A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer (ROCC)

Brief description of study

The purpose of this study is to investigate if minimally invasive surgery, called robotic assisted laparoscopy (small incision surgery), is better or worse than open surgery (otherwise known as a laparotomy) when performing a radical hysterectomy for cervical cancer. A radical hysterectomy is surgery to remove the uterus, cervix, the parametria (tissue beside the cervix) and the upper part of the vagina; the ovaries, fallopian tubes, and nearby lymph nodes may also be removed. This is the surgical procedure required for the treatment of early stage cervical cancer. Laparoscopy is surgery using long, thin instruments passed through small incisions to perform the surgery. A laparotomy involves a large incision in your abdomen to perform the surgery (up and down or side to side incisions may be used). In general, some studies have shown that minimally invasive surgery causes less pain, shorter hospital stays and fewer complications than open surgery.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions:
Cervical Cancer
Age: 18 Years
Gender: Female

Inclusion Criteria:

Patient must have histologically confirmed adenocarcinoma (usual/classic/NOS), squamous cell carcinoma, adenosquamous carcinoma (Including glassy cell)
Patient must be FIGO Stage IA2, IBI, IB2 (2018 staging) without evidence of definitive parametrial, vaginal, nodal or distant metastases on exam or imaging. Patients with tumor size less than or equal to 4 cm confirmed on MRI prior to randomization are eligible.
Patient must have uterine size <12 cm AND felt to be appropriate for vaginal delivery of the specimen per investigator.
Patient must be suitable surgical candidate with preoperative assessments such as labs and EKG performed per institutional standard.
Patient must be age 18 years or older.
Patient must have ECOG performance status 0-1.
Patient must have a negative urine pregnancy test within 30 days of surgery in pre-menopausal women.
Patient must have signed an approved informed consent and authorization permitting the release of personal health information.

Exclusion Criteria:

Patients with any tumor histology other than those listed above, specifically excluding the following histologies: neuroendocrine, other adenocarcinoma (gastric type, endometrioid, clear cell, serous, signet ring, minimal deviation)
Patients with FIGO stage 1A1, IB3, II-IV (2018 staging).
Patient with inability to receive an MRI.
Patients with a tumor size greater than 4cm or on MRI confirmed prior to randomization are excluded. Patients with definite evidence of vaginal/parametrial involvement on MRI are excluded; if MRI findings are not definitive, then clinical examination must also not reveal parametrial or vaginal extension).
Patients with evidence of metastatic disease (imaging or histologically positive lymph nodes).
Patients with a history of prior pelvic or abdominal radiotherapy.
Patients with a prior malignancy < 5 years from enrollment with the exception of non-melanoma skin cancer.
Patients who are unable to withstand prolonged lithotomy or steep trendelenberg.
Patient compliance and geographic proximity that do not allow adequate follow-up.
Patients with poorly controlled HIV with CD4 counts <500.

Updated on 11 Apr 2024. Study ID: 852048

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