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Recruiting NCT04929769

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

No phase Interventional Cervical Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Total Laparoscopic or Robotic Radical Hysterectomy, Total Abdominal Radical Hysterectomy.
Who it may be relevant to
Registry conditions: Cervical Cancer. Basic parameters: 21 years — 70 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

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.

Interventions

  • Other Total 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.
  • Other Total 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.

Primary outcome measures

  • the rate of PFS at 5 years [Time frame: 5 years from surgery]
Secondary outcome measures (1)
  • the rate of OS at 5 years [Time frame: 5 years from surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • The Obstetrics and Gynecology Hospital of Fudan University — Shanghai

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. PMID 35395868

Identifiers

NCT: NCT04929769 · FUOBGY2021-04

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