Comparing robotic and open surgery for early stage cervical cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial aims to compare the survival outcomes of patients undergoing robotic-assisted laparoscopy versus open hysterectomy for early-stage cervical cancer. The study is multi-center and open-label, focusing on the hypothesis that robotic surgery is non-inferior to traditional open surgery in terms of disease-free survival. Patients will be carefully evaluated for eligibility based on specific cancer staging and tumor characteristics before being randomized to one of the two surgical approaches. Detailed documentation of surgical procedures and outcomes will be collected to assess the effectiveness of each method.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patient must have histologically confirmed adenocarcinoma (usual/classic/NOS), squamous cell carcinoma, adenosquamous carcinoma (Including glassy cell)
2. 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.
3. Patient must have uterine size \<12 cm AND felt to be appropriate for vaginal delivery of the specimen per investigator.
4. Patient must be suitable surgical candidate with preoperative assessments such as labs and EKG performed per institutional standard and agree to be randomized to undergo open or robotic radical (or simple) hysterectomy.

   NOTE: Simple hysterectomy will be allowed in patients who meet the following criteria:
   1. pelvic MRI must demonstrate a maximal tumor size of 2 cm or less AND
   2. less than 50% stromal invasion on MRI if tumor present or less than 10 mm of stromal invasion if an excisional (cold knife or LEEP) has been performed.

   Submission of source documents in the GOG Partners Source Document Portal will be required prior to randomization for review and confirmation of simple hysterectomy being met (see Section 6.0 for instructions).
5. Patient must be age 18 years or older.
6. Patient must have ECOG performance status 0-1.
7. Patient must have a negative urine pregnancy test within 30 days of surgery in pre-menopausal women.
8. Patient must have signed an approved informed consent and authorization permitting the release of personal health information.

Exclusion Criteria:

1. 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)
2. Patients with FIGO stage 1A1, IB3, II-IV (2018 staging).
3. Patient with inability to receive an MRI.
4. 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).
5. Patients with evidence of metastatic disease (imaging or histologically positive lymph nodes).
6. Patients with a history of prior pelvic or abdominal radiotherapy.
7. Patients with a prior malignancy \< 5 years from enrollment with the exception of non-melanoma skin cancer.
8. Patients who are unable to withstand prolonged lithotomy or steep trendelenberg.
9. Patient compliance and geographic proximity that do not allow adequate follow-up.
10. Patients with poorly controlled HIV with CD4 counts \<500.

Where it's running

• City of Hope
  Duarte, California, United States Recruiting
• University of California San Diego Medical Center
  Encinitas, California, United States Recruiting
• City of Hope Orange County Lennar Foundation Cancer
  Irvine, California, United States Recruiting
• University of California San Diego Medical Center
  La Jolla, California, United States Recruiting
• University of California San Diego Moores Cancer Center
  La Jolla, California, United States Recruiting
• UCLA Gynecologic Oncology Clinic
  Los Angeles, California, United States Recruiting

+106 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Sarin Chhab
• Email: schhab@gog.org
• Phone: 215-854-0770

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.