Recruiting

Robotic vs. Open

Sponsor:

GOG Foundation

Code:

NCT04831580

Conditions

Cervical Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

da Vinci

open surgery

Study Details

Brief 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.

Conditions

Cervical Cancer

Study ID

NCT04831580

Start date

Mar 22, 2022

Status verified date

Jul, 2026

Completion date

Mar, 2030

Anticipated

Primary completion date

Mar, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

840 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Open radical or simple hysterectomy

experimental: Robotic radical or simple hysterectomy

Interventions

da Vinci

Minimally invasive robotic-assisted radical or simple hysterectomy

open surgery

open radical or simple hysterectomy

Primary outcome measure

  • Survival [ Time Frame: 36 months ]

Central Contacts and Locations

Central contacts

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Raechelle Tinsley

RTinsley@coh.org

Principal Investigator:

Mihae Song, MD

University of California San Diego Medical Center

Recruiting

Encinitas, California, United States, 92024

Contacts

Principal Investigator:

Pratibha Binder, MD

City of Hope Orange County Lennar Foundation Cancer

Recruiting

Irvine, California, United States, 92618

Contacts

Raechelle Tinsley

rtinsley@coh.org

Principal Investigator:

Mihae Song, MD

University of California San Diego Medical Center

Recruiting

La Jolla, California, United States, 92037

Contacts

Principal Investigator:

Pratibha Binder, MD

University of California San Diego Moores Cancer Center

Recruiting

La Jolla, California, United States, 92093

Contacts

Principal Investigator:

Ramez Eskander, MD

UCLA Gynecologic Oncology Clinic

Recruiting

Los Angeles, California, United States, 90095

Contacts

Principal Investigator:

Dana Chase, MD

Hoag Gynecologic Oncology

Recruiting

Newport Beach, California, United States, 92633

Contacts

Principal Investigator:

Alberto Meddivil, MD

Hoag Memorial Hospital Presbyterian

Recruiting

Newport Beach, California, United States, 92663

Contacts

Principal Investigator:

Alberto Mendivil, MD

Stanford Hospital

Recruiting

Palo Alto, California, United States, 94305

Contacts

Principal Investigator:

Amer K Karam, MD

University of California San Diego Medical Center

Recruiting

San Diego, California, United States, 92103

Contacts

Principal Investigator:

Pratibha Binder, MD

City of Hope - Upland

Recruiting

Upland, California, United States, 91786

Contacts

Raechelle Tinsley

rtinsley@coh.org

Principal Investigator:

Mihae Song, MD

University of California San Diego Medical Center

Recruiting

Vista, California, United States, 92081

Contacts

Principal Investigator:

Pratibha Binder, MD

Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06102

Contacts

Principal Investigator:

Johathan Cosin, MD

Hartford Healthcare Cancer Institute at Hartford Hospital

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Principal Investigator:

Johathan Cosin, MD

Hartford Healthcare Medical Group-Manchester

Recruiting

Manchester, Connecticut, United States, 06042

Contacts

Principal Investigator:

Johathan Cosin, MD

Harford HealthCare Cancer Institute at the Hospital of Central Connecticut

Recruiting

New Britain, Connecticut, United States, 06053

Contacts

Principal Investigator:

Johathan Cosin, MD

Ascension Medical Group St. Vincent's Obstetrics and Gynecology

Recruiting

Jacksonville, Florida, United States, 32204

Contacts

Principal Investigator:

Martin Martino, MD

Mercy Hospital

Recruiting

Miami, Florida, United States, 33133

Contacts

Principal Investigator:

Ricardo Estape, MD

South Miami Hospital

Recruiting

Miami, Florida, United States, 33143

Contacts

Principal Investigator:

John P Diaz, MD

South Miami Hospital

Recruiting

Miami, Florida, United States, 33143

Contacts

Principal Investigator:

John Diaz, MD

Mercy Hospital

Recruiting

Miami, Florida, United States, 33173

Contacts

Principal Investigator:

Ricardo Estape, MD

Miami Cancer Institute at Baptist Health, Inc.

