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Clinical Study in Post-operation Treatment of Cervical Cancer

This study is currently recruiting participants.
Verified March 2012 by Xi’an Jiaotong University College of Medicine
Sponsor:
Information provided by (Responsible Party):
Liu Zi, Xi'an Jiaotong University College of Medicine
ClinicalTrials.gov Identifier:
NCT01418859
First received: August 16, 2011
Last updated: March 19, 2012
Last verified: March 2012
History of Changes
  Purpose

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).


Condition
Cervical Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Status and the Application of Topotecan at Post-operation Treatment of Cervical Cancer

Resource links provided by NLM:

Drug Information available for: Topotecan
U.S. FDA Resources

Further study details as provided by Xi’an Jiaotong University College of Medicine:

Estimated Enrollment: 183
Study Start Date: August 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01418859

Contacts
Contact: Liu Zi, M.D 86-18991232167 liuzmail@163.com
Contact: Wang Tao, M.D 86-18991232386 taowangmd@163.com

Locations
China, Shanxi
Xi'an Jiaotong University College of Medicine Recruiting
Xi'an, Shanxi, China, 710061
Contact: Zi Liu, M.D     086-18991232167     18991232167@189.cn    
Contact: Tao Wang, M.D     086-18991232386     18991232386@189.cn    
Sub-Investigator: Tao Wang, M.D            
Sponsors and Collaborators
Xi’an Jiaotong University College of Medicine
Investigators
Study Director: Chen M W, M.D Affiliated Hospital of Medical College of Xo'an Jiaotong University
  More Information

No publications provided

Responsible Party: Liu Zi, Profesor, Xi'an Jiaotong University College of Medicine
ClinicalTrials.gov Identifier: NCT01418859     History of Changes
Other Study ID Numbers: GCR-01
Study First Received: August 16, 2011
Last Updated: March 19, 2012
Health Authority: China: Ministry of Health

Keywords provided by Xi’an Jiaotong University College of Medicine:
cervical cancer
postoperation
chemotherapy
radiotherapy

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 22, 2013