Preoperative Chemoradiotherapy Combined With Nimotuzumab for Cervical Cancer
Phase 2
- Conditions
- Locally Advanced Cervical Cancer
- Interventions
- Other: Nimotuzumab+chemoradiotherapy
- Registration Number
- NCT01938105
- Lead Sponsor
- People's Hospital of Guangxi
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 40
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Nimotuzumab+chemoradiotherapy Nimotuzumab+chemoradiotherapy -
- Primary Outcome Measures
Name Time Method Treatment related toxicities at 1 year Acute and chronic toxicities.
Tumor response after preoperative treatment assessed at 4-5 weeks after the completion of preoperative treatment
- Secondary Outcome Measures
Name Time Method Overall survival at 1 year Progression-free survival at 1 year
Trial Locations
- Locations (1)
People's Hospital of Guangxi Zhuang Autonomous Region
🇨🇳Nanning, Guangxi, China