Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IA1 With LVSI, IA2) (LAUNCH 1)

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

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)

Study Overview

• Status: Recruiting
• Conditions: Cervical Cancer
• Intervention / Treatment: Other: Total Laparoscopic or Robotic Radical Hysterectomy; Other: Total Abdominal Radical Hysterectomy

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 690
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 20000
    • Recruiting
    • The Obstetrics and Gynecology Hospital of Fudan University
    • Contact: Hua Jiang, PHD
    • Contact: Phone Number: (86)13601978182; Email: jianghua@fudan.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; the group of LRH	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).
Active Comparator: 2; the group of ARH	Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Wu X, Feng H, Gao S, Feng H, Diao W, Zhang H, Du M, Lou W, Wang X, Zhu T, Zhang Y, Hu W, Xue X, Zhu Z, Xiang L, Li J, Fang X, Bai Y, Hou Y, Yan W, Qiu L, Yu H, Zhu S, Du Y, Jiang H. A multicenter noninferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stage IA1 with LVSI, IA2): study protocol of the LAUNCH 1 trial. BMC Cancer. 2022 Apr 9;22(1):384. doi: 10.1186/s12885-022-09494-4.

Study record dates

Study Major Dates

• Study Start (Actual): September 24, 2021
• Primary Completion (Anticipated): June 1, 2024
• Study Completion (Anticipated): June 1, 2026

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 14, 2021
• First Posted (Actual): June 22, 2021

Study Record Updates

• Last Update Posted (Actual): November 10, 2021
• Last Update Submitted That Met QC Criteria: November 2, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Cervical Cancer; Abdominal Radical Hysterectomy; Laparoscopic Radical Hysterectomy
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Cervical Diseases; Uterine Diseases; Uterine Cervical Neoplasms
• Other Study ID Numbers: FUOBGY2021-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No