Cervical Cancer Clinical Trial
Official title:
Comparison of Different Adjuvant Treatments Following Radical Surgery in Early Stage Cervical Carcinoma
Cervical cancer is still the most common gynecologic cancer. There was no obvious increase of
the survival over years. The risk of recurrence after radical surgery has increased with
positive lymph nodes, positive surgical margins, positive lymphatic vascular space and deep
invasion of the cervical stroma. In recent years, the role of chemotherapy for cervical
cancer has been gradually recognized. But as a adjuvant therapy post-surgery, if chemotherapy
can improve the overall survival rate of patients with adverse pathological prognostic
factors is inconclusive.
In this study, in order to investigate the effect and adverse reaction of chemotherapy as the
adjuvant therapy post-surgery on patients with adverse pathological prognostic factors, nine
hundred and ninety patients will be randomly divided into three groups, comparing
radiotherapy alone, concurrent chemoradiation and sequence chemotherapy and radiotherapy (2
cycles chemotherapy of Paclitaxel and Cisplatin before and after the irradiation). The
investigators aim to find out the best therapeutic regimen with lowest adverse reaction for
cervical cancer with adverse pathological prognostic factors. To guide clinical treatment
options.
After radical surgery, patients with stage IB1 to IIA2 cervical cancer who had one or more
following pathological factors were recruited: lymph node metastases (LNM), positive
parametrium or margins (PPM), lymphatic vascular space involvement (LVSI), deep invasion of
cervical stromal (DIS). Eligible patients were randomized to three groups. Group A underwent
50 GY RT alone. Group B received concurrent weekly cisplatin and RT. Group C received
paclitaxel and bolus cisplatin every three weeks for two cycles before RT, followed by two
cycles.
We have recruited 800 patients till November 2014.
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