Preoperative Chemoradiotherapy Combined With Nimotuzumab for Cervical Cancer

September 24, 2013 updated by: Heming Lu, People's Hospital of Guangxi

Preoperative Concurrent Chemoradiotherapy Combined With Nimotuzumab Injection for Locally Advanced Cervical Cancer: a Phase II Study

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangxi
      • Nanning, Guangxi, China, 530021
        • Recruiting
        • People's Hospital of Guangxi Zhuang Autonomous Region
        • Contact:
        • Principal Investigator:
          • Heming Lu, MS
        • Principal Investigator:
          • Yun Mo, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Other: 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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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

This is where you will find people and organizations involved with this study.

Sponsor

People's Hospital of Guangxi

Collaborators

Wu Jieping Medical Foundation

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (Anticipated)

June 1, 2015

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

September 4, 2013

First Submitted That Met QC Criteria

September 4, 2013

First Posted (Estimate)

September 10, 2013

Study Record Updates

Last Update Posted (Estimate)

September 26, 2013

Last Update Submitted That Met QC Criteria

September 24, 2013

Last Verified

September 1, 2013

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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