A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer

NCT04831580RecruitingNAINTERVENTIONAL

Summary

This is a randomized controlled trial to compare survival for patients who undergoe robotic assisted laparoscopy versus open hysterectomy and lymph node assessment for the treatment of early stage cervical cancer.

Key Facts

Lead Sponsor

GOG Foundation

Enrollment

840

Start Date

2022-03-22

Completion Date

2028-08-01

Study Type

INTERVENTIONAL

Official Title

A Randomized Controlled Trial of Robotic Versus Open Surgery for Early Stage Cervical Cancer (ROCC)

Interventions

da Vinciopen surgery

Conditions

Cervical Cancer

Eligibility

Age Range

18 Years+

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Survival

3 year disease-free survival

Time frame: 36 months

Locations

Western Regional Medical Center LLC, Goodyear, United States

City of Hope, Duarte, United States

University of California San Diego Medical Center, Encinitas, United States

City of Hope Orange County Lennar Foundation Cancer, Irvine, United States

University of California San Diego Medical Center, La Jolla, United States

University of California San Diego Moores Cancer Center, La Jolla, United States

Hoag Gynecologic Oncology, Newport Beach, United States

Hoag Memorial Hospital Presbyterian, Newport Beach, United States

Palo Alto Medical Foundation, Palo Alto, United States

Stanford Hospital, Palo Alto, United States

University of California San Diego Medical Center, San Diego, United States

California Pacific Medical Center-Research Institute, San Francisco, United States

City of Hope - Upland, Upland, United States

University of California San Diego Medical Center, Vista, United States

Hartford Healthcare Cancer Institute at Hartford Hospital, Hartford, United States

Hartford Hospital, Hatford, United States

Hartford Healthcare Medical Group-Manchester, Manchester, United States

Harford HealthCare Cancer Institute at the Hospital of Central Connecticut, New Britain, United States

Ascension Medical Group St. Vincent's Obstetrics and Gynecology, Jacksonville, United States

Mercy Hospital, Miami, United States

Mount Sinai Comprehensive Cancer Center, Miami, United States

South Miami Hospital, Miami, United States

South Miami Hospital, Miami, United States

Mercy Hospital, Miami, United States

Miami Cancer Institute at Baptist Health, Inc., Miami, United States

Miami Cancer Institute at Baptist Health, Inc., Miami, United States

Orlando Health Cancer Center, Orlando, United States

Orlando Health Winnie Palmer Hospital for Woman and Babies, Orlando, United States

Tampa General Hospital, Tampa, United States

Georgian Cancer Center at Augusta University, Augusta, United States

Southeastern Regional Medical Center LLC, Newnan, United States

St. Vincent Hospital and Health Care Center Inc, Indianapolis, United States

St. Vincent Hospital and Health Care Center, Inc, Indianapolis, United States

St. Elizabeth Healthcare, Edgewood, United States

Baptist Health Lexington, Lexington, United States

Baptist Health, Lexington, United States

LSU Health New Orleans, New Orleans, United States

Willis-Knighton Physician Network Gynecologic Oncology Associates, Shreveport, United States

Maine Medical Partners-Woman's Health-Division of Gynecologic Oncology, Scarborough, United States

Baystate Medical Center, Springfield, United States

Minnesota Oncology Hematology, Minneapolis, United States

M Health Fairview University of Minnesota Medical Center-East Bank Hospital, Minneapolis, United States

M Health Fairview University of Minnesota Medical Center-East Bank Hospital, Minneapolis, United States

David C. Pratt Center, St Louis, United States

Center of Hope, Reno, United States

Memorial Sloan Kettering (Basking Ridge), Basking Ridge, United States

Memorial Sloan Kettering (Bergen), Montvale, United States

University of New Mexico Comprehensive Cancer Center, Albuquerque, United States

Northwell Health/South Shore University Hospital, Bay Shore, United States

Northwell Health Physician Partners/Gynecological Oncology at Brightwaters, Brightwaters, United States

