Ignite Creation Date:
2025-12-24 @ 10:31 PM
Ignite Modification Date:
2025-12-25 @ 8:04 PM
Study NCT ID:
NCT01591135
Status:
COMPLETED
Last Update Posted:
2018-10-18
First Post:
2012-04-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase III Study of Comparing Paclitaxel Plus 5-Fluorouracil Versus Cisplatin Plus 5-Fluorouracil in Chemoradiotherapy for Locally Advanced Esophageal Carcinoma
Sponsor:
Fudan University
Organization:
Study Overview
Official Title:
A Phase III Randomized Clinical Trial of Comparing Paclitaxel Plus 5-Fluorouracil Versus Cisplatin Plus 5-Fluorouracil in Chemoradiotherapy for Patients With Locally Advanced Esophageal Squamous Cell Carcinoma
Status:
COMPLETED
Status Verified Date:
2018-10
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:
The primary objective of this trial is to study whether paclitaxel plus 5-fluorouracil has better overall survival than cisplatin plus 5-fluorouracil in chemoradiotherapy for patients with locally advanced esophageal squamous cell carcinoma. 436 patients will be recruited into this study.
Detailed Description:
Locally advanced esophageal squamous cell carcinoma. T2-4N0-1M0-1a,TxN1M0-1a，TxNxM1a （according to AJCC2002）
Scheme:
Eligible recurrent patients with esophageal cancer will first be stratified by nodal staging (N0 or N1), then randomized to 2 arms at 1:1 ratio.
Arm Cisplatin:
Chemoradiotherapy with cisplatin and 5-fluorouracil for 4 cycles.
Arm Paclitaxel:
Chemoradiotherapy with weekly paclitaxel and 5-fluorouracil for 5 weeks followed by adjuvant chemotherapy for 2 cycles.
Scheme:
Eligible recurrent patients with esophageal cancer will first be stratified by nodal staging (N0 or N1), then randomized to 2 arms at 1:1 ratio.
Arm Cisplatin:
Chemoradiotherapy with cisplatin and 5-fluorouracil for 4 cycles.
Arm Paclitaxel:
Chemoradiotherapy with weekly paclitaxel and 5-fluorouracil for 5 weeks followed by adjuvant chemotherapy for 2 cycles.
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?: