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

NCT ID: NCT01063296

Last Updated: 2010-02-09

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 400 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-03-31
• Study Completion Date: 2014-01-31

Brief 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.

Conditions

Cervical Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Huazhong University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Cancer Biology Research Center of Tongji Hospital

Principal Investigators

Ma Ding, M.D.

Role: STUDY_DIRECTOR

Tongji Hospital of HUST

Locations

Tongji Hospital of HUST

Wuhan, Hubei, China

Countries

China

Central Contacts

Ma Ding, M.D.

Role: CONTACT

dma@tjh.tjmu.edu.cn

86-27-8362681

Facility Contacts

Ma Ding, M.D.

Role: primary

dma@tjh.tjmu.edu.cn

86-27-8362681

Other Identifiers

GM2010-02

Identifier Type: -

Identifier Source: org_study_id