Laura and Issac Perlmutter Cancer Center at NYU Langone, Brooklyn, United States

NYU Langone Ambulatory Care Bay Ridge, Brooklyn, United States

NYU Langone Hospital-Brooklym, Brooklyn, United States

Memorial Sloan Kettering (Commack), Commack, United States

Memorial Sloan Kettering (Westchester), Harrison, United States

Northwell Health/Huntington Hospital, Huntington, United States

Memorial Sloan Kettering (Monmouth), Middletown, United States

Northwell Health/Long Island Jewish Medical Center, New Hyde Park, United States

NHPP/Gynecologic Oncology at New Hyde Park, New Hyde Park, United States

Laura and Issac Perlmutter Cancer Center at NYU Langone-East 34th Street, New York, United States

Laura and Issac Perlmutter Cancer Center at NYU Langone, New York, United States

NYU Langone Medical Center (Tisch Hospital), New York, United States

The Blavatnik Family - Chelsea Medical Center at Mount Sinai, New York, United States

Josie Robertson Surgery Center, New York, United States

Memorial Sloan Kettering Cancer Center (Main Campus), New York, United States

Memorial Sloan Kettering (Nassau), Uniondale, United States

Novant Health Cancer Institute, Charlotte, United States

Duke University Hospital, Durham, United States

Duke Cancer Center, Durham, United States

Duke Cancer Center, Durham, United States

Novant Health Cancer Institute, Greensboro, United States

Novant Health Cancer Institute, Kernersville, United States

Novant Health Cancer Institute, Mount Airy, United States

Novant Health Cancer Institute, North Wilkesboro, United States

FirstHealth Outpatient Cancer Center, Pinehurst, United States

Novant Health Cancer Institute, Statesville, United States

Novant Health Cancer Institute, Thomasville, United States

Novant Health Cancer Institute, Winston-Salem, United States

Summa Health Jean and Milton Copper Pavilion, Akron, United States

Summa Health Jean and Milton Copper Pavillion, Akron, United States

TriHealth Cancer Institute-Good Samaritan Hospital, Cincinnati, United States

TriHealth Cancer Institute-Thomas Comprehensive Care Center, Cincinnati, United States

University of Cleveland Medical Center, Cleveland, United States

OSU Wexner Medical Center Hospital East, Columbus, United States

OSU Wexner Medical Center Outpatient Care East, Columbus, United States

James Cancer Hospital & Solove Research Institute at The Ohio State University Comprehensive Cancer Center, Columbus, United States

OSU Wexner Medical Center University Hospital, Columbus, United States

OSU Wexner Medical Center Stefanie Spielman Comprehensive Breast Center, Columbus, United States

OSU Wexner Medical Center Martha Morehouse Outpatient Care, Columbus, United States

OSU Wexner Medical Center Outpatient Care Upper Arlington, Columbus, United States

OSU Wexner Medical Center Outpatient Care Gahanna, Columbus, United States

OSU Wexner Medical Center Outpatient Care Dublin, Dublin, United States

JamesCare Gynecologic Oncology at Mill Run, Hilliard, United States

Kettering Health Cancer Center, Kettering, United States

OSU Wexner Medical Center Outpatient Care Lewis Center, Lewis Center, United States

OSU Wexner Medical Center Outpatient Care New Albany, Westerville, United States

Stephenson Cancer Center, Oklahoma City, United States

Legacy Good Samaritan Medical Center-Gynecological Oncology Group, Portland, United States

Providence Center Institute Franz Clinic, Portland, United States

Legacy Meridian Park Medical Center-Legacy Medical Gynecologic Oncology, Tualatin, United States

Abington Memorial Hospital, Abington, United States

University of Pennsylvania Health System, Perelman Center for Advanced Medicine, Philadelphia, United States

Magee - Womens Hospital of UPMC, Pittsburgh, United States

AHN West Penn Hospital, Pittsburgh, United States

Asplundh Cancer Pavillion, Willow Grove, United States

Women's and Infants Hospital of Rhode Island Program in Women's Oncology, Providence, United States

