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Laparoscopic or Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB3,IIA2)

NCT04939831RecruitingNAINTERVENTIONAL

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 IB3, IIA2).

Key Facts

Lead Sponsor

Obstetrics & Gynecology Hospital of Fudan University

Enrollment

1104

Start Date

2021-05-12

Completion Date

2024-06-01

Study Type

INTERVENTIONAL

Official Title

A Multicenter Noninferior Randomized Controlled Study Comparing the Efficacy of Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer(Stage IB3,IIA2)

Interventions

Total Laparoscopic or Robotic Radical HysterectomyTotal Abdominal Radical Hysterectomy

Conditions

Cervical Cancer

Eligibility

Age Range

21 Years – 70 Years

Sex

FEMALE

Inclusion Criteria:

1. Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (Stage IB3,IIA2).
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.

Outcome Measures

Primary Outcomes

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.)

Time frame: 5 years from surgery

Secondary Outcomes

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

Locations

The Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China

Linked Papers

2023-08-18

A multicenter noninferior randomized controlled study comparing the efficacy of laparoscopic versus abdominal radical hysterectomy for cervical cancer (stage IB3 and IIA2): study protocol of the LAUNCH 3 trial

Abstract Background Cervical cancer is and will remain to be an important health problem in China, especially with an increasing proportion of younger patients who has more specific needs. In China, surgery to remove tumor burden followed by postoperative treatment with radiotherapy and chemotherapy based on clinicopathologic factors may be the best choice for stages IB3 and IIA2 patients. Radical hysterectomy in cervical cancer has been a classic landmark surgery in gynecology. The current trial is designed to evaluate whether there is a difference between laparoscopic RH and abdominal RH in cervical cancer (stages IB3 and IIA2) patient survival under stringent operation standards and consistent surgical oncologic principles. This paper reports the rationale, design, and implementation of the trial. Methods/design This is an investigator-initiated, prospective, randomized, open, blinded endpoint (PROBE) controlled trial. A total of 1104 patients with stage IB3 and IIA2 cervical cancer will be enrolled over a period of 3 years. Patients are randomized (1:1) to either the laparoscopic RH or the abdominal RH group. Patients will then be followed up for at least 5 years. The primary end point will be 5-year overall survival, and secondary endpoints include 5-year progression-free survival, recurrence, and quality of life measurements. Discussion The study results will provide more convincing evidence-based information for stages IB3 and IIA2 cervical cancer patients and their gynecologic cancer surgeons in their choice of surgical method. Trial registration ClinicalTrials.gov, NCT04939831, retrospectively registered on 25 June 2021.

Linked Investigators

Yan Du