Comparing laparoscopic and abdominal surgery for cervical cancer

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

This study is testing whether laparoscopic surgery is better than traditional abdominal surgery for women with early-stage cervical cancer in terms of survival and recovery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1104 (estimated)
• Ages: 21 Years to 70 Years
• Sex: Female
• Sponsor: Obstetrics & Gynecology Hospital of Fudan University (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT04939831 on ClinicalTrials.gov

What this trial studies

This study aims to compare the effectiveness of laparoscopic radical hysterectomy (LRH) versus abdominal radical hysterectomy (ARH) in patients diagnosed with cervical cancer at stages IB3 and IIA2. It is a multicenter, stratified, randomized controlled trial that will evaluate progression-free survival (PFS) and overall survival (OS) between the two surgical approaches. Additionally, the study will investigate whether specific surgical details can enhance outcomes in the LRH group and assess postoperative complications and quality of life post-surgery.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 21 to 70 with a clinical diagnosis of cervical cancer (squamous carcinoma or adenocarcinoma) at stages IB3 or IIA2.

Not a fit: Patients with a history of other malignancies, serious immune system disorders, or those who are pregnant will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into which surgical method offers better survival outcomes for patients with cervical cancer.

How similar studies have performed: Previous studies comparing laparoscopic and abdominal surgical techniques in various cancers have shown promising results, indicating that this approach is both relevant and potentially beneficial.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• The Obstetrics and Gynecology Hospital of Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Principal investigator: Hua Jiang, PHD — The Obstetrics and Gynecology Hospital of Fudan University
• Study coordinator: Hua Jiang, PHD

Conditions: Cervical Cancer, Abdominal Radical Hysterectomy, Laparoscopic Radical Hysterectomy