Chattanooga's Program in Women's Oncology, Chattanooga, United States

The West Clinic, PLLC dba West Cancer Center, Germantown, United States

Texas Oncology-Austin, Austin, United States

Texas Oncology- GYN ONC DFWW, Bedford, United States

Texas Oncology-DFWW, Bedford, United States

Texas Oncology- Baylor Charles A. Sammons Cancer Center, Dallas, United States

University of Texas Southwestern Medical Center-Simmons Cancer Center, Dallas, United States

University of Texas Southwestern Medical Center-WIlliam P. Clements Jr. University Hospital, Dallas, United States

University of Texas Southwestern Medical Center-Zale Lipshy University Hospital, Dallas, United States

University of Texas Southwestern Medical Center, Dallas, United States

Texas Oncology-GYN ONC DFWW, Fort Worth, United States

Texas Oncology, Fort Worth, United States

Texas Oncology-San Antonio, San Antonio, United States

Texas Oncology-The Woodlands, Gynecologic Oncology, The Woodlands, United States

University of Virginia Comprehensive Cancer Center, Charlottesville, United States

University of Virginia, Charlottesville, United States

VCU Health at GreenGate, Henrico, United States

VCU Health Emergency Center at New Kent, Quinton, United States

Virginia Commonwealth University Massey Cancer Center, Richmond, United States

VCU Health Short Pump Pavillion, Richmond, United States

VCU Massey Cancer Center at Stony Point, Richmond, United States

Virginia Commonwealth University-Main Hospital, Richmond, United States

VCU Health at Tappahannock Hospital, Tappahannock, United States

VCU Health-William and Mary, Williamsburg, United States

Legacy Salmon Creek Medical Center-Legacy Medical Group Gynecologic Oncology, Vancouver, United States

West Virginia University, Morgantown, United States

West Virginia, Morgantown, United States

University of Wisconsin Clinical Science Center, Madison, United States

McGill University Health Centre-Glen Site, Montreal, Canada

Centre Hospitalier De L'Universite De Montreal, Montreal, Canada

Linked Papers

2025-02-28

ROCC/GOG-3043: a randomized controlled trial of robotic versus open surgery for early-stage cervical cancer

The Laparoscopic Approach to Cervical Cancer trial is the only randomized trial to date addressing the role of surgical approach in cervical cancer; however, this non-inferiority trial of minimally invasive surgery vs an open approach in patients undergoing radical hysterectomy for early-stage cervical cancer did not meet its primary end point of 4.5-year disease-free survival and was terminated early because of significantly worse disease-specific survival, overall survival, and locoregional recurrence in the minimally invasive surgery cohort. Our trial compares 3-year disease-free survival after robotic-assisted or abdominal radical or simple (in select cases) hysterectomy in early-stage cervical cancer. We hypothesize that disease-free survival is non-inferior after robotic-assisted vs abdominal radical or simple hysterectomy. This multi-center, randomized non-inferiority trial conducted through the Gynecologic Oncology Group has specified surgeon qualification criteria. It requires a pelvic magnetic resonance imaging scan in all patients before enrollment and will use 1:1 randomization to assign patients to robotic-assisted or abdominal hysterectomy. All surgeons must use specified tumor-containment techniques in both arms. It does not allow trans-cervical uterine manipulators. Patients with early-stage (2018 International Federation of Gynecology and Obstetrics stages IA2-IB2) cervical cancer. Histologic types are limited to squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma. Pelvic magnetic resonance imaging must confirm a tumor that is 4 cm or less without definitive extra-cervical spread. A simple hysterectomy is allowed in select cases after trial study principal investigator review. The primary end point is the 3-year disease-free survival between robotic-assisted or abdominal hysterectomy. The trial will randomly allocate 840 patients, with planned interim analysis for futility (oncologic safety) after we have randomly allocated 370 and 640 patients. 2030. ClinicalTrials.gov identifier: NCT04831580.

2023-07-25

Emerging Treatment Options for Cervical Dysplasia and Early Cervical Cancer

Discussion of treatment strategies for cervical cancer precursors, review of medical therapies and emerging therapeutics for treatment of cervical cancers, and updates on new approaches to treating early-stage cervical cancers.

Linked Investigators

Allison Quick

Colleen McCormick

Dana M. Chase

Joan L. Walker

Mario M Leitao