Recruiting

Miami, Florida, United States, 33176

Contacts

Principal Investigator:

John P Diaz, MD

Miami Cancer Institute at Baptist Health, Inc.

Recruiting

Miami, Florida, United States, 33176

Contacts

Principal Investigator:

John Diaz, MD

Georgian Cancer Center at Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Angela Goebel

agoebel@augusta.edu

Principal Investigator:

Sharad Ghamande, MD

Baptist Health Lexington

Recruiting

Lexington, Kentucky, United States, 40503

Contacts

Principal Investigator:

Hope Cottrill, MD

Baptist Health

Recruiting

Lexington, Kentucky, United States, 40503

Contacts

Principal Investigator:

Hope Cottrill, MD

LSU Health New Orleans

Recruiting

New Orleans, Louisiana, United States, 70112

Contacts

Dina Brackman

dbrack@lsuhsc.edu

Principal Investigator:

Amelia Jernigan, MD

Willis-Knighton Physician Network Gynecologic Oncology Associates

Recruiting

Shreveport, Louisiana, United States, 71118

Contacts

Carrie Key, RN

ckay@wkhs.com

Principal Investigator:

Destin Black, MD

Maine Medical Partners-Woman's Health-Division of Gynecologic Oncology

Recruiting

Scarborough, Maine, United States, 04074

Contacts

Robin Donovan

donovr@mmc.org

Principal Investigator:

Leslie Bradford, MD

Minnesota Oncology Hematology

Recruiting

Minneapolis, Minnesota, United States, 55404

Contacts

Principal Investigator:

Jessica Thomes-Pepin, MD

M Health Fairview University of Minnesota Medical Center-East Bank Hospital

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Erin Zielinksi

eezielin@umn.edu

Principal Investigator:

Colleen Rivard, MD

M Health Fairview University of Minnesota Medical Center-East Bank Hospital

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Erin Zielinksi

eezielin@umn.edu

Principal Investigator:

Collen Rivard, MD

David C. Pratt Center

Recruiting

St Louis, Missouri, United States, 63141

Contacts

Principal Investigator:

Erica Huelsmann, MD

Center of Hope

Recruiting

Reno, Nevada, United States, 89511

Contacts

Shannon White Pierpoint

spierpoint@cohreno.com

Principal Investigator:

Peter Lim, MD

Memorial Sloan Kettering (Basking Ridge)

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Josie Anderson

andersj@mskcc.org

Principal Investigator:

Mario Leitao, MD

Memorial Sloan Kettering (Bergen)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Josie Anderson

andersj@mskcc.org

Principal Investigator:

Mario Leitao, MD

Northwell Health/South Shore University Hospital

Recruiting

Bay Shore, New York, United States, 11706

Contacts

Principal Investigator:

Jill Whyte, MD

Northwell Health Physician Partners/Gynecological Oncology at Brightwaters

Recruiting

Brightwaters, New York, United States, 11718

Contacts

Principal Investigator:

Jill Whyte, MD

Laura and Issac Perlmutter Cancer Center at NYU Langone

Recruiting

Brooklyn, New York, United States, 11220

Contacts

Principal Investigator:

Whitfield Growdon, MD

NYU Langone Ambulatory Care Bay Ridge

Recruiting

Brooklyn, New York, United States, 11220

Contacts

Principal Investigator:

Whitfield Growdon, MD

NYU Langone Hospital-Brooklym

Recruiting

Brooklyn, New York, United States, 11220

Contacts

Principal Investigator:

Whitfield Growdon, MD

Memorial Sloan Kettering (Commack)

Recruiting

Commack, New York, United States, 11725

Contacts

Josie Anderson

andersj@mskcc.org

Principal Investigator:

Mario Leitao, MD

Memorial Sloan Kettering (Westchester)

Recruiting

Harrison, New York, United States, 10604

Contacts

Josie Anderson

andersj@mskcc.org

Principal Investigator:

Mario Leitao, MD

Northwell Health/Huntington Hospital

Recruiting

Huntington, New York, United States, 11743

Contacts

Principal Investigator:

