NCT04999696Not yet recruiting
Minimally Invasive Therapy Versus Open Radical Hysterectomy for Management of Early Stage Cervical Cancer
Minimally Invasive Therapy Versus Open Radical Hysterectomy (MITOR) for Management of Early Stage Cervical Cancer
Source: ClinicalTrials.gov · Last updated 10 Feb 2023 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 820 (estimated)
- First submitted
- 12 Jul 2021
- Start date
- Sept 2023
- Primary completion date
- Jul 2031
- Lead sponsor
- Chang Gung Memorial Hospital
- Diseases
- Cervical cancer
- NCT number
- NCT04999696
What you commit to
- Study type: Interventional
- Planned participants: 820
- From Sept 2023 to the primary completion date, Jul 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chang Gung Memorial Hospital Coordinator of this site? Confirm its status | Taoyuan | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.