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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04831580
Recruitment Status : Recruiting
First Posted : April 5, 2021
Last Update Posted : February 22, 2024
Sponsor:
Collaborator:
Intuitive Foundation
Information provided by (Responsible Party):
GOG Foundation

Study Description
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Brief Summary:
This is a randomized controlled trial to compare survival for patients who undergi robotic assisted laparoscopy versus open radical hysterectomy and lymph node assessment for the treatment of early stage cervical cancer.

Condition or disease Intervention/treatment Phase
Cervical Cancer Device: da Vinci Other: open surgery Not Applicable

Detailed Description:

This is a multi-center, open-label, randomized, non-inferiority clinical trial with the hypothesis that robotically assisted radical hysterectomy with tumor containment prior to colpotomy is non-inferior to abdominal radical hysterectomy with respect to disease free survival.

A t the commencement of surgery, a thorough inspection of all peritoneal surfaces should be performed. The location of any suspected metastatic disease should be documented in the operative report and a biopsy should be performed to confirm the diagnosis. If intraperitoneal disease is detected, the radical hysterectomy should be abandoned. In patients with macroscopic evidence of metastatic disease to the lymph nodes, intraoperative frozen section should be performed to confirm the presence of metastatic disease. Intraoperative management will be left to the discretion of the surgeon. Patients who have confirmed macroscopic lymph node metastases intraoperatively will be excluded from final analysis and replaced due to the controversy surrounding the decision to perform a radical hysterectomy in this setting. Patients in whom the radical hysterectomy is abandoned will be deemed non-evaluable and excluded from final analysis and will be replaced. For all patients, the surgeon should document operative time from incision to close, detailed description of operative findings, intraoperative complications, and blood loss. For patients randomized to the robotic arm, the surgeon should document the use of and specify the type of vaginal manipulator and the reason for conversion to laparotomy (if applicable). Transcervical manipulators are not permitted.

Standard arm: Radical hysterectomy is performed as per standard technique (peon radical hysterectomy (Piver type 2 or 3 or Querleu & Morrow Type B or C) with salpingectomy +/- oophorectomy. Ovaries may be removed or preserved +/- transposition. Prior to colpotomy, the vagina must be closed over the tumor (ie, Wertheim clamps, contour stapling device).

Study arm: Radical hysterectomy is performed as per standard robotic technique (Querleu & Morrow Type B or C) with salpingectomy +/- oophorectomy. Ovaries may be removed or preserved +/- transposition. Colpotomy may be made intracorporally or vaginally. Vagina must be closed prior to intracorporeal colpotomy (see below, #10)

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 840 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial of Robotic Versus Open Radical Hysterectomy for Cervical Cancer (ROCC)
Actual Study Start Date : March 22, 2022
Estimated Primary Completion Date : August 2028
Estimated Study Completion Date : August 2029

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Open radical hysterectomy Other: open surgery
open radical hysterectomy
Experimental: Robotic radical hysterectomy Device: da Vinci
Minimally invasive robotic-assisted surgical device


Outcome Measures
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Primary Outcome Measures :
  1. Survival [ Time Frame: 36 months ]
    3 year disease-free survival


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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.
  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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04831580


Contacts
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Contact: Jennifer Klein, MEd 215-854-0770 jklein@gog.org

Locations
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Sponsors and Collaborators
GOG Foundation
Intuitive Foundation
Investigators
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Study Chair: Kristin Bixel, MD The Ohio State Unversity
More Information
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Responsible Party: GOG Foundation
ClinicalTrials.gov Identifier: NCT04831580    
Other Study ID Numbers: GOG-3043
First Posted: April 5, 2021    Key Record Dates
Last Update Posted: February 22, 2024
Last Verified: February 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
 Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases