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Keyhole Surgery Compared With Open Surgery for Early Cervical Cancer

Compares keyhole and open removal of the uterus in adults with early cervical cancer.

Key facts

Who runs it
Chang Gung Memorial Hospital
Where
Taoyuan, TaiwanSee the site
Trial code
Registry title
Minimally Invasive Therapy Versus Open Radical Hysterectomy for Management of Early Stage Cervical Cancer
Status
Not yet recruiting
People taking part
820 people, planned
Started
Sept 2023
Expected to end
Jul 2033
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • radical hysterectomy
Record updated
10 February 2023

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women with early stage cervical cancer who will have a radical hysterectomy. It compares keyhole (laparoscopic) surgery with open surgery.

Age
18 years or older
Sex
Women only
Disease stage
Squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the cervix, confirmed by tissue test. Stage IAI (+) LVSI, IA2, IB1, IB2 or IIA1 (2018 FIGO staging).
Earlier treatment
No earlier radiotherapy to the pelvis or abdomen. A past cancer is allowed only if it was more than 5 years ago with no sign of disease now.

Main reasons for not taking part

  • Any other cancer cell type, or stage IB3, IIA2 to IV
  • Spread of cancer seen on scans, lymph nodes larger than 2cm (0.8 in), or lymph nodes with cancer on tissue test
  • Earlier radiotherapy to the pelvis or abdomen
  • Uterus longer than 12 cm (4.7 in)
  • Cannot have surgery, or serious other illness (investigator decides)

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • Patients with histologically confirmed primary squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the uterine cervix
  • Patients with histologically confirmed stage IAI (+) LVSI, IA2, IB1, IB2 and IIA1 disease (TNM and 2018 FIGO staging for carcinoma of the uterine cervix)
  • Patients undergoing a Type II/Type III radical hysterectomy (Piver-Rutledge Classification) or Type B/Type C radical hysterectomy (Querleu-Morrow Classification)
  • 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
  • ECOG Performance Status of 0 or 1
  • Patients who have signed an approved Informed Consent
  • Patients with a prior malignancy if > 5 years ago with no current evidence of disease
  • Females aged 18 years or older
  • Negative serum pregnancy test ≤ 30 days of surgery in premenopausal women and women < 2 years after the onset of menopause

Who cannot take part

  • 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)
  • 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
  • Patients with a history of pelvic or abdominal radiotherapy
  • Patients with any histology other than squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma of the uterine cervix
  • Stage IB3, IIA2-IV (TNM and 2018 FIGO staging for carcinoma of the uterine cervix)
  • Uterine size larger than 12 cm in length

Where in Taiwan

  • Chang Gung Memorial HospitalTaoyuan, TaiwanContact: LEE Chyi-Long, MD-PHDNo longer taking part

About the trial

What the trial wants to find out

Radical hysterectomy and pelvic lymph node dissection (+/- aortic lymph node dissection) is the standard treatment for early stage cervical cancer. And minimally invasive surgery has been successfully and safely demonstrated in the treatment of early stage cervical cancer. This study aims to compare total laparoscopic radical hysterectomy and total abdominal radical hysterectomy in terms of disease-free survival and overall survival. Rates and characteristics of recurrence, incidence of complications and morbidity, impact on quality of life and cost-effectiveness will also be determined.

The 2 groups in the trial

  • Laparoscopic radical hysterectomyTreatment being tested

    Treatment: radical hysterectomy

  • Laparotomic radical hysterectomyExisting treatment, for comparison

    Treatment: radical hysterectomy

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Minimally Invasive Therapy Versus Open Radical Hysterectomy (MITOR) for Management of Early Stage Cervical Cancer
Plain-language title
Keyhole Surgery Compared With Open Surgery for Early Cervical CancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
10 February 2023