A Multicenter, Prospective, Randomized Trial of Adjuvant Chemotherapy for Early-Stage Cervical Cancer Patients
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.