Ignite Creation Date:
2024-05-06 @ 12:01 AM
Last Modification Date:
2024-10-26 @ 10:43 AM
Study NCT ID:
NCT01474642
Status:
COMPLETED
Last Update Posted:
2015-12-29
First Post:
2011-11-10
Brief Title:
Phase II Trial of XP Versus XG in Advanced Esophageal Squamous Cell Carcinoma
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
A Randomized Phase II Trial of Capecitabine Plus Cisplatin XP Versus Capecitabine Plus Genexol XG as a First-line Treatment for Advanced or Recurrent Esophageal Squamous Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2015-12
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:
Until today the 5-FUcisplatin combination is the reference regimen with 30-45 response rates which is most commonly used to treat patients with metastatic recurrent or locally advanced unresectable squamous cell carcinoma of the esophagus Because the classical dose schedule of this two-drug combination is cisplatin 100 mgm2 day 1 and 5-FU 1000 mgm2day continuous infusion for 96-120 hr prolonged administration time and mucosal toxicity are inconvenient to the patients with the aim of palliation Capecitabine which is oral prodrug of 5-FU and mimic continuously-infused 5-FU is being investigated in phase I II and III trials for the treatment of gastric gastroesophageal and esophageal cancers primarily in the first-line metastatic setting but also in the adjuvant setting In the investigators experience capecitabine plus cisplatin combination XP as a first-line treatment for 45 patients with advanced or recurrent esophageal squamous cell carcinoma demonstrated a promising anti-tumor activity with 57 of response rate and showed tolerable toxicity with convenience
Paclitaxel has been also investigated as monotherapy and in combination with cisplatin in patients with advanced esophageal cancer A Dutch phase II study demonstrated that paclitaxel combination with carboplatin had shown an encouraging confirmed response rate of 59 with 51 patients with resectable esophageal cancer in neoadjuvant setting Another Dutch phase II study showed 43 of response rate including 4 of CR with 8 months of response duration when paclitaxel plus cisplatin administration was given for patients with metastatic esophageal cancer Although recently first-line palliative chemotherapy regimen in esophageal cancer has been investigated many trials have failed to show superiority to 5-FUcisplatin combination Since the investigators considered that XP or XG genexol is more effective and convenient chemotherapy regimen than 5-FUcisplatin this randomized phase II study was planned to compare XP with XG in terms of efficacy and tolerability
Paclitaxel has been also investigated as monotherapy and in combination with cisplatin in patients with advanced esophageal cancer A Dutch phase II study demonstrated that paclitaxel combination with carboplatin had shown an encouraging confirmed response rate of 59 with 51 patients with resectable esophageal cancer in neoadjuvant setting Another Dutch phase II study showed 43 of response rate including 4 of CR with 8 months of response duration when paclitaxel plus cisplatin administration was given for patients with metastatic esophageal cancer Although recently first-line palliative chemotherapy regimen in esophageal cancer has been investigated many trials have failed to show superiority to 5-FUcisplatin combination Since the investigators considered that XP or XG genexol is more effective and convenient chemotherapy regimen than 5-FUcisplatin this randomized phase II study was planned to compare XP with XG in terms of efficacy and tolerability
Detailed Description:
None
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