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Preoperative Chemoradiotherapy Combined With Nimotuzumab for Cervical Cancer

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2013 by People's Hospital of Guangxi.
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
Wu Jieping Medical Foundation
Information provided by (Responsible Party):
Heming Lu, People's Hospital of Guangxi
ClinicalTrials.gov Identifier:
NCT01938105
First received: September 4, 2013
Last updated: September 24, 2013
Last verified: September 2013
  Purpose
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 Intervention Phase
Locally Advanced Cervical Cancer
Other: Nimotuzumab+chemoradiotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Preoperative Concurrent Chemoradiotherapy Combined With Nimotuzumab Injection for Locally Advanced Cervical Cancer: a Phase II Study

Resource links provided by NLM:


Further study details as provided by People's Hospital of Guangxi:

Primary Outcome Measures:
  • Treatment related toxicities [ Time Frame: at 1 year ] [ Designated as safety issue: Yes ]
    Acute and chronic toxicities.

  • Tumor response after preoperative treatment [ Time Frame: assessed at 4-5 weeks after the completion of preoperative treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: at 1 year ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: at 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: July 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01938105

Locations
China, Guangxi
People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China, 530021
Sponsors and Collaborators
People's Hospital of Guangxi
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
  More Information

Responsible Party: Heming Lu, Associate Professor, People's Hospital of Guangxi
ClinicalTrials.gov Identifier: NCT01938105     History of Changes
Other Study ID Numbers: WJPMF-2013-428-2081 
Study First Received: September 4, 2013
Last Updated: September 24, 2013
Health Authority: China: Ministry of Health

Keywords provided by People's Hospital of Guangxi:
Cervical cancer
Nimotuzumab
Intensity-modulated radiation therapy
Concurrent chemoradiotherapy

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on December 09, 2016