Jill Whyte, MD

Memorial Sloan Kettering (Monmouth)

Recruiting

Middletown, New York, United States, 07748

Contacts

Josie Anderson

andersj@mskcc.org

Principal Investigator:

Mario Leitao, MD

Northwell Health/Long Island Jewish Medical Center

Recruiting

New Hyde Park, New York, United States, 11040

Contacts

Principal Investigator:

Jill Whyte, MD

NHPP/Gynecologic Oncology at New Hyde Park

Recruiting

New Hyde Park, New York, United States, 11042

Contacts

Principal Investigator:

Jill Whyte, MD

Laura and Issac Perlmutter Cancer Center at NYU Langone-East 34th Street

Recruiting

New York, New York, United States, 10016

Contacts

Principal Investigator:

Whitfield Growdon, MD

Laura and Issac Perlmutter Cancer Center at NYU Langone

Recruiting

New York, New York, United States, 10016

Contacts

Principal Investigator:

Whitfield Growdon, MD

NYU Langone Medical Center (Tisch Hospital)

Recruiting

New York, New York, United States, 10016

Contacts

Principal Investigator:

Whitfield Growdon, MD

The Blavatnik Family - Chelsea Medical Center at Mount Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Principal Investigator:

Kristen P Zeligs, MD

Josie Robertson Surgery Center

Recruiting

New York, New York, United States, 10065

Contacts

Josie Anderson

andersj@mskcc.org

Principal Investigator:

Mario Leitao, MD

Memorial Sloan Kettering Cancer Center (Main Campus)

Recruiting

New York, New York, United States, 10065

Contacts

Principal Investigator:

Mario Leitao, MD

Memorial Sloan Kettering (Nassau)

Recruiting

Uniondale, New York, United States, 11553

Contacts

Josie Anderson

andersj@mskcc.org

Principal Investigator:

Mario Leitao, MD

Novant Health Cancer Institute

Recruiting

Charlotte, North Carolina, United States, 28204

Contacts

Principal Investigator:

Elizabeth Skinner, MD

Duke University Hospital

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Principal Investigator:

Emma Rossi, MD

Duke Cancer Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Principal Investigator:

Emma Rossi, MD

Duke Cancer Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Principal Investigator:

Emma Rossi, MD

Novant Health Cancer Institute

Recruiting

Greensboro, North Carolina, United States, 27403

Contacts

Principal Investigator:

Elizabeth Skinner, MD

Novant Health Cancer Institute

Recruiting

Kernersville, North Carolina, United States, 27284

Contacts

Principal Investigator:

Elizabeth Skinner, MD

Novant Health Cancer Institute

Recruiting

Mount Airy, North Carolina, United States, 27030

Contacts

Principal Investigator:

Elizabeth Skinner, MD

Novant Health Cancer Institute

Recruiting

North Wilkesboro, North Carolina, United States, 28659

Contacts

Principal Investigator:

Elizabeth Skinner, MD

Novant Health Cancer Institute

Recruiting

Statesville, North Carolina, United States, 28625

Contacts

Principal Investigator:

Elizabeth Skinner, MD

Novant Health Cancer Institute

Recruiting

Thomasville, North Carolina, United States, 27360

Contacts

Principal Investigator:

Elizabeth Skinner, MD

Novant Health Cancer Institute

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Principal Investigator:

Elizabeth Skinner, MD

Summa Health Jean and Milton Copper Pavilion

Recruiting

Akron, Ohio, United States, 44304

Contacts

Danielle McCutcheon

mccutcheond@summahealth.org

Principal Investigator:

Clarissa Polen, MD

Summa Health Jean and Milton Copper Pavillion

Recruiting

Akron, Ohio, United States, 44304

Contacts

Principal Investigator:

Clarissa De-Polen, MD

University of Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Principal Investigator:

Lindsey Ferguson, MD

OSU Wexner Medical Center Hospital East

Recruiting

Columbus, Ohio, United States, 43203

Contacts

Principal Investigator:

Floor Backes, MD

OSU Wexner Medical Center Outpatient Care East

Recruiting

Columbus, Ohio, United States, 43203

Contacts

Callan Myserscough

callan.myerscough@osumc.edu

Principal Investigator:

