Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT04831580

A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer

Led by GOG Foundation ยท Updated on 2024-12-19

840

Participants Needed

136

Research Sites

384 weeks

Total Duration

On this page

Sponsors

G

GOG Foundation

Lead Sponsor

I

Intuitive Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically confirmed adenocarcinoma (usual/classic/NOS), squamous cell carcinoma, or adenosquamous carcinoma including glassy cell
  • FIGO Stage IA2, IB1, or IB2 cervical cancer without evidence of metastases on exam or imaging
  • Tumor size 4 cm or less confirmed on MRI before randomization
  • Uterine size less than 12 cm and suitable for vaginal specimen delivery
  • Suitable for surgery with standard preoperative assessments completed
  • Age 18 years or older
  • ECOG performance status 0-1
  • Negative urine pregnancy test within 30 days of surgery for pre-menopausal women
  • Signed informed consent and authorization for release of personal health information
Not Eligible

You will not qualify if you...

  • Tumor histology other than those listed, excluding neuroendocrine and other specified adenocarcinomas
  • FIGO stage 1A1, IB3, II-IV cervical cancer
  • Inability to receive MRI
  • Tumor size greater than 4 cm or definite vaginal/parametrial involvement
  • Evidence of metastatic disease or positive lymph nodes
  • History of prior pelvic or abdominal radiotherapy
  • Prior malignancy within 5 years except non-melanoma skin cancer
  • Unable to tolerate prolonged lithotomy or steep Trendelenburg position
  • Non-compliance or geographic inability to attend follow-up
  • Poorly controlled HIV with CD4 counts less than 500

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 136 locations

1

Western Regional Medical Center LLC

Goodyear, Arizona, United States, 85338

Actively Recruiting

2

City of Hope

Duarte, California, United States, 91010

Actively Recruiting

3

University of California San Diego Medical Center

Encinitas, California, United States, 92024

Actively Recruiting

4

City of Hope Orange County Lennar Foundation Cancer

Irvine, California, United States, 92618

Actively Recruiting

5

University of California San Diego Medical Center

La Jolla, California, United States, 92037

Actively Recruiting

6

University of California San Diego Moores Cancer Center

La Jolla, California, United States, 92093

Actively Recruiting

7

Hoag Gynecologic Oncology

Newport Beach, California, United States, 92633

Actively Recruiting

8

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States, 92663

Actively Recruiting

9

Palo Alto Medical Foundation

Palo Alto, California, United States, 94040

Actively Recruiting

10

Stanford Hospital

Palo Alto, California, United States, 94305

Actively Recruiting

11

University of California San Diego Medical Center

San Diego, California, United States, 92103

Actively Recruiting

12

California Pacific Medical Center-Research Institute

San Francisco, California, United States, 91409

Actively Recruiting

13

City of Hope - Upland

Upland, California, United States, 91786

Actively Recruiting

14

University of California San Diego Medical Center

Vista, California, United States, 92081

Actively Recruiting

15

Hartford Healthcare Cancer Institute at Hartford Hospital

Hartford, Connecticut, United States, 06106

Actively Recruiting

16

Hartford Hospital

Hatford, Connecticut, United States, 06102

Actively Recruiting

17

Hartford Healthcare Medical Group-Manchester

Manchester, Connecticut, United States, 06042

Actively Recruiting

18

Harford HealthCare Cancer Institute at the Hospital of Central Connecticut

New Britain, Connecticut, United States, 06053

Actively Recruiting

19

Ascension Medical Group St. Vincent's Obstetrics and Gynecology

Jacksonville, Florida, United States, 32204

Actively Recruiting

20

Mercy Hospital

Miami, Florida, United States, 33133

Actively Recruiting

21

Mount Sinai Comprehensive Cancer Center

Miami, Florida, United States, 33140

Withdrawn

22

South Miami Hospital

Miami, Florida, United States, 33143

Actively Recruiting

23

South Miami Hospital

Miami, Florida, United States, 33143

Actively Recruiting

24

Mercy Hospital

Miami, Florida, United States, 33173

Actively Recruiting

25

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, United States, 33176

Actively Recruiting

26

Miami Cancer Institute at Baptist Health, Inc.

