Effects of Chemotherapy on Circulating Tumor Cells and Recurrences in Cervical Cancer Patients
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Purpose
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.
| Condition |
|---|
|
Cervical Cancer |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Prospective |
| Official Title: | Effects of Chemotherapy on Circulating Tumor Cells and Recurrences in IB-IIA Cervical Cancer Patients With Intermediate Risk Factors After Radical Surgery |
- The occurrence rate of CTCs, distant metastasis-free survival, disease-free survival, metastatic sites [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
- Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]
Biospecimen Retention: Samples With DNA
sampling of peripheral blood
| Estimated Enrollment: | 400 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | January 2014 |
| Estimated Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients with histologically confirmed Ib~IIa cervical carcinoma without previous treatments
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
Contacts and Locations| Contact: Ma Ding, M.D. | 86-27-8362681 | dma@tjh.tjmu.edu.cn |
| China, Hubei | |
| Tongji Hospital of HUST | Not yet recruiting |
| Wuhan, Hubei, China | |
| Contact: Ma Ding, M.D. 86-27-8362681 dma@tjh.tjmu.edu.cn | |
| Study Director: | Ma Ding, M.D. | Tongji Hospital of HUST |
More Information
No publications provided
| Responsible Party: | Ding Ma, Cancer Biology Research Center of Tongji Hospital |
| ClinicalTrials.gov Identifier: | NCT01063296 History of Changes |
| Other Study ID Numbers: | GM2010-02 |
| Study First Received: | February 4, 2010 |
| Last Updated: | February 8, 2010 |
| Health Authority: | China: Ministry of Health |
Keywords provided by Huazhong University of Science and Technology:
|
cervical cancer |
Additional relevant MeSH terms:
|
Uterine Cervical Neoplasms Neoplastic Cells, Circulating Recurrence Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Neoplasms by Site Neoplasms |
Uterine Cervical Diseases Uterine Diseases Genital Diseases, Female Neoplasm Metastasis Neoplastic Processes Pathologic Processes Disease Attributes |
ClinicalTrials.gov processed this record on May 22, 2013