Preoperative Chemoradiotherapy Combined With Nimotuzumab for Cervical Cancer
Preoperative Concurrent Chemoradiotherapy Combined With Nimotuzumab Injection for Locally Advanced Cervical Cancer: a Phase II Study
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Jul 2013
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 4, 2013
CompletedFirst Posted
Study publicly available on registry
September 10, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2016
CompletedSeptember 26, 2013
September 1, 2013
1.9 years
September 4, 2013
September 24, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Treatment related toxicities
Acute and chronic toxicities.
at 1 year
Tumor response after preoperative treatment
assessed at 4-5 weeks after the completion of preoperative treatment
Secondary Outcomes (2)
Progression-free survival
at 1 year
Overall survival
at 1 year
Study Arms (1)
Nimotuzumab+chemoradiotherapy
EXPERIMENTALInterventions
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. \--------------------------------------------------------------------------------
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Heming Lu, MS
People's Hospital of Guangxi Zhuang Autonomous Region
- PRINCIPAL INVESTIGATOR
Heming Lu, MS
People's Hospital of Guangxi Zhuang Autonomous Region
- PRINCIPAL INVESTIGATOR
Yun Mo, MS
People's Hospital of Guangxi Zhuang Autonomous Region
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 4, 2013
First Posted
September 10, 2013
Study Start
July 1, 2013
Primary Completion
June 1, 2015
Study Completion
June 1, 2016
Last Updated
September 26, 2013
Record last verified: 2013-09