Comparison of Different Subsequent Treatments After Radical Surgery
Comparison of Different Subsequent Treatments After Radical Surgery
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.
Inclusion Criteria:

 -  Patients with newly histologically confirmed cervical carcinoma

 -  Original clinical stage must be Ib~IIa （FIGO）

 -  Age between 18-65

 -  With the presence of these four factors after radical surgery:(1)positive lymph
 nodes,(2)positive parametria, or positive surgical margins,(3)positive lymphatic
 vascular space,(4)outer one-third invasion of the cervical stroma

 -  More than 3 months survival is to expect

 -  Patients must give signed informed consent

 Exclusion Criteria:

 -  The presence of uncontrolled life-threatening illness

 -  Receiving other ways of anti-cancer therapy

 -  Residual tumor which can not be removed in the surgery

 -  Investigator consider the patients can't finish the whole study

 -  With normal liver function test (ALT、AST>2.5×ULN)

 -  With normal renal function test (Creatinine>1.5×ULN)

 -  WBC<4,000/mm3 or PLT<100,000/mm3

 -  Receive the external pelvic irradiation before the surgery