Clinical Study in Post-operation Treatment of Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

Status and the Application of Topotecan at Post-operation Treatment of Cervical Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01418859
• Other study ID #: GCR-01
• Status: Recruiting
• Phase: N/A
• First received: August 16, 2011
• Last updated: March 19, 2012
• Start date: August 2011
• Est. completion date: December 2015

Study information

• Verified date: March 2012
• Source: Xi’an Jiaotong University College of Medicine
• Contact: Liu Zi, M.D
• Phone: 86-18991232167
• Email: liuzmail[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial Summary

The purpose of the research is to evaluate the effect of additional chemotherapy in postoperation therapy of cervical cancer patients with risk factors (big tumor, deep invasion or tumor thrombi in the vascular system).

Description:

Cervical cancer has a very high morbidity. Many patients need additional therapy after surgery in order to elevate the survival rate and life quality. In this research, we are going to give additional therapy to patients who have big tumor, deep invasion or tumor thrombi in the vascular system after surgery. randomized control method will be used in this research, in order to compare the survival rate and side effects between radiation therapy only, concurrent chemoradiotherapy, and concurrent chemoradiotherapy with additional chemotherapy. 3D-CRT and Topotecan will be used in this research.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 183
• Est. completion date: December 2015
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 70 Years

Eligibility

Inclusion Criteria:

1. patients who underwent the cervical cancer radical surgery in three months have higt risk factors which including deep stromal invasion,large primary tumour and/or lymphovascular spase invasion;

2. squamous carcinoma;

3. age<70;

4. Gynecologic Oncology Group (GOG):0-2.

Exclusion Criteria:

1. negative nodes,surgical margin,and/or parametrium;

2. No serious damage to the liver and kidney function, no hypertension,diabetes and other effects of therapy complications.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
China	Xi'an Jiaotong University College of Medicine	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xi’an Jiaotong University College of Medicine

Country where clinical trial is conducted

China,