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Trial Title:
Preoperative Chemoradiotherapy Combined With Nimotuzumab for Cervical Cancer
NCT ID:
NCT01938105
Condition:
Locally Advanced Cervical Cancer
Conditions: Official terms:
Uterine Cervical Neoplasms
Nimotuzumab
Conditions: Keywords:
Cervical cancer
Nimotuzumab
Intensity-modulated radiation therapy
Concurrent chemoradiotherapy
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
Nimotuzumab+chemoradiotherapy
Description:
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.
Arm group label:
Nimotuzumab+chemoradiotherapy
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:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
People's Hospital of Guangxi Zhuang Autonomous Region
Address:
City:
Nanning
Zip:
530021
Country:
China
Status:
Recruiting
Contact:
Last name:
Heming Lu, MS
Phone:
+86-771-218-6503
Email:
gxheminglu@sina.com
Investigator:
Last name:
Heming Lu, MS
Email:
Principal Investigator
Investigator:
Last name:
Yun Mo, MS
Email:
Principal Investigator
Start date:
July 2013
Completion date:
June 2016
Lead sponsor:
Agency:
People's Hospital of Guangxi
Agency class:
Other
Collaborator:
Agency:
Wu Jieping Medical Foundation
Agency class:
Other
Source:
People's Hospital of Guangxi
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01938105
