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

Cervical Cancer Clinical Trial

Official title:

Effects of Chemotherapy on Circulating Tumor Cells and Recurrences in IB-IIA Cervical Cancer Patients With Intermediate Risk Factors After Radical Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01063296
• Other study ID #: GM2010-02
• Status: Not yet recruiting
• Phase: N/A
• First received: February 4, 2010
• Last updated: February 8, 2010
• Start date: March 2010
• Est. completion date: January 2014

Study information

• Verified date: January 2010
• Source: Huazhong University of Science and Technology
• Contact: Ma Ding, M.D.
• Phone: 86-27-8362681
• Email: dma[@]tjh.tjmu.edu.cn
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cervical Cancer
• Neoplastic Cells, Circulating
• Uterine Cervical Neoplasms

Locations

Country	Name	City	State
China	Tongji Hospital of HUST	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Huazhong University of Science and Technology

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The occurrence rate of CTCs, distant metastasis-free survival, disease-free survival, metastatic sites		3 years	Yes
Secondary	Overall survival		3 years	Yes