Minimally Invasive Therapy Versus Open Radical Hysterectomy for Management of Early Stage Cervical Cancer

Launched by CHANG GUNG MEMORIAL HOSPITAL · Aug 2, 2021

Keywords

ClinConnect Summary

This clinical trial is studying two types of surgeries for women with early-stage cervical cancer: a traditional open surgery and a newer, less invasive laparoscopic surgery. The goal is to see which method leads to better outcomes, such as survival rates and quality of life after surgery. Researchers will also look at how often the cancer comes back, any complications from the surgeries, and how much each treatment costs.

To participate in this trial, women aged 18 and older who have been diagnosed with specific types of early-stage cervical cancer may be eligible. They should have a good health status and meet certain health criteria, such as normal blood counts and function of their organs. Participants will receive detailed information about the study and will need to give their consent before joining. This trial is not yet open for enrollment, but it aims to provide valuable insights into the best surgical options for treating early-stage cervical cancer.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with histologically confirmed primary squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the uterine cervix
• • 2. Patients with histologically confirmed stage IAI (+) LVSI, IA2, IB1, IB2 and IIA1 disease (TNM and 2018 FIGO staging for carcinoma of the uterine cervix)
• • 3. Patients undergoing a Type II/Type III radical hysterectomy (Piver-Rutledge Classification) or Type B/Type C radical hysterectomy (Querleu-Morrow Classification)
• • 4. Patients with adequate bone marrow, renal and hepatic function using Standard International Units 4.1 WBC \> 3.0 x 109 cells/L 4.2 Platelets \> 100 x 109 cells/L 4.3 Creatinine \< 2.0 mg/dL 4.4 Bilirubin \< 1.5 x upper normal limit and AST/SGOT or ALT/SGPT \< 3 x upper normal limit
• • 5. ECOG Performance Status of 0 or 1
• • 6. Patients who have signed an approved Informed Consent
• • 7. Patients with a prior malignancy if \> 5 years ago with no current evidence of disease
• • 8. Females aged 18 years or older
• • 9. Negative serum pregnancy test ≤ 30 days of surgery in premenopausal women and women \< 2 years after the onset of menopause
• Exclusion Criteria:
• • 1. Patients with any histology other than squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the uterine cervix
• • 2. Stage IB3, IIA2-IV (TNM and 2018 FIGO staging for carcinoma of the uterine cervix)
• • 3. Patients with evidence of metastatic disease by conventional imaging studies (CT Scan, MRI or PET CT Scan), enlarged pelvic or aortic lymph nodes \> 2cm, or histologically positive lymph nodes
• • 4. Patients with a history of pelvic or abdominal radiotherapy
• • 5. Uterine size larger than 12 cm in length
• • 6. Patients with contraindications to surgery or who are unfit for surgery with serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator)