Cervical cancer
Conditions
Interventions
Adjuvant chemotherapy group:Platinum-based chemotherapy
Control group:No Intervention
Sponsors
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
Female
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.Patients with 2018 FIGO staged IB1, IB2, IIA1 cervical cancer. 2.The initial treatment was radical hysterectomy + pelvic lymphadenectomy by laparotomy or laparoscopy with cervical cancer foci sealed before dissection of the vagina and without uterine manipulator. 3.Postoperative pathological diagnosis was cervical squamous cell carcinoma, cervical adenosquamous cell carcinoma or cervical adenocarcinoma. 4.Assessment of risk factors not meeting Sedlis criteria (NCCN guideline) but having one of following factors: (1) Deep stromal infiltration (>= 2/3 layer); (2) Histopathological differentiation grade G2 ~ G3; (3) Lymph-vascular space invasion; (4) Adenocarcinoma or adenosquamous cell carcinoma; (5) Tumor size >= 2cm. 5.Aged 18-70 years. 6.WBC >= 3.5*10^9/L, NEU >= 1.5*10^9/L, Platelet >= 80 x 10^9 /L; AST and ALT <= 1.5 times normal upper limit; Total bilirubin <= 1.5 times the upper limit of normal value; serum creatinine and blood urea nitrogen <= the upper limit of normal value. 7.Eastern Cooperative Oncology Group score 0-1. 8.Well-compliance and willing to keep in touch. 9.Willing to participate in this study, and sign the informed consent.1.
Exclusion criteria
Exclusion criteria: 1.Postoperative pathology has high-risk factors (lymph node metastasis, parametrial infiltration or positive surgical margin) or meets Sedlis criteria. 2.Participate in other clinical trials at the same time. 3.Comorbidity including but not limited to: heart diseases (grade III-IV cardiac insufficiency (NYHA standard); central nervous system diseases or nonfunctional behavior; hematological system diseases; liver or kidney malformation or history of surgery. 4.Drug and/or alcohol abuse. 5.Not eligible for the study judged by researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 3 year DFS; | — |
Secondary
| Measure | Time frame |
|---|---|
| 3 year OS;5 year DFS and OS;Incidence of adverse event;Quality of life; | — |
Countries
China
Contacts
Public ContactDing Ma
Tongji Hospital, Tongji Medical College, HUST
Outcome results
None listed