Miami, Florida, United States, 33176

Actively Recruiting

27

Orlando Health Cancer Center

Orlando, Florida, United States, 32806

Withdrawn

28

Orlando Health Winnie Palmer Hospital for Woman and Babies

Orlando, Florida, United States, 32806

Actively Recruiting

29

Tampa General Hospital

Tampa, Florida, United States, 33606

Withdrawn

30

Georgian Cancer Center at Augusta University

Augusta, Georgia, United States, 30912

Actively Recruiting

31

Southeastern Regional Medical Center LLC

Newnan, Georgia, United States, 30265

Actively Recruiting

32

St. Vincent Hospital and Health Care Center Inc

Indianapolis, Indiana, United States, 46260

Withdrawn

33

St. Vincent Hospital and Health Care Center, Inc

Indianapolis, Indiana, United States, 46260

Withdrawn

34

St. Elizabeth Healthcare

Edgewood, Kentucky, United States, 41017

Actively Recruiting

35

Baptist Health Lexington

Lexington, Kentucky, United States, 40503

Actively Recruiting

36

Baptist Health

Lexington, Kentucky, United States, 40503

Actively Recruiting

37

LSU Health New Orleans

New Orleans, Louisiana, United States, 70112

Actively Recruiting

38

Willis-Knighton Physician Network Gynecologic Oncology Associates

Shreveport, Louisiana, United States, 71118

Actively Recruiting

39

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

Scarborough, Maine, United States, 04074

Actively Recruiting

40

Baystate Medical Center

Springfield, Massachusetts, United States, 01199

Withdrawn

41

Minnesota Oncology Hematology

Minneapolis, Minnesota, United States, 55404

Actively Recruiting

42

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

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

43

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

Minneapolis, Minnesota, United States, 55455

Actively Recruiting

44

David C. Pratt Center

St Louis, Missouri, United States, 63141

Actively Recruiting

45

Center of Hope

Reno, Nevada, United States, 89511

Actively Recruiting

46

Memorial Sloan Kettering (Basking Ridge)

Basking Ridge, New Jersey, United States, 07920

Actively Recruiting

47

Memorial Sloan Kettering (Bergen)

Montvale, New Jersey, United States, 07645

Actively Recruiting

48

University of New Mexico Comprehensive Cancer Center

Albuquerque, New Mexico, United States, 87131

Actively Recruiting

49

Northwell Health/South Shore University Hospital

Bay Shore, New York, United States, 11706

Actively Recruiting

50

Northwell Health Physician Partners/Gynecological Oncology at Brightwaters

Brightwaters, New York, United States, 11718

Actively Recruiting

51

Laura and Issac Perlmutter Cancer Center at NYU Langone

Brooklyn, New York, United States, 11220

Actively Recruiting

52

NYU Langone Ambulatory Care Bay Ridge

Brooklyn, New York, United States, 11220

Actively Recruiting

53

NYU Langone Hospital-Brooklym

Brooklyn, New York, United States, 11220

Actively Recruiting

54

Memorial Sloan Kettering (Commack)

Commack, New York, United States, 11725

Actively Recruiting

55

Memorial Sloan Kettering (Westchester)

Harrison, New York, United States, 10604

Actively Recruiting

56

Northwell Health/Huntington Hospital

Huntington, New York, United States, 11743

Actively Recruiting

57

Memorial Sloan Kettering (Monmouth)

Middletown, New York, United States, 07748

Actively Recruiting

58

Northwell Health/Long Island Jewish Medical Center

New Hyde Park, New York, United States, 11040

Actively Recruiting

59

NHPP/Gynecologic Oncology at New Hyde Park

New Hyde Park, New York, United States, 11042

Actively Recruiting

60

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

New York, New York, United States, 10016

Actively Recruiting

61

Laura and Issac Perlmutter Cancer Center at NYU Langone

New York, New York, United States, 10016

Actively Recruiting

62

NYU Langone Medical Center (Tisch Hospital)

New York, New York, United States, 10016

Actively Recruiting

63

The Blavatnik Family - Chelsea Medical Center at Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

64

Josie Robertson Surgery Center

New York, New York, United States, 10065

Actively Recruiting

65

Memorial Sloan Kettering Cancer Center (Main Campus)

New York, New York, United States, 10065

Actively Recruiting

66

Memorial Sloan Kettering (Nassau)

