Effects of Chemotherapy on Circulating Tumor Cells and Recurrences in Cervical Cancer Patients
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|ClinicalTrials.gov Identifier: NCT01063296|
Recruitment Status : Unknown
Verified January 2010 by Huazhong University of Science and Technology.
Recruitment status was: Not yet recruiting
First Posted : February 5, 2010
Last Update Posted : February 9, 2010
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 or disease|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Effects of Chemotherapy on Circulating Tumor Cells and Recurrences in IB-IIA Cervical Cancer Patients With Intermediate Risk Factors After Radical Surgery|
|Study Start Date :||March 2010|
|Estimated Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||January 2014|
- The occurrence rate of CTCs, distant metastasis-free survival, disease-free survival, metastatic sites [ Time Frame: 3 years ]
- Overall survival [ Time Frame: 3 years ]
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01063296
|Contact: Ma Ding, M.D.||firstname.lastname@example.org|
|Tongji Hospital of HUST||Not yet recruiting|
|Wuhan, Hubei, China|
|Contact: Ma Ding, M.D. 86-27-8362681 email@example.com|
|Study Director:||Ma Ding, M.D.||Tongji Hospital of HUST|