Cervical Cancer, Uterine Cervical Neoplasms
Conditions
Brief summary
This is a prospective, phase 3 randomized controlled clinical trial. Cervical cancer patients who undergo radical surgery but do not meet criteria of adjuvant therapy according to NCCN guideline are enrolled to receive adjuvant chemotherapy. The primary endpoint was disease-free survival (DFS) rate at 3 year. The secondary endpoints were 5-year DFS, overall survival (OS) and safety.
Interventions
DRUGPaclitaxel or docetaxel + Cisplatin or carboplatin
Paclitaxel 135-175mg/m2 over 3 hours or docetaxel 70-75 mg/m2， 30min ＋ Cisplatin 75-80mg/m2 or carboplatin AUC = 5, repeat per 21 days.
Sponsors
Women's Hospital School Of Medicine Zhejiang University
Qilu Hospital of Shandong University
Obstetrics & Gynecology Hospital of Fudan University
First Affiliated Hospital of Chongqing Medical University
Hunan Cancer Hospital
The Third Xiangya Hospital of Central South University
Huazhong University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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. Age：18-70 years old. 6. WBC≥3.5\*10\^9/L, NEU≥1.5\*10\^9/L, Platelet≥80×10\^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.
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. Persons without disposing capacity. 5. Drug and/or alcohol abuse. 6. Unable or unwilling to sign informed consents. 7. Not eligible for the study judged by researchers.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease-free survival (DFS) | 3 year | DFS is defined as the time interval between the date of random assignment and the date of the first documented evidence of relapse at any site or death related to cancer (including toxicity), whichever occurred first. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival （OS） | 3 year | OS is defined as the time from the date of randomization until death of any cause. |
| 5-year DFS/OS | 5 years | DFS is defined as the time interval between the date of random assignment and the date of the first documented evidence of relapse at any site or death related to cancer (including toxicity), whichever occurred first. OS is defined as the time from the date of randomization until death of any cause. |
| Incidence of Toxicity | 2 years | The toxicity induced by chemotherapy during observation time will be estimated on the basis of the National Cancer Institute Common Toxicity Criteria Version 5.0. |
Countries
China
Outcome results
None listed