Effects of Chemotherapy on Circulating Tumor Cells and Recurrences in Cervical Cancer Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Huazhong University of Science and Technology.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Huazhong University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01063296
First received: February 4, 2010
Last updated: February 8, 2010
Last verified: January 2010
  Purpose

Cervical cancer is a major health problem for Chinese women. It is estimated that nearly 100,000 new cervical cancer cases occur in China every year, which accounts for about 20 percent of global new cases. Surgery and radiotherapy are two major radical treatment methods for IB-IIB cervical cancer. Unlike the United States and some other countries, most of operable women with IB-IIB cervical cancer received radical surgery other than radiotherapy in China. Patients with recurrence risk factors (lymph node metastasis, deep stromal invasion, positive lymphatic vascular space, et al. ) also received adjuvant therapy after surgery, such as radiotherapy or chemoradiotherapy that are recommended in the NCCN guidelines. However, in China a substantial part of patients especially those admitted to tertiary hospitals received several courses of chemotherapy instead of radiotherapy if they had recurrence risk factors .

In our previous study, we found that patients with intermediate risk factors (deep stromal invasion, positive lymphatic vascular space, bulky tumor>4cm) had better disease-free survival and recurrence-free survival when they received chemotherapy compared with radiotherapy. The objective in this study is to investigate whether the advantage of postoperative chemotherapy is a result of circulating tumor cells (CTC) in some of the patients with intermediate risk factors.


Condition
Cervical Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Effects of Chemotherapy on Circulating Tumor Cells and Recurrences in IB-IIA Cervical Cancer Patients With Intermediate Risk Factors After Radical Surgery

Resource links provided by NLM:


Further study details as provided by Huazhong University of Science and Technology:

Primary Outcome Measures:
  • The occurrence rate of CTCs, distant metastasis-free survival, disease-free survival, metastatic sites [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

sampling of peripheral blood


Estimated Enrollment: 400
Study Start Date: March 2010
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with histologically confirmed Ib~IIa cervical carcinoma without previous treatments

Criteria

Inclusion Criteria:

  • Patients with histologically confirmed Ib~IIa (FIGO)cervical carcinoma without previous treatments
  • Age between 18-70
  • With the presence of these three pathological risk factors after radical surgery:(1) positive lymphatic vascular space,(2)outer one-third invasion of the cervical stroma, (3) bulky tumor≥4cm
  • At least 3 months of disease-free survival

Exclusion Criteria:

  • The presence of other uncontrolled life-threatening disease (Suffering from myocardial infarction or stroke, or unstable angina, decompensated heart failure, or a history of deep vein thrombosis)
  • Receiving other anti-cancer therapy, such as traditional Chinese drug
  • Don't be able to finish the whole treatment(chemotherapy or radiotherapy)
  • liver dysfunction (ALT、AST>2.5×ULN)
  • renal dysfunction (Creatinine>1.5×ULN)
  • WBC<4,000/mm3 or PLT<100,000/mm3
  • Received preoperative radiotherapy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01063296

Contacts
Contact: Ma Ding, M.D. 86-27-8362681 dma@tjh.tjmu.edu.cn

Locations
China, Hubei
Tongji Hospital of HUST Not yet recruiting
Wuhan, Hubei, China
Contact: Ma Ding, M.D.    86-27-8362681    dma@tjh.tjmu.edu.cn   
Sponsors and Collaborators
Huazhong University of Science and Technology
Investigators
Study Director: Ma Ding, M.D. Tongji Hospital of HUST
  More Information

No publications provided

Responsible Party: Ding Ma, Cancer Biology Research Center of Tongji Hospital
ClinicalTrials.gov Identifier: NCT01063296     History of Changes
Other Study ID Numbers: GM2010-02
Study First Received: February 4, 2010
Last Updated: February 8, 2010
Health Authority: China: Ministry of Health

Keywords provided by Huazhong University of Science and Technology:
cervical cancer

Additional relevant MeSH terms:
Uterine Cervical Neoplasms
Recurrence
Neoplastic Cells, Circulating
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Disease Attributes
Pathologic Processes
Neoplasm Metastasis
Neoplastic Processes

ClinicalTrials.gov processed this record on September 22, 2014