Minimally Invasive Therapy Versus Open Radical Hysterectomy 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.

Sex

Female

Minimum age

18 Years

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)

• RESULTWang YZ, Deng L, Xu HC, Zhang Y, Liang ZQ. Laparoscopy versus laparotomy for the management of early stage cervical cancer. BMC Cancer. 2015 Nov 24;15:928. doi: 10.1186/s12885-015-1818-4. PMID 26596955
• RESULTShazly SA, Murad MH, Dowdy SC, Gostout BS, Famuyide AO. Robotic radical hysterectomy in early stage cervical cancer: A systematic review and meta-analysis. Gynecol Oncol. 2015 Aug;138(2):457-71. doi: 10.1016/j.ygyno.2015.06.009. Epub 2015 Jun 6. PMID 26056752
• RESULTMelamed A, Margul DJ, Chen L, Keating NL, Del Carmen MG, Yang J, Seagle BL, Alexander A, Barber EL, Rice LW, Wright JD, Kocherginsky M, Shahabi S, Rauh-Hain JA. Survival after Minimally Invasive Radical Hysterectomy for Early-Stage Cervical Cancer. N Engl J Med. 2018 Nov 15;379(20):1905-1914. doi: 10.1056/NEJMoa1804923. Epub 2018 Oct 31. PMID 30379613
• RESULTRamirez PT, Frumovitz M, Pareja R, Lopez A, Vieira M, Ribeiro R, Buda A, Yan X, Shuzhong Y, Chetty N, Isla D, Tamura M, Zhu T, Robledo KP, Gebski V, Asher R, Behan V, Nicklin JL, Coleman RL, Obermair A. Minimally Invasive versus Abdominal Radical Hysterectomy for Cervical Cancer. N Engl J Med. 2018 Nov 15;379(20):1895-1904. doi: 10.1056/NEJMoa1806395. Epub 2018 Oct 31. PMID 30380365
• RESULTBray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12. PMID 30207593
• RESULTBhatla N, Aoki D, Sharma DN, Sankaranarayanan R. Cancer of the cervix uteri. Int J Gynaecol Obstet. 2018 Oct;143 Suppl 2:22-36. doi: 10.1002/ijgo.12611. PMID 30306584
• RESULTMatsuo K, Machida H, Mandelbaum RS, Konishi I, Mikami M. Validation of the 2018 FIGO cervical cancer staging system. Gynecol Oncol. 2019 Jan;152(1):87-93. doi: 10.1016/j.ygyno.2018.10.026. Epub 2018 Oct 30.