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

This study is not yet open for participant recruitment.
Verified January 2010 by Huazhong University of Science and Technology
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

February 4, 2010
February 8, 2010
March 2010
January 2014   (final data collection date for primary outcome measure)
The occurrence rate of CTCs, distant metastasis-free survival, disease-free survival, metastatic sites [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01063296 on ClinicalTrials.gov Archive Site
Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
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Effects of Chemotherapy on Circulating Tumor Cells and Recurrences in Cervical Cancer Patients
Effects of Chemotherapy on Circulating Tumor Cells and Recurrences in IB-IIA Cervical Cancer Patients With Intermediate Risk Factors After Radical Surgery

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.

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Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

sampling of peripheral blood

Probability Sample

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

Cervical Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
400
January 2014
January 2014   (final data collection date for primary outcome measure)

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
Female
18 Years to 70 Years
No
Contact: Ma Ding, M.D. 86-27-8362681 dma@tjh.tjmu.edu.cn
China
 
NCT01063296
GM2010-02
Yes
Ding Ma, Cancer Biology Research Center of Tongji Hospital
Huazhong University of Science and Technology
Not Provided
Study Director: Ma Ding, M.D. Tongji Hospital of HUST
Huazhong University of Science and Technology
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP