A Multicenter Noninferior Randomized Controlled Study Comparing the Efficacy of Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer (Stage IA1 With LVSI, IA2)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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)

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 21
Maximum Age: 70
Healthy Volunteers: f
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• Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (IA1 with lymphovascular interstitial invasion, stage IA2).

• Age ≥ 21 years and ≤ 70 years.

• Surgery type B and C (refer to Q-M surgical staging)

• 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.

• No history of other malignancies.

• Non-pregnancy.

• Physical strength classification: Karnofsky score ≥ 60;

• Subjects voluntarily joined the study, signed the informed consent form, were compliant and cooperated with the follow-up.

• 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)

Locations
Other Locations
China
The Obstetrics and Gynecology Hospital of Fudan University
RECRUITING
Shanghai
Contact Information
Primary
Hua Jiang, PHD
jianghua@fudan.edu.cn
(021)33189900-6529
Backup
Xin Wu, PHD
wuxin_fc@fudan.edu.cn
(021)33189900-6529
Time Frame
Start Date: 2021-09-24
Estimated Completion Date: 2026-06
Participants
Target number of participants: 690
Treatments
Experimental: 1
the group of LRH
Active_comparator: 2
the group of ARH
Related Therapeutic Areas
Sponsors
Collaborators: Taizhou Hospital, Affiliated Cancer Hospital of the University of Chinese Academy of Sciences, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, First Affiliated Hospital of Wenzhou Medical University, RenJi Hospital, Children's Hospital of Fudan University, Shanghai Zhongshan Hospital
Leads: Hua Jiang

This content was sourced from clinicaltrials.gov