Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00193128
Status:
COMPLETED
Last Update Posted:
2021-11-24
First Post:
2005-09-12
Brief Title:
Preoperative Therapy With OxaliplatinDocetaxelCapecitabine and Radiation in Resectable Esophagus Cancer
Sponsor:
SCRI Development Innovations LLC
Organization:
SCRI Development Innovations LLC
Study Overview
Official Title:
A Phase III Trial of Preoperative Oxaliplatin Docetaxel and Capecitabine With Concurrent Radiation Therapy in Localized Carcinoma of the Esophagus or Gastroesophageal Junction
Status:
COMPLETED
Status Verified Date:
2021-10
Last Known Status:
None
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:
In this phase III trial we will evaluate a novel combination of chemotherapy used concurrently with radiation therapy in the preoperative therapy of locoregional carcinoma of the esophagus and gastroesophageal junction In the brief phase I portion of this trial we will determine whether 2 drugs docetaxeloxaliplatin or 3 drugs docetaxeloxaliplatincapecitabine can be used concurrently with radiation therapy If the 3-drug regimen is tolerated the phase II portion will proceed with this regimen If the 3-drug combination is considered too toxic the phase II study will proceed with docetaxeloxaliplatin in combination with radiation therapy
Detailed Description:
Upon determination of eligibility patients will be receive
Oxaliplatin Docetaxel Capecitabine Radiation therapy
If the three-drug chemotherapy regimen with radiation therapy is tolerable this regimen will be taken forward into the phase II portion of the trial If the three-drug regimen is too toxic the phase II portion will proceed with the two-drug regimen Oxaliplatin Docetaxel Radiation therapy
Oxaliplatin Docetaxel Capecitabine Radiation therapy
If the three-drug chemotherapy regimen with radiation therapy is tolerable this regimen will be taken forward into the phase II portion of the trial If the three-drug regimen is too toxic the phase II portion will proceed with the two-drug regimen Oxaliplatin Docetaxel Radiation therapy
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