Preoperative Chemoradiotherapy Combined With Nimotuzumab for Cervical Cancer

NCT ID: NCT01938105

Last Updated: 2013-09-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2016-06-30

Brief Summary

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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

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Conditions

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Locally Advanced Cervical Cancer

Keywords

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Cervical cancer Nimotuzumab Intensity-modulated radiation therapy Concurrent chemoradiotherapy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nimotuzumab+chemoradiotherapy

Group Type EXPERIMENTAL

Nimotuzumab+chemoradiotherapy

Intervention Type OTHER

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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Interventions

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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.

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Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wu Jieping Medical Foundation

OTHER

Sponsor Role collaborator

People's Hospital of Guangxi Zhuang Autonomous Region

OTHER

Sponsor Role lead

Responsible Party

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Heming Lu

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heming Lu, MS

Role: STUDY_CHAIR

People's Hospital of Guangxi Zhuang Autonomous Region

Heming Lu, MS

Role: PRINCIPAL_INVESTIGATOR

People's Hospital of Guangxi Zhuang Autonomous Region

Yun Mo, MS

Role: PRINCIPAL_INVESTIGATOR

People's Hospital of Guangxi Zhuang Autonomous Region

Locations

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People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, Guangxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Heming Lu, MS

Role: CONTACT

Phone: +86-771-218-6503

Email: [email protected]

Facility Contacts

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Heming Lu, MS

Role: primary

Other Identifiers

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WJPMF-2013-428-2081

Identifier Type: -

Identifier Source: org_study_id