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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04934982
Other study ID # FUOBGY2021-03
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 24, 2021
Est. completion date June 2026

Study information

Verified date November 2021
Source Obstetrics & Gynecology Hospital of Fudan University
Contact Hua Jiang, PHD
Phone (021)33189900-6529
Email jianghua@fudan.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to confirm whether there is a difference between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) in patient survival for Cervical Cancer (Stage IA1 with LVSI, IA2)


Description:

The purpose of this study is to compare LRH (or robotic-assisted) and ARH in patients with cervical cancer (Stage IA1 with LVSI, IA2), by a multicenter stratified randomized controlled study, mainly including the following aspects: 1. To compare the differences in PFS and OS between patients receiving LRH and ARH. 2. To investigate whether PFS and OS in LRH can be improved by more rigorous specification of surgical details (including tumor-free principles and standard surgical scopes). 3. To assess postoperative complications and quality of survival.


Recruitment information / eligibility

Status Recruiting
Enrollment 690
Est. completion date June 2026
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender Female
Age group 21 Years to 70 Years
Eligibility Inclusion Criteria: 1. Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (IA1 with lymphovascular interstitial invasion, stage IA2). 2. Age = 21 years and = 70 years. 3. Surgery type B and C (refer to Q-M surgical staging) 4. Normal range of liver and kidney function and blood count (specific details below) Hemoglobin > 60g/L Platelets > 70*109/L Leukocytes > 3*109/L Creatinine < 50mg/dL Transaminase abnormal indicators = 3 Maximum value of transaminases not exceeding 3 times the corresponding normal value. 5. No history of other malignancies. 6. Non-pregnancy. 7. Physical strength classification: Karnofsky score = 60; 8. Subjects voluntarily joined the study, signed the informed consent form, were compliant and cooperated with the follow-up. 9. No psychiatric disorders and other serious immune system disorders (e.g. lupus erythematosus, myasthenia gravis, HIV infection, etc.) (Note: Maximum diameter measurement of cervical lesions is based on PET-CT, or CT, or MRI) Exclusion Criteria: 1. Those who are contraindicated for various surgeries and cannot undergo surgery. 2. Patients who have received pelvic/abdominal radiotherapy irradiation or neoadjuvant chemotherapy for cervical cancer. 3. Patients with recurrent cervical cancer 4. Patients with CT, MRI or PET-CT suggesting suspicious metastasis of pelvic lymph nodes with maximum diameter >2cm after further improvement of preoperative examination.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Total Laparoscopic or Robotic Radical Hysterectomy
Stage IA1 with lymphovascular interstitial infiltration and IA2 surgical approach was type B (modified radical hysterectomy plus bilateral pelvic lymph node dissection, i.e., resection of 1~2 cm of the parametrium and 1~2 cm of the vagina) with abdominal para-aortic lymph node dissection if necessary (surgical staging according to FIGO 2018 and surgical staging according to Querleu-Morrow staging).
Total Abdominal Radical Hysterectomy
Stage IA1 with lymphovascular interstitial infiltration and IA2 surgical approach was type B (modified radical hysterectomy plus bilateral pelvic lymph node dissection, i.e., resection of 1~2 cm of the parametrium and 1~2 cm of the vagina) with abdominal para-aortic lymph node dissection if necessary (surgical staging according to FIGO 2018 and surgical staging according to Querleu-Morrow staging).

Locations

Country Name City State
China The Obstetrics and Gynecology Hospital of Fudan University Shanghai

Sponsors (7)

Lead Sponsor Collaborator
Hua Jiang Children's Hospital of Fudan University, First Affiliated Hospital of Wenzhou Medical University, RenJi Hospital, Shanghai Zhongshan Hospital, Taizhou Hospital, Affiliated Cancer Hospital of the University of Chinese Academy of Sciences, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Other Analysis of continuous outcomes Compare these between groups(The continuous outcomes include operative duration(min), anesthesia time(min), blood loss during operation(ml), postoperative pain score and postoperative hospital stay(day). The outcomes with normal distribution will be summarised using mean and standard deviation (SD), while the outcomes with non-normal distribution will be summarised using median and interquartile. The differences in the outcomes and 95% CIs will be analysed by generalised linear model (GLM) with treatment as fixed effect and with normal distribution and identity link function.) 1 years from surgery
Other Analysis of binary outcomes Compare these between groups(The intraoperative complications, postoperative complications, one-month and one-year postoperative quality of life and sexual life will be treated as binary outcomes and will be summarised by number (%) of participants with the event. The differences in the outcomes and 95% CIs will be analysed by GLM with treatment as fixed effect and with binomial distribution and identity link function.) 5 years from surgery
Other Safety analysis Adverse events (AEs) will be summarised using the number of AEs, the number (%) of participants with AEs by groups. 5 years from surgery
Primary the rate of PFS at 5 years The curves of PFS at 5 years will be estimated using the Kaplan-Meier method. The logrank test will be used to test the above hypothesis, the 5-year PFS rate difference and its 95% confidence interval (CI) for the comparison between the two groups will be estimated. 5 years from surgery
Secondary the rate of OS at 5 years Compare between groups(Cox proportional hazards model will be used to estimate the hazard ratio and 95% CI for the effect of treatment on the 5-year OS rate.) 5 years from surgery
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