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Preoperative Chemoradiotherapy Combined With Nimotuzumab for Cervical Cancer
Conditions
Locally Advanced Cervical Cancer
Conditions: official terms
Uterine Cervical Neoplasms
Conditions: Keywords
Cervical cancer, Nimotuzumab, Intensity-modulated radiation therapy, Concurrent chemoradiotherapy
Study Type
Interventional
Study Phase
Phase 2
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Nimotuzumab+chemoradiotherapy
Type: Other
Overall Status
Recruiting
Summary
The purpose of this study is to determine the feasibility and efficacy of preoperative nimotuzumab injection combined with concurrent chemoradiotherapy for initially inoperable, locally advanced cervical cancer.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 75 Years
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
- Histologically or cytologically proven squamous cell cervical cancer
- 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:
- Pregnant or lactating women
- Patients with other malignancies
- Patients who received radiotherapy or chemotherapy previously
- Presence of uncontrolled life-threatening illness
- Allergy to platinum or monoclonal antibody
- Histologically or cytologically proven squamous cell cervical cancer
- 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:
- Pregnant or lactating women
- Patients with other malignancies
- Patients who received radiotherapy or chemotherapy previously
- Presence of uncontrolled life-threatening illness
- Allergy to platinum or monoclonal antibody
Location
People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Status: Recruiting
Contact: Heming Lu, MS - +86-771-218-6503 - gxheminglu@sina.com
Start Date
July 2013
Completion Date
June 2016
Sponsors
People's Hospital of Guangxi
Source
People's Hospital of Guangxi
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
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