Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IA1 With LVSI, IA2)

Cervical Cancer Clinical Trial

— LAUNCH 1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04934982
• Other study ID #: FUOBGY2021-03
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cervical Cancer
• Uterine Cervical Neoplasms

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