Floor Backes, MD

James Cancer Hospital & Solove Research Institute at The Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Floor Backes, MD

OSU Wexner Medical Center University Hospital

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Floor Backes, MD

OSU Wexner Medical Center Stefanie Spielman Comprehensive Breast Center

Recruiting

Columbus, Ohio, United States, 43212

Contacts

Principal Investigator:

Floor Backes, MD

OSU Wexner Medical Center Martha Morehouse Outpatient Care

Recruiting

Columbus, Ohio, United States, 43221

Contacts

Principal Investigator:

Floor Backes, MD

OSU Wexner Medical Center Outpatient Care Upper Arlington

Recruiting

Columbus, Ohio, United States, 43221

Contacts

Principal Investigator:

Floor Backes, MD

OSU Wexner Medical Center Outpatient Care Gahanna

Recruiting

Columbus, Ohio, United States, 43230

Contacts

Principal Investigator:

Floor Backes, MD

OSU Wexner Medical Center Outpatient Care Dublin

Recruiting

Dublin, Ohio, United States, 43016

Contacts

Principal Investigator:

Floor Backes, MD

JamesCare Gynecologic Oncology at Mill Run

Recruiting

Hilliard, Ohio, United States, 43026

Contacts

Principal Investigator:

Floor Backes, MD

Kettering Health Cancer Center

Recruiting

Kettering, Ohio, United States, 45429

Contacts

Principal Investigator:

Thomas Reid, MD

OSU Wexner Medical Center Outpatient Care Lewis Center

Recruiting

Lewis Center, Ohio, United States, 43035

Contacts

Principal Investigator:

Floor Backes, MD

OSU Wexner Medical Center Outpatient Care New Albany

Recruiting

Westerville, Ohio, United States, 43081

Contacts

Principal Investigator:

Floor Backes, MD

Stephenson Cancer Center

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Principal Investigator:

Joan Walker, MD

Providence Center Institute Franz Clinic

Recruiting

Portland, Oregon, United States, 97213

Contacts

Principal Investigator:

Christopher Darus, MD

Abington Memorial Hospital

Recruiting

Abington, Pennsylvania, United States, 19001

Contacts

Principal Investigator:

Mitchell Edelson, MD

University of Pennsylvania Health System, Perelman Center for Advanced Medicine

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Principal Investigator:

Nawr Latif, MD

Magee - Womens Hospital of UPMC

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Jessica Yauch

yauchj@upmc.edu

Principal Investigator:

Alexander Olawaiye, MD

AHN West Penn Hospital

Recruiting

Pittsburgh, Pennsylvania, United States, 15224

Contacts

Principal Investigator:

Sarah Crafton, MD

Asplundh Cancer Pavillion

Recruiting

Willow Grove, Pennsylvania, United States, 19090

Contacts

Principal Investigator:

Mitchell Edelson, MD

Alliance Cancer Specialists, PC

Recruiting

Wynnewood, Pennsylvania, United States, 19096

Contacts

Principal Investigator:

Mark Shahin, MD

Women's and Infants Hospital of Rhode Island Program in Women's Oncology

Recruiting

Providence, Rhode Island, United States, 02905

Contacts

Principal Investigator:

Elizabeth Lokich, MD

Chattanooga's Program in Women's Oncology

Recruiting

Chattanooga, Tennessee, United States, 37403

Contacts

Principal Investigator:

Stephen Depasquale, MD

The West Clinic, PLLC dba West Cancer Center

Recruiting

Germantown, Tennessee, United States, 38119

Contacts

Principal Investigator:

Todd Tillmanns, MD

Texas Oncology-Austin

Recruiting

Austin, Texas, United States, 78758

Contacts

Principal Investigator:

Helen Eshed, MD

Texas Oncology- GYN ONC DFWW

Recruiting

Bedford, Texas, United States, 76022

Contacts

Principal Investigator:

Noelle Cloven, MD

Texas Oncology-DFWW

Recruiting

Bedford, Texas, United States, 76022

Contacts

Principal Investigator:

