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

Chang Gung Medical Foundation

Status

Not yet enrolling

Conditions

Laparoscopic Surgery

Cancer of Cervix

Treatments

Procedure: radical hysterectomy

Study type

Interventional

Funder types

Other

Identifiers

NCT04999696

201902269A3

Details and patient eligibility

About

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.

Full 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.

Enrollment

820 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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)
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
Uterine size larger than 12 cm in length
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)