Preoperative Chemoradiotherapy Combined With Nimotuzumab for Cervical Cancer
NCT ID: NCT01938105
Last Updated: 2013-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
40 participants
INTERVENTIONAL
2013-07-31
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Nimotuzumab+chemoradiotherapy
Nimotuzumab+chemoradiotherapy
Nimotuzumab 200mg per week will be administered concurrent with platinum-based chemotherapy and intensity-modulated radiation therapy. After the preoperative treatment, patients will be assessed for tumor response and operability. For those who are considered to be candidates for operation, radical surgery will be performed.
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Interventions
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Nimotuzumab+chemoradiotherapy
Nimotuzumab 200mg per week will be administered concurrent with platinum-based chemotherapy and intensity-modulated radiation therapy. After the preoperative treatment, patients will be assessed for tumor response and operability. For those who are considered to be candidates for operation, radical surgery will be performed.
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Eligibility Criteria
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Inclusion Criteria
* Stages IB2-IIIB according to FIGO Staging System
* Age:18-75
* ECOG\<2
* Normal bone marrow function
* Initial assessed and considered not candidates for operation
* Signed study-specific consent form
Exclusion Criteria
* Patients with other malignancies
* Patients who received radiotherapy or chemotherapy previously
* Presence of uncontrolled life-threatening illness
* Allergy to platinum or monoclonal antibody
18 Years
75 Years
ALL
No
Sponsors
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Wu Jieping Medical Foundation
OTHER
People's Hospital of Guangxi Zhuang Autonomous Region
OTHER
Responsible Party
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Heming Lu
Associate Professor
Principal Investigators
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Heming Lu, MS
Role: STUDY_CHAIR
People's Hospital of Guangxi Zhuang Autonomous Region
Heming Lu, MS
Role: PRINCIPAL_INVESTIGATOR
People's Hospital of Guangxi Zhuang Autonomous Region
Yun Mo, MS
Role: PRINCIPAL_INVESTIGATOR
People's Hospital of Guangxi Zhuang Autonomous Region
Locations
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People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Countries
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Central Contacts
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Facility Contacts
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Heming Lu, MS
Role: primary
Other Identifiers
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WJPMF-2013-428-2081
Identifier Type: -
Identifier Source: org_study_id