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

February 8, 2023 updated by: Chang Gung Memorial Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Radical hysterectomy and pelvic lymph node dissection (+/- aortic lymph node dissection) is the standard treatment for early stage cervical cancer. Laparotomy has been the surgical method of choice for a considerable length of time. While it is an accepted effective treatment, laparotomy is highly invasive and is associated with increased risk of tissue trauma, intraoperative and postoperative complications, and longer hospital stay.

Minimally invasive surgery has been successfully and safely demonstrated in the treatment of early stage cervical cancer. Retrospective studies have shown that oncologic outcomes in terms of recurrence rates and patterns of recurrence are similar in patients who had a laparoscopic or an open approach to radical hysterectomy. There is reduction of overall postoperative complications, treatment-related morbidity and length of hospital stay. However, there are two studies stating poorer survival of women treated by minimally invasive surgery. An epidemiologic study using two large US databases (National Cancer Database and Surveillance, Epidemiology, and End Results database) showed a reduction in overall survival of patients undergoing minimally invasive radical hysterectomy. Furthermore, in a prospective, multi-center, open-label randomized clinical trial, minimally invasive radical hysterectomy (both total laparoscopic and total robotic radical hysterectomy) was associated with significantly worse disease-free survival and overall survival compared to open abdominal radical hysterectomy among women with early stage cervical cancer. Recurrence rates were also higher in the minimally invasive group.

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.

Study Type

Interventional

Enrollment (Anticipated)

820

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Laparoscopic radical hysterectomy
Procedure: radical hysterectomy
To compare disease-free survival and overall survival of patients with early stage cervical cancer undergoing total laparoscopic radical hysterectomy versus total abdominal radical hysterectomy
ACTIVE_COMPARATOR: Laparotomic radical hysterectomy
Procedure: radical hysterectomy
To compare disease-free survival and overall survival of patients with early stage cervical cancer undergoing total laparoscopic radical hysterectomy versus total abdominal radical hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-Free Survival
Time Frame: 5 year
the time from randomization to disease recurrence or death from cervical cancer
5 year
Overall Survival
Time Frame: 5 year
the time from randomization to disease recurrence or death from any cause
5 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence Pattern
Time Frame: 5 years
Recurrences will be described in detail and recorded according to date and location of first recurrence. The location can be designated as local, vault, pelvis or distal metastasis.
5 years
Intraoperative and Postoperative Complications
Time Frame: 1 year
  • Intraoperative complications - hemorrhage; injury to bladder, ureter, bowel; vascular injury; nerve injury
  • Perioperative complications (from post-surgery to discharge from hospital) - genitourinary (urinary tract infection, urinary retention), gastrointestinal (ileus), cardiac (myocardial infarction, atrial fibrillation), pulmonary (edema, atelectasis, pneumonia), renal and cerebrovascular morbidity. Wound and vault complications (infection, breakdown and dehiscence). Septicemia and thromboembolic complications (deep vein thrombosis and pulmonary embolism). Lymphocyst and abscess formation.
  • Early postoperative complications (<4 weeks from surgery): Wound and vault complications (infection, dehiscence). Urinary retention, urinary incontinence. Lymphocyst, lymphedema, abscess formation, or fistula formation.
  • Long term morbidity (4 weeks to 12 months from surgery): Urinary retention, urinary incontinence. lymphedema, incisional hernia formation, vaginal evisceration.
1 year
Impact on Quality of Life
Time Frame: 6 months
Change in quality of life using Functional Assessment of Cancer Therapy Cervical (FACT-Cx) between baseline (pre-surgery) and 6 months after surgery. The FACT-CX comprises 42 items with 5 domains and a score range of 0-168.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2023

Primary Completion (ANTICIPATED)

July 1, 2031

Study Completion (ANTICIPATED)

July 1, 2033

Study Registration Dates

First Submitted

July 12, 2021

First Submitted That Met QC Criteria

August 2, 2021

First Posted (ACTUAL)

August 11, 2021

Study Record Updates

Last Update Posted (ACTUAL)

February 10, 2023

Last Update Submitted That Met QC Criteria

February 8, 2023

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201902269A3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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