A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients
A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients
We will conduct a trial to determine whether paclitaxel/cisplatin (TP) as an adjuvant
 chemotherapy after radical surgery improve disease-free survival (DFS) and overall survival
 (OS), as well as the quality of life (QoL) among early-stage (FIGO stage IB-IIA) cervical
 cancer patients with risk factors.
Inclusion Criteria:

 -  FIGO stage: ⅠB～ⅡA, cervical cancer;

 -  Age≤60 years; female, Chinese women;

 -  Initial treatment is radical hysterectomy + pelvic lymph node dissection;

 -  Pathological diagnosis: cervical squamous cell invasive carcinoma;

 -  Pathologic examination and meet the following one of the indications of adjuvant
 therapy: ① lymph node metastasis, ② parametrial invasion, ③ ≥ 2/3 deep stromal
 invasion, ④ histopathological grading in poorly differentiated (G2 to G3), ⑤ lymphatic
 vascular space involvement, ⑥ tumor diameter> 4cm;

 -  Laboratory tests: WBC≥4×10(9)/L, NEU≥2×10(9)/L, PLT≥80×10(9)/L, serum bilirubin≤ 1.5
 times the upper limit of normal, transaminase≤ 1.5 times the upper limit of normal,
 BUN, Cr≤ normal

 -  Performance status: Karnofsky score≥60;

 -  No prior treatment;

 -  Receiving extensive resection of uterus (type III) plus pelvic lymph nodes wide
 resection; pathologically diagnosed with cervical squamous cell carcinoma;

 -  Provide written informed consent.

 Exclusion Criteria:

 -  With severe or uncontrolled internal disease, unable to receive surgery and/or
 unsuitable for radiotherapy or chemotherapy

 -  History of organ transplantation, immune diseases;

 -  History of serious mental illness, a history of brain dysfunction;

 -  Drug abuse or a history of drug abuse;

 -  Suffering from other malignancies;

 -  Concurrently participating in other clinical trials

 -  Unable or unwilling to sign informed consents;

 -  Unable or unwilling to abide by protocol.