Ignite Creation Date:
2024-05-05 @ 11:19 PM
Last Modification Date:
2024-10-26 @ 10:32 AM
Study NCT ID:
NCT01301612
Status:
WITHDRAWN
Last Update Posted:
2014-07-14
First Post:
2011-02-21
Brief Title:
Study of Nimotuzumab Radiation Therapy and Cisplatin Versus Radiation Therapy and Cisplatin for Treatment of Stage IB e IVA UCCCORUS
Sponsor:
Eurofarma Laboratorios SA
Organization:
Eurofarma Laboratorios SA
Study Overview
Official Title:
A Phase II Multicenter RandomizedTwo-Arm Clinical Study An Investigational Arm Containing Nimotuzumab in Combination With Radiotion Therapy and Cisplatyn and a Control Arm With Radiation Therapy and Cisplatin for the Definitive Treatment of Stage IB and IVA Uterine Cervical Carcinoma
Status:
WITHDRAWN
Status Verified Date:
2012-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Regulatory requirement A phase III study is being designed
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The primary study objective will be to assess the efficacy of the combination of radiation therapy with nimotuzumab and cisplatin as compared to the combination of radiation therapy plus cisplatin in the treatment of Uterine Cervical Carcinoma UCC
The secondary study objectives will be safety and tolerability evaluations to determine treatment feasibility and the interim efficacy evaluation according to other parameters routinely used in oncology
The secondary study objectives will be safety and tolerability evaluations to determine treatment feasibility and the interim efficacy evaluation according to other parameters routinely used in oncology
Detailed Description:
This will be a phase II randomized controlled open-label multicenter and two-arm study The study will be conducted in Brazil and has the purpose of determining the activity and safety of nimotuzumab in terms of overall and distant disease-free survival radiological and clinical gynecological examinations as well as by biopsy if indicated progression-free survival local control of long-term disease frequency of treatment-emergent adverse events frequency of severe treatment-emergent adverse events
All participating patients will sign a consent form before they undergo any study-related procedureThe eligible patients will have stage IB and IVA uterine cervical carcinoma and they will be randomized to one of two treatment groups
Randomization and treatment assignment will be performed by a company specifically contracted for such purpose and will be per research site and disease stage IB2 to IIIA versus IIIB to IVA 11
All participating patients will sign a consent form before they undergo any study-related procedureThe eligible patients will have stage IB and IVA uterine cervical carcinoma and they will be randomized to one of two treatment groups
Randomization and treatment assignment will be performed by a company specifically contracted for such purpose and will be per research site and disease stage IB2 to IIIA versus IIIB to IVA 11
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