Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00153881
Status:
COMPLETED
Last Update Posted:
2014-11-13
First Post:
2005-09-07
Brief Title:
Docetaxel and Carboplatin Followed by Oral Capecitabine Docetaxel and Radiation for Esophageal Cancer
Sponsor:
Dartmouth-Hitchcock Medical Center
Organization:
Dartmouth-Hitchcock Medical Center
Study Overview
Official Title:
Docetaxel and Carboplatin Followed by a Dose-Ranging Study of Oral Capecitabine Weekly Docetaxel and Concomitant External Beam Radiotherapy for the Treatment of Patients With Stage II-III Carcinoma of the Esophagus and Gastro-Esophageal Junction
Status:
COMPLETED
Status Verified Date:
2014-11
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:
The primary objective is to determine the maximum tolerated dose of oral capecitabine in combination with fixed doses of weekly docetaxel and concurrent thoracic radiation for the treatment of patients with clinical stage II-III cancer of the esophagus and gastroesophageal junction
Detailed Description:
This dose-ranging trial is designed to establish the phase II dose of capecitabine that can safely be given with docetaxel and radiation therapy for the treatment of patients with cancer of the esophagus and gastroesophageal junction The docetaxel dose of 15 mgm2week 5-fluorouracil dose of 200 mgm2week and 504 Gy of thoracic radiation has been found to be the recommended doses from our initial phase I trial DMS D9724 The Phase I study has been modified in an attempt to improve the pathological complete response rate by increasing the 5-fluorouracil exposure during thoracic radiation by replacing it with oral capecitabine Capecitabine generates 5-fluorouracil selectively in tumor cells This sequentially designed study of EUS staging molecular analysis neoadjuvant chemotherapy concomitant chemotherapy and radiation and surgical resection continues to expand our collaborative experience at Dartmouth Hitchcock in the treatment of cancer of the esophagus and gastroesophageal junction
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