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

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

NCT ID: NCT01063296

Condition: Cervical Cancer

Conditions: Official terms:
Uterine Cervical Neoplasms
Neoplastic Cells, Circulating
Recurrence

Conditions: Keywords:
cervical cancer

Study type: Observational

Overall status: Unknown status

Study design:

Time perspective: Prospective

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.

Criteria for eligibility:

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

Sampling method: Probability Sample
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

Gender: Female

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Tongji Hospital of HUST

Address:
City: Wuhan
Country: China

Contact:
Last name: Ma Ding, M.D.

Phone: 86-27-8362681
Email: dma@tjh.tjmu.edu.cn

Start date: March 2010

Completion date: January 2014

Lead sponsor:
Agency: Huazhong University of Science and Technology
Agency class: Other

Source: Huazhong University of Science and Technology

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT01063296