- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01938105
Preoperative Chemoradiotherapy Combined With Nimotuzumab for Cervical Cancer
Preoperative Concurrent Chemoradiotherapy Combined With Nimotuzumab Injection for Locally Advanced Cervical Cancer: a Phase II Study
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Guangxi
-
Nanning, Guangxi, China, 530021
- Recruiting
- People's Hospital of Guangxi Zhuang Autonomous Region
-
Contact:
- Heming Lu, MS
- Phone Number: +86-771-218-6503
- Email: gxheminglu@sina.com
-
Principal Investigator:
- Heming Lu, MS
-
Principal Investigator:
- Yun Mo, MS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. -------------------------------------------------------------------------------- |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Treatment related toxicities
Time Frame: at 1 year
|
Acute and chronic toxicities.
|
at 1 year
|
Tumor response after preoperative treatment
Time Frame: assessed at 4-5 weeks after the completion of preoperative treatment
|
assessed at 4-5 weeks after the completion of preoperative treatment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Progression-free survival
Time Frame: at 1 year
|
at 1 year
|
Overall survival
Time Frame: at 1 year
|
at 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Heming Lu, MS, People's Hospital of Guangxi
- Principal Investigator: Heming Lu, MS, People's Hospital of Guangxi
- Principal Investigator: Yun Mo, MS, People's Hospital of Guangxi
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- WJPMF-2013-428-2081
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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