Comparing laparoscopic and abdominal surgery for early-stage cervical cancer
A Multicenter Noninferior Randomized Controlled Study Comparing the Efficacy of Laparoscopic Versus Abdominal Radical Hysterectomy for Cervical Cancer (Stage IA1 With LVSI, IA2)
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.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 690 (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) |
| Trial ID | NCT04934982 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 IA1 with lymphovascular space invasion (LVSI) and IA2. It is a multicenter, stratified, randomized controlled trial that will assess progression-free survival (PFS) and overall survival (OS) between the two surgical approaches. Additionally, the study will evaluate the impact of surgical detail specifications on outcomes and analyze postoperative complications and quality of life for patients. The findings could provide valuable insights into the optimal surgical approach for this patient population.
Who should consider this trial
Good fit: Ideal candidates include women aged 21 to 70 with a clinical diagnosis of early-stage cervical cancer (IA1 with LVSI or IA2) who meet specific health criteria.
Not a fit: Patients with other malignancies, significant psychiatric disorders, or those who are pregnant will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and survival rates for patients with early-stage cervical cancer.
How similar studies have performed: Previous studies have shown promising results comparing laparoscopic and abdominal approaches in various surgical contexts, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Clinical diagnosis of squamous carcinoma of the cervix, adenocarcinoma, squamous adenocarcinoma (IA1 with lymphovascular interstitial invasion, stage IA2). 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
- The Obstetrics and Gynecology Hospital of Fudan University — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Hua Jiang, PHD — The Obstetrics and Gynecology Hospital of Fudan University
- Study coordinator: Hua Jiang, PHD
- Email: jianghua@fudan.edu.cn
- Phone: (021)33189900-6529
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.