Back to resultsPreoperative Chemoradiotherapy Combined With Nimotuzumab for Cervical Cancer
Primary Purpose
Locally Advanced Cervical Cancer
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Nimotuzumab+chemoradiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Locally Advanced Cervical Cancer focused on measuring Cervical cancer, Nimotuzumab, Intensity-modulated radiation therapy, Concurrent chemoradiotherapy
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
Sites / Locations
- People's Hospital of Guangxi Zhuang Autonomous RegionRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nimotuzumab+chemoradiotherapy
Arm Description
Outcomes
Primary Outcome Measures
Treatment related toxicities
Acute and chronic toxicities.
Tumor response after preoperative treatment
Secondary Outcome Measures
Progression-free survival
Overall survival
Full Information
NCT ID
NCT01938105
First Posted
September 4, 2013
Last Updated
September 24, 2013
Sponsor
People's Hospital of Guangxi
Collaborators
Wu Jieping Medical Foundation
1. Study Identification
Unique Protocol Identification Number
NCT01938105
Brief Title
Preoperative Chemoradiotherapy Combined With Nimotuzumab for Cervical Cancer
Official Title
Preoperative Concurrent Chemoradiotherapy Combined With Nimotuzumab Injection for Locally Advanced Cervical Cancer: a Phase II Study
Study Type
Interventional
2. Study Status
Record Verification Date
September 2013
Overall Recruitment Status
Unknown status
Study Start Date
July 2013 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
People's Hospital of Guangxi
Collaborators
Wu Jieping Medical Foundation
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Locally Advanced Cervical Cancer
Keywords
Cervical cancer, Nimotuzumab, Intensity-modulated radiation therapy, Concurrent chemoradiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nimotuzumab+chemoradiotherapy
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Nimotuzumab+chemoradiotherapy
Intervention 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.
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Primary Outcome Measure Information:
Title
Treatment related toxicities
Description
Acute and chronic toxicities.
Time Frame
at 1 year
Title
Tumor response after preoperative treatment
Time Frame
assessed at 4-5 weeks after the completion of preoperative treatment
Secondary Outcome Measure Information:
Title
Progression-free survival
Time Frame
at 1 year
Title
Overall survival
Time Frame
at 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heming Lu, MS
Phone
+86-771-218-6503
Email
gxheminglu@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heming Lu, MS
Organizational Affiliation
People's Hospital of Guangxi
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Heming Lu, MS
Organizational Affiliation
People's Hospital of Guangxi
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Yun Mo, MS
Organizational Affiliation
People's Hospital of Guangxi
Official's Role
Principal Investigator
Facility Information:
Facility Name
People's Hospital of Guangxi Zhuang Autonomous Region
City
Nanning
State/Province
Guangxi
ZIP/Postal Code
530021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heming Lu, MS
Phone
+86-771-218-6503
Email
gxheminglu@sina.com
First Name & Middle Initial & Last Name & Degree
Heming Lu, MS
First Name & Middle Initial & Last Name & Degree
Yun Mo, MS
12. IPD Sharing Statement
Learn more about this trial
Preoperative Chemoradiotherapy Combined With Nimotuzumab for Cervical Cancer
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