COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Preoperative Chemoradiotherapy Combined With Nimotuzumab for Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01938105
Recruitment Status : Unknown
Verified September 2013 by Heming Lu, People's Hospital of Guangxi.
Recruitment status was:  Recruiting
First Posted : September 10, 2013
Last Update Posted : September 26, 2013
Wu Jieping Medical Foundation
Information provided by (Responsible Party):
Heming Lu, 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.

Condition or disease Intervention/treatment Phase
Locally Advanced Cervical Cancer Other: Nimotuzumab+chemoradiotherapy Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Concurrent Chemoradiotherapy Combined With Nimotuzumab Injection for Locally Advanced Cervical Cancer: a Phase II Study
Study Start Date : July 2013
Estimated Primary Completion Date : June 2015
Estimated Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cervical Cancer

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.


Primary Outcome Measures :
  1. Treatment related toxicities [ Time Frame: at 1 year ]
    Acute and chronic toxicities.

  2. Tumor response after preoperative treatment [ Time Frame: assessed at 4-5 weeks after the completion of preoperative treatment ]

Secondary Outcome Measures :
  1. Progression-free survival [ Time Frame: at 1 year ]
  2. Overall survival [ Time Frame: at 1 year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01938105

Layout table for location contacts
Contact: Heming Lu, MS +86-771-218-6503

Layout table for location information
China, Guangxi
People's Hospital of Guangxi Zhuang Autonomous Region Recruiting
Nanning, Guangxi, China, 530021
Contact: Heming Lu, MS    +86-771-218-6503   
Principal Investigator: Heming Lu, MS         
Principal Investigator: Yun Mo, MS         
Sponsors and Collaborators
People's Hospital of Guangxi
Wu Jieping Medical Foundation
Layout table for investigator information
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
Layout table for additonal information
Responsible Party: Heming Lu, Associate Professor, People's Hospital of Guangxi Identifier: NCT01938105    
Other Study ID Numbers: WJPMF-2013-428-2081
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: September 26, 2013
Last Verified: September 2013
Keywords provided by Heming Lu, People's Hospital of Guangxi:
Cervical cancer
Intensity-modulated radiation therapy
Concurrent chemoradiotherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Antineoplastic Agents, Immunological
Antineoplastic Agents