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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01418859
Other study ID # GCR-01
Secondary ID
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


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, 

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