Mark Messing, MD

Texas Oncology- Baylor Charles A. Sammons Cancer Center

Recruiting

Dallas, Texas, United States, 75246

Contacts

Principal Investigator:

Brandon Sawyer, MD

University of Texas Southwestern Medical Center-Simmons Cancer Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Principal Investigator:

Elizabeth Stock, MD

University of Texas Southwestern Medical Center-WIlliam P. Clements Jr. University Hospital

Recruiting

Dallas, Texas, United States, 75390

Contacts

Principal Investigator:

Elizabeth Stock, MD

University of Texas Southwestern Medical Center-Zale Lipshy University Hospital

Recruiting

Dallas, Texas, United States, 75390

Contacts

Principal Investigator:

Elizabeth Stock, MD

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Principal Investigator:

Elizabeth Stock, MD

Texas Oncology-GYN ONC DFWW

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Principal Investigator:

Noelle Cloven, MD

Texas Oncology

Recruiting

Fort Worth, Texas, United States, 76104

Contacts

Principal Investigator:

Noelle Cloven, MD

Texas Oncology-San Antonio

Recruiting

San Antonio, Texas, United States, 78240

Contacts

Principal Investigator:

Joseph de la Garza, MD

Texas Oncology-The Woodlands, Gynecologic Oncology

Recruiting

The Woodlands, Texas, United States, 77380

Contacts

Principal Investigator:

Christine Lee, MD

University of Virginia Comprehensive Cancer Center

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Principal Investigator:

Leigh Cantrell, MD

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

Contacts

Principal Investigator:

Leigh Cantrell, MD

Inova Health System

Recruiting

Fairfax, Virginia, United States, 22031

Contacts

Principal Investigator:

Leslie Randall, MD

VCU Health at GreenGate

Recruiting

Henrico, Virginia, United States, 23233

Contacts

Sonya Washington

slwashington@vcu.edu

Principal Investigator:

Chelsea Salyer, MD

VCU Health Emergency Center at New Kent

Recruiting

Quinton, Virginia, United States, 23141

Contacts

Principal Investigator:

Chelsea Salyer, MD

Virginia Commonwealth University Massey Cancer Center

Recruiting

Richmond, Virginia, United States, 23219

Contacts

Principal Investigator:

Chelsea Salyer, MD

VCU Health Short Pump Pavillion

Recruiting

Richmond, Virginia, United States, 23233

Contacts

Principal Investigator:

Chelsea Salyer, MD

VCU Massey Cancer Center at Stony Point

Recruiting

Richmond, Virginia, United States, 23235

Contacts

Principal Investigator:

Chelsea Salyer, MD

Virginia Commonwealth University-Main Hospital

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Principal Investigator:

Chelsea Salyer, MD

VCU Health-William and Mary

Recruiting

Williamsburg, Virginia, United States, 23185

Contacts

Principal Investigator:

Chelsea Salyer, MD

West Virginia University

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Principal Investigator:

Krista Phaendler, MD

West Virginia

Recruiting

Morgantown, West Virginia, United States, 26506

Contacts

Principal Investigator:

Krista Pfaendler, MD

University of Wisconsin Clinical Science Center

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Claire Kostechka

kostechka@wisc.edu

Principal Investigator:

Stephen Rose, MD

Princess Margaret Cancer Center

Recruiting

Toronto, Ontario, Canada, M5G2M9

Contacts

Vanessa Ballin

Vanessa.Ballin@uhn.ca

Sarah Ferguson, MD

sarah.ferguson@uhn.ca

Principal Investigator:

Sarah Ferguson, MD

McGill University Health Centre-Glen Site

Recruiting

Montreal, Quebec, Canada, H4A 3J1

Contacts

Principal Investigator:

Xing Zeng, MD

Centre Hospitalier De L'Universite De Montreal

Recruiting

Montreal, Canada, H2X 3E4

Contacts

Principal Investigator:

Vanessa Samouelian, MD

More Information

Sponsor

GOG Foundation

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by GOG Foundation on 2026-07-30.