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RecruitingNCT04929769LAUNCH 2Updated Nov 1, 2021

Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB1,IB2,IIA1)

An interventional study of Total Laparoscopic or Robotic Radical Hysterectomy and Total Abdominal Radical Hysterectomy in Cervical Cancer, sponsored by Obstetrics & Gynecology Hospital of Fudan University. Recruiting at 1 site in China. Open to female participants aged 21 Years to 70 Years. Per ClinicalTrials.gov, last updated 2021-11-01.

Sponsored by Obstetrics & Gynecology Hospital of Fudan University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Sep 2024, 2 years 1 month ago, but the record still lists the study as recruiting.
  • Started May 2021; still recruiting 5 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
780
Allocation
Randomized
Ages
21 Years to 70 Years
Sex
Female
01

Study 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 IB1, IB2, IIA1).

Read the detailed description

The purpose of this study is to compare LRH (or robotic-assisted) and ARH in patients with cervical cancer (Stage IB1, IB2, IIA1), 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.
02

Conditions studied

  • Cervical Cancer

Keywords

  • Cervical Cancer
  • Abdominal Radical Hysterectomy
  • Laparoscopic Radical Hysterectomy
03

In context

Uterine Cervical Neoplasms

1,881 studies on the registry are indexed under Uterine Cervical Neoplasms; 567 are open to participants now.

This study's planned enrollment of 780 is above the median of 100 across 1,377 interventional studies indexed under Uterine Cervical Neoplasms.

Browse Uterine Cervical Neoplasms studies →

Lead sponsor

Obstetrics & Gynecology Hospital of Fudan University is the lead sponsor of 24 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  1. Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (Stage IB1,IB2,IIA1).
  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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
780 participants (estimated)

Study arms

  • Experimental
    1

    the group of LRH

    Other: Total Laparoscopic or Robotic Radical Hysterectomy

  • Active comparator
    2

    the group of ARH

    Other: Total Abdominal Radical Hysterectomy

Interventions

  • OtherTotal Laparoscopic or Robotic Radical Hysterectomy

    Radical hysterectomy with bilateral pelvic lymph node dissection is performed as standard type C RH by Q-M classification, including cardinal ligaments divided at pelvic sidewall and uterosacral ligaments divided at near the sacral origin and the upper 1/4 to 1/3 of the vagina.

  • OtherTotal Abdominal Radical Hysterectomy

    Radical hysterectomy with bilateral pelvic lymph node dissection is performed as standard type C RH by Q-M classification, including cardinal ligaments divided at pelvic sidewall and uterosacral ligaments divided at near the sacral origin and the upper 1/4 to 1/3 of the vagina.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 5 years from surgery

Secondary outcomes

  1. the rate of OS at 5 years

    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.

    Time frame: 5 years from surgery

Other outcomes

  1. Analysis of continuous outcomes

    Compare these between groups(The continuous outcomes include operative duration, anesthesia time, blood loss during operation, postoperative pain score and postoperative hospital stay.)

    Time frame: 1 years from surgery

  2. 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.)

    Time frame: 5 years from surgery

  3. Safety analysis

    Adverse events (AEs) will be summarised using the number of AEs, the number (%) of participants with AEs by groups.

    Time frame: 5 years from surgery

07

Study locations

1 of 1 sites recruiting
  • The Obstetrics and Gynecology Hospital of Fudan University
    Shanghai, Shanghai 200000, China
    Recruiting
08

References and documents

Publications

  • Wu X, Qiu L, Lou W, Wang X, Zhu T, Zhang Y, Hu W, Xue X, Zhu Z, Xiang L, Li J, Fang X, Gao S, Feng H, Diao W, Zhang H, Du M, Bai Y, Hou Y, Yan W, Feng H, Yu H, Zhu S, Du Y, Jiang H. A multicenter non-inferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stages IB1, IB2, and IIA1): study protocol of the LAUNCH 2 trial. Trials. 2022 Apr 8;23(1):269. doi: 10.1186/s13063-022-06245-5. PubMed 35395868 ↗

Study documents

  • Protocol and statistical analysis plan · Dec 21, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04929769
Lead sponsor
Obstetrics & Gynecology Hospital of Fudan University
Collaborators
Children's Hospital of Fudan University, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai Zhongshan Hospital, RenJi Hospital, Taizhou Hospital, Affiliated Cancer Hospital of the University of Chinese Academy of Sciences, First Affiliated Hospital of Wenzhou Medical University
Responsible party
Sponsor
First posted
Jun 18, 2021
Start date
May 7, 2021
Primary completion
Sep 7, 2024 (estimated)
Completion
Sep 7, 2026 (estimated)
Last update
Nov 1, 2021

Study contacts

Xin Wu, PHD
Contact
wuxin_fc@fudan.edu.cn
(021)33189900-6529
Jiang Hua, PHD
Contact
jianghua@fudan.edu.cn
(021)33189900-6529
Xin Wu, PHD
principal investigator · The Obstetrics and Gynecology Hospital of Fudan University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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