Preoperative Chemoradiotherapy Combined With Nimotuzumab for Cervical Cancer

Locally Advanced Cervical Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01938105
• Other study ID #: WJPMF-2013-428-2081
• Status: Recruiting
• Phase: Phase 2
• First received: September 4, 2013
• Last updated: September 24, 2013
• Start date: July 2013
• Est. completion date: June 2016

Study information

• Verified date: September 2013
• Source: People's Hospital of Guangxi
• Contact: Heming Lu, MS
• Phone: +86-771-218-6503
• Email: gxheminglu[@]sina.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Locally Advanced Cervical Cancer
• Uterine Cervical Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	People's Hospital of Guangxi Zhuang Autonomous Region	Nanning	Guangxi

Sponsors (2)

Lead Sponsor	Collaborator
People's Hospital of Guangxi	Wu Jieping Medical Foundation

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment related toxicities	Acute and chronic toxicities.	at 1 year	Yes
Primary	Tumor response after preoperative treatment		assessed at 4-5 weeks after the completion of preoperative treatment	No
Secondary	Progression-free survival		at 1 year	No
Secondary	Overall survival		at 1 year	No