Has Oversight DMC:
None
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?:
None