Clinical Study in Post-operation Treatment of Cervical Cancer

• Conditions: Cervical Cancer

• Registration Number: NCT01418859
• Lead Sponsor: Health Science Center of Xi'an Jiaotong University

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-16
• Study First Submitted QC: 2011-08-16
• Study First Posted: 2011-08-17
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-19
• Last Update Posted: 2012-03-21
• Primary Completion: 2012-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 183

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Xi'an Jiaotong University College of Medicine; 🇨🇳 Xi'an, Shanxi, China