Laparoscopic Approach to Cervical Cancer

The goal of this clinical research study is to compare the long-term outcomes of different surgical methods for the treatment of cervical cancer. The long-term outcome of a total abdominal radical hysterectomy (TARH) will be compared against laparoscopy. In this study, the laparoscopy will be done with or without robotic technology.

Sex

Female

Minimum age

18 Years

Inclusion Criteria:

* Histologically confirmed primary adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix;
* Patients with Histologically confirmed stage IA1 (with lymph vascular invasion), stage IA2, or stage IB1 disease
* Patients undergoing either a Type II or III radical hysterectomy (Piver Classification)
* Patients with adequate bone marrow, renal and hepatic function:
* ECOG Performance Status of 0 or 1.
* Patient must be suitable candidates for surgery.
* Patients who have signed an approved Informed Consent
* Patients with a prior malignancy allowed if \> 5 years ago with no current evidence of disease
* Females, aged 18 years or older
* Negative serum pregnancy test within \<30 days of surgery in pre-menopausal women and women \< 2 years after the onset of menopause

Exclusion Criteria:

* Any histology other than adenocarcinoma, squamous cell carcinoma or adenosquamous carcinoma of the uterine cervix;
* Tumor size greater than 4 cm;
* FIGO stage II-IV;
* Patients with a history of pelvic or abdominal radiotherapy;
* Patients who are pregnant;
* Patients with contraindications to surgery;
* Patients with evidence of metastatic disease by conventional imaging studies, enlarged pelvic or aortic lymph nodes \> 2cm; or histologically positive lymph nodes
* Unfit for Surgery: serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator);
* Patients unable to withstand prolonged lithotomy and steep Trendelenburg position
* Patient compliance and geographic proximity that do not allow adequate follow-up

• BACKGROUNDObermair A, Gebski V, Frumovitz M, Soliman PT, Schmeler KM, Levenback C, Ramirez PT. A phase III randomized clinical trial comparing laparoscopic or robotic radical hysterectomy with abdominal radical hysterectomy in patients with early stage cervical cancer. J Minim Invasive Gynecol. 2008 Sep-Oct;15(5):584-8. doi: 10.1016/j.jmig.2008.06.013. PMID 18722970
• DERIVEDRamirez PT, Robledo KP, Frumovitz M, Pareja R, Ribeiro R, Lopez A, Yan X, Isla D, Moretti R, Bernardini MQ, Gebski V, Asher R, Behan V, Coleman RL, Obermair A. LACC Trial: Final Analysis on Overall Survival Comparing Open Versus Minimally Invasive Radical Hysterectomy for Early-Stage Cervical Cancer. J Clin Oncol. 2024 Aug 10;42(23):2741-2746. doi: 10.1200/JCO.23.02335. Epub 2024 May 29. PMID 38810208
• DERIVEDTanaka T, Ueda S, Miyamoto S, Hashida S, Terada S, Konishi H, Kogata Y, Taniguchi K, Komura K, Ohmichi M. Comparison of Prognosis between Minimally Invasive and Abdominal Radical Hysterectomy for Patients with Early-Stage Cervical Cancer. Curr Oncol. 2022 Mar 24;29(4):2272-2283. doi: 10.3390/curroncol29040185. PMID 35448159
• DERIVEDFrumovitz M, Obermair A, Coleman RL, Pareja R, Lopez A, Ribero R, Isla D, Rendon G, Bernardini MQ, Buda A, Moretti-Marquez R, Zevallos A, Vieira MA, Zhu T, Land RP, Nicklin J, Asher R, Robledo KP, Gebski V, Ramirez PT. Quality of life in patients with cervical cancer after open versus minimally invasive radical hysterectomy (LACC): a secondary outcome of a multicentre, randomised, open-label, phase 3, non-inferiority trial. Lancet Oncol. 2020 Jun;21(6):851-860. doi: 10.1016/S1470-2045(20)30081-4. PMID 32502445
• DERIVEDRamirez 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