Ignite Creation Date:
2024-05-06 @ 3:55 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02409186
Status:
UNKNOWN
Last Update Posted:
2016-04-21
First Post:
2014-12-03
Brief Title:
A Phase III Study of Nimotuzumab Plus Concurrent Chemoradiotherapy in Loco-regional Esophageal Squamous Cell Carcinoma
Sponsor:
Shandong Cancer Hospital and Institute
Organization:
Shandong Cancer Hospital and Institute
Study Overview
Official Title:
A Randomized Controlled Double-blind Study to Evaluate Efficacy and Survival of Combining Nimotuzumab Plus Concurrent Chemo-radiotherapy in Loco-regional Esophageal Squamous Cell Carcinoma
Status:
UNKNOWN
Status Verified Date:
2016-04
Last Known Status:
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:
Esophageal cancer is the sixth leading cause of cancer death in worldwide Over the past 2 decades well-designed clinical trials have documented the clinical benefits of combination of chemotherapy and radiation for localized esophageal cancer either as primary therapy or in neoadjuvant setting Paclitaxel a radiation sensitizer has important single-agent activity in esophageal cancer Paclitaxel-based chemoradiation has been the framework for the recent Radiation Therapy Oncology Group RTOG trials of nonoperative management of esophageal cancer Accumulating clinical evidence suggests that Epidermal Growth Factor Receptor EGFR represents a viable target in the treatment of esophageal cancer EGFR expression is associated with poor prognosis Nimotuzumab binds specifically to EGFR on both normal and tumor cells and competitively inhibits the binding of Epidermal Growth Factor EGF and other ligands such as Transforming Growth Factor-α TGF-α Preclinical models have suggested synergy between nimotuzumab paclitaxel cisplatin and radiation For our phase II study in locally advanced esophageal squamous cell carcinoma ESCC the combination of cetuximab and chemoradiotherapy has demonstrated both response and survival benefits Myara et al reported that nimotuzumab plus concurrent chemoradiation therapy CCRT was safe and provided statistically significant objective response 478 and disease control rate 609 in nonresectable ESCC With all these the investigators plan to study phase III trial
Detailed Description:
The primary endpoint of this study is overall survival and the primary hypothesis is the experimental arm will improve median survival time MST from 182 month to 285 month Assuming bilateral ɑ 005 statistical power of 80Each group requires a minimum of 59 cases Consider the 20 loss factorThe total sample size is 200 casesIt is 100 cases in each group
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