Clinical Study in Post-operation Treatment of Cervical Cancer

March 19, 2012 updated by: Liu Zi, Health Science Center of Xi'an Jiaotong University

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

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).

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

183

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanxi
      • Xi'an, Shanxi, China, 710061
        • Recruiting
        • Xi'an Jiaotong University College of Medicine
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Tao Wang, M.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
radiation therapy only
Including criteria: cervical cancer patients after surgery with big tumor, deep invasion or tumor thrombi in the vascular system, but without lymph invasion, positive surgery margin or parametrium invasion. Patients in this group receive radiation therapy only. radiation therapy regimen: 3D-CRT pelvic radiation, 95%CTV DT 45Gy/25f. Radiation field include tumor bed and regional lymph nodes area. Upper border: branching of abdominal aorta. The radiation fields go down along the iliac vessels (including regions of 7mm out of the iliac vessels) and include the tumor bed region. Lower border: the inferior margin of obturator foramen.
concurrent chemoradiotherapy
Including criteria: cervical cancer patients after surgery with big tumor, deep invasion or tumor thrombi in the vascular system, but without lymph invasion, positive surgery margin or parametrium invasion. Patients in this group receive concurrent chemotherapy and radiation therapy. radiation therapy regimen is the same with radiation therapy only group. Chemotherapy regimen: Topotecan (1.5mg /m2 d1,2, 1mg d3) and Cisplatin (25mg /m2 d1-3). Chemotherapy will be carry out in the 2nd and 6th week of radiation therapy.
concurrent and additional chemotherapy
Including criteria: cervical cancer patients after surgery with big tumor, deep invasion or tumor thrombi in the vascular system, but without lymph invasion, positive surgery margin or parametrium invasion. Patients in this group receive concurrent chemotherapy and radiation therapy, and additional chemotherapy after concurrent treatment. radiation therapy regimen is the same with radiation therapy group. Chemotherapy regimen: Topotecan (1.5mg /m2 d1,2, 1mg d3) and Cisplatin (25mg /m2 d1-3). Chemotherapy will be carry out in the 2nd and 6th week of radiation therapy. Additional chemotherapy regimen is the same with concurrent chemotherapy, and will be carry out in the 4th and 8th week after radiation therapy.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Health Science Center of Xi'an Jiaotong University

Investigators

  • Study Director: Chen M W, M.D, Affiliated Hospital of Medical College of Xo'an Jiaotong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2015

Study Registration Dates

First Submitted

August 16, 2011

First Submitted That Met QC Criteria

August 16, 2011

First Posted (Estimate)

August 17, 2011

Study Record Updates

Last Update Posted (Estimate)

March 21, 2012

Last Update Submitted That Met QC Criteria

March 19, 2012

Last Verified

March 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GCR-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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