Preoperative Chemoradiotherapy Combined With Nimotuzumab for Cervical Cancer

Phase 2

• Conditions: Locally Advanced Cervical Cancer

• 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

Study Timeline

• Study Start: 2013-07
• Status Verified: 2013-09
• Study First Submitted: 2013-09-04
• Study First Submitted QC: 2013-09-04
• Study First Posted: 2013-09-10
• Last Update Submitted: 2013-09-24
• Last Update Posted: 2013-09-26
• Primary Completion: 2015-06
• Study Completion: 2016-06

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

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