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 IB1,IB2,IIA1)

This study is testing whether laparoscopic surgery or traditional abdominal surgery is better for helping women with early-stage cervical cancer live longer and have fewer complications after surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 780 (estimated)
• Ages: 21 Years to 70 Years
• Sex: Female
• Sponsor: Obstetrics & Gynecology Hospital of Fudan University (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT04929769 on ClinicalTrials.gov

What this trial studies

This study aims to determine the differences in patient survival between laparoscopic radical hysterectomy (LRH) and abdominal radical hysterectomy (ARH) for patients with cervical cancer at stages IB1, IB2, and IIA1. 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 more rigorous surgical specifications 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 diagnosed with specific stages of cervical cancer and who meet the health criteria outlined.

Not a fit: Patients with other malignancies, serious immune 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 the most effective surgical approach for improving survival rates in cervical cancer patients.

How similar studies have performed: Previous studies comparing laparoscopic and abdominal surgical techniques 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 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:

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: Xin Wu, PHD — The Obstetrics and Gynecology Hospital of Fudan University
• Study coordinator: Xin Wu, PHD

Conditions Cervical Cancer; Abdominal Radical Hysterectomy; Laparoscopic Radical Hysterectomy