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NCT Number: NCT04929769

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

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).

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Key information

Age range

21 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Obstetrics and Gynecology Hospital of Fudan University

Shanghai, Shanghai Municipality, 200000, China

Location status: Recruiting

Location contact

Xin Wu, PHD

CONTACT

[email protected]

8613764046908

About this study

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:

  • To compare the differences in PFS and OS between patients receiving LRH and ARH.
  • 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).
  • To assess postoperative complications and quality of survival.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Those who are contraindicated for various surgeries and cannot undergo surgery.
  • Patients who have received pelvic/abdominal radiotherapy irradiation or neoadjuvant chemotherapy for cervical cancer.
  • Patients with recurrent cervical cancer
  • Patients with CT, MRI or PET-CT suggesting suspicious metastasis of pelvic lymph nodes with maximum diameter >2cm after further improvement of preoperative examination.

Treatment and study plan

Total Laparoscopic or Robotic Radical Hysterectomy

Other

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.

Total Abdominal Radical Hysterectomy

Other

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.

Primary outcomes

  1. the rate of PFS at 5 years

    Time frame: 5 years from surgery

    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.

Secondary outcomes

  1. the rate of OS at 5 years

    Time frame: 5 years from surgery

    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.

Other outcomes

  1. Analysis of continuous outcomes

    Time frame: 1 years from surgery

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

  2. Analysis of binary outcomes

    Time frame: 5 years from surgery

    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.)

  3. Safety analysis

    Time frame: 5 years from surgery

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jiang Hua, PHD

CONTACT

[email protected]

(021)33189900-6529

Xin Wu, PHD

CONTACT

[email protected]

(021)33189900-6529

Sponsors and collaborators

Lead sponsor

Obstetrics & Gynecology Hospital of Fudan University

Other

Collaborators

  • 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

Registry information

Official study title

A Multicenter Noninferior Randomized Controlled Study Comparing the Efficacy of Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB1,IB2,IIA1)

Acronym: LAUNCH 2

Important dates

Study start
2021
Primary completion
2024
Study completion
2026
First posted
Jun 18, 2021
Registry last updated
Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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