Minimally Invasive Radical Hysterectomy Using Endoscopic Stapler in Stage IB2 or IIA1 Cervical Ca… (NCT07256977) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Minimally Invasive Radical Hysterectomy Using Endoscopic Stapler in Stage IB2 or IIA1 Cervical Cancer
South Korea494 participantsStarted 2026-01-01
Plain-language summary
This study is a multicenter, open-label, non-inferiority, randomized controlled, investigator-initiated clinical trial comparing the efficacy and safety of open radical hysterectomy versus minimally invasive radical hysterectomy using an endoscopic stapler as surgical treatments for early cervical cancer.
Who can participate
Age range20 Years
SexFEMALE
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Inclusion criteria
✓. 2018 FIGO stage IB2 or IIA1 cervical cancer (tumor maximum diameter ≥2 cm and \<4 cm)
✓. Histologically confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
✓. Planned for Type B or C radical hysterectomy
✓. With adequate bone marrow, renal, and hepatic function
✓. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
✓. Previous history of other invasive malignancies with no evidence of recurrence for at least 5 years
✓. Signed and approved consent form
Exclusion criteria
✕. Histological types other than squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma
✕. Tumor size less than 2 cm classified as 2018 FIGO stage IA1, IA2, or IB1 disease
✕. The following are observed on preoperative CT or MRI
✕. Prior pelvic or abdominal radiotherapy
✕. Prior neoadjuvant chemotherapy before surgery
✕. Unsuitable for surgery due to severe systemic disease at the investigator's discretion