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

NCT01063296 | Unknown DMC

• 1 other identifier: GM2010-02
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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

Keywords

cervical cancer

Outcome Measures

Primary Outcomes (1)

• The occurrence rate of CTCs, distant metastasis-free survival, disease-free survival, metastatic sites

  3 years

Secondary Outcomes (1)

• Overall survival

  3 years

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Huazhong University of Science and Technology: lead

Study Sites (1)

Tongji Hospital of HUST

Wuhan, Hubei, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

sampling of peripheral blood

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Ma Ding, M.D.

  Tongji Hospital of HUST

  STUDY DIRECTOR

Central Study Contacts

Ma Ding, M.D.

CONTACT

86-27-8362681; dma@tjh.tjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 4, 2010
• First Posted: February 5, 2010
• Study Start: March 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2014
• Last Updated: February 9, 2010

Record last verified: 2010-01

Locations

CN (1)