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Minimally Invasive Therapy versus Open Radical Hysterectomy (MITOR) for Management of Early Stage Cervical Cancer

Minimally Invasive Therapy versus Open Radical Hysterectomy (MITOR) for Management of Early Stage Cervical Cancer

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000037240
Enrollment
Unknown
Registered
2020-08-27
Start date
2020-08-26
Completion date
Unknown
Last updated
2020-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cervical cancer

Interventions

1:Pelvic Lymph Node Dissection
1: Aortic Lymph Node Dissection
1:Total Laparoscopic Radical Hysterectomy BSO
2:Pelvic Lymph Node Dissection
2:Total Abdominal Radical Hysterectomy BSO
2:Aortic Lymph Node Dissection

Sponsors

Shanghai Tenth People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion 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 10^9 cells/L 4.2 Platelets > 100 x 10^9 cells/L 4.3 Creatinine 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

Exclusion criteria: 1. 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; 2. Patients with a history of pelvic or abdominal radiotherapy; 3. Uterine size larger than 12 cm in length; 4. 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); 5. Patients unable to withstand prolonged lithotomy and steep Trendelenburg position; 6. Patients whose compliance and geographic proximity do not allow adequate follow-up.

Design outcomes

Primary

MeasureTime frame
3-year survival rate;

Countries

China

Contacts

Public ContactZhongping Cheng

Shanghai Tenth People's Hospital

mdcheng18@263.net+86 13816686812

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026