Uniondale, New York, United States, 11553

Actively Recruiting

67

Novant Health Cancer Institute

Charlotte, North Carolina, United States, 28204

Actively Recruiting

68

Duke University Hospital

Durham, North Carolina, United States, 27705

Actively Recruiting

69

Duke Cancer Center

Durham, North Carolina, United States, 27710

Actively Recruiting

70

Duke Cancer Center

Durham, North Carolina, United States, 27710

Actively Recruiting

71

Novant Health Cancer Institute

Greensboro, North Carolina, United States, 27403

Actively Recruiting

72

Novant Health Cancer Institute

Kernersville, North Carolina, United States, 27284

Actively Recruiting

73

Novant Health Cancer Institute

Mount Airy, North Carolina, United States, 27030

Actively Recruiting

74

Novant Health Cancer Institute

North Wilkesboro, North Carolina, United States, 28659

Actively Recruiting

75

FirstHealth Outpatient Cancer Center

Pinehurst, North Carolina, United States, 28374

Actively Recruiting

76

Novant Health Cancer Institute

Statesville, North Carolina, United States, 28625

Actively Recruiting

77

Novant Health Cancer Institute

Thomasville, North Carolina, United States, 27360

Actively Recruiting

78

Novant Health Cancer Institute

Winston-Salem, North Carolina, United States, 27103

Actively Recruiting

79

Summa Health Jean and Milton Copper Pavilion

Akron, Ohio, United States, 44304

Actively Recruiting

80

Summa Health Jean and Milton Copper Pavillion

Akron, Ohio, United States, 44304

Actively Recruiting

81

TriHealth Cancer Institute-Good Samaritan Hospital

Cincinnati, Ohio, United States, 45220

Actively Recruiting

82

TriHealth Cancer Institute-Thomas Comprehensive Care Center

Cincinnati, Ohio, United States, 45220

Actively Recruiting

83

University of Cleveland Medical Center

Cleveland, Ohio, United States, 44106

Actively Recruiting

84

OSU Wexner Medical Center Hospital East

Columbus, Ohio, United States, 43203

Actively Recruiting

85

OSU Wexner Medical Center Outpatient Care East

Columbus, Ohio, United States, 43203

Actively Recruiting

86

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

Columbus, Ohio, United States, 43210

Actively Recruiting

87

OSU Wexner Medical Center University Hospital

Columbus, Ohio, United States, 43210

Actively Recruiting

88

OSU Wexner Medical Center Stefanie Spielman Comprehensive Breast Center

Columbus, Ohio, United States, 43212

Actively Recruiting

89

OSU Wexner Medical Center Martha Morehouse Outpatient Care

Columbus, Ohio, United States, 43221

Actively Recruiting

90

OSU Wexner Medical Center Outpatient Care Upper Arlington

Columbus, Ohio, United States, 43221

Actively Recruiting

91

OSU Wexner Medical Center Outpatient Care Gahanna

Columbus, Ohio, United States, 43230

Actively Recruiting

92

OSU Wexner Medical Center Outpatient Care Dublin

Dublin, Ohio, United States, 43016

Actively Recruiting

93

JamesCare Gynecologic Oncology at Mill Run

Hilliard, Ohio, United States, 43026

Actively Recruiting

94

Kettering Health Cancer Center

Kettering, Ohio, United States, 45429

Actively Recruiting

95

OSU Wexner Medical Center Outpatient Care Lewis Center

Lewis Center, Ohio, United States, 43035

Actively Recruiting

96

OSU Wexner Medical Center Outpatient Care New Albany

Westerville, Ohio, United States, 43081

Actively Recruiting

97

Stephenson Cancer Center

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

98

Legacy Good Samaritan Medical Center-Gynecological Oncology Group

Portland, Oregon, United States, 97210

Withdrawn

99

Providence Center Institute Franz Clinic

Portland, Oregon, United States, 97213

Actively Recruiting

100

Legacy Meridian Park Medical Center-Legacy Medical Gynecologic Oncology

Tualatin, Oregon, United States, 97062

Withdrawn

101

Abington Memorial Hospital

Abington, Pennsylvania, United States, 19001

Actively Recruiting

102

University of Pennsylvania Health System, Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States, 19104

Actively Recruiting

103

Magee - Womens Hospital of UPMC

Pittsburgh, Pennsylvania, United States, 15213

Actively Recruiting

104

AHN West Penn Hospital

Pittsburgh, Pennsylvania, United States, 15224

Actively Recruiting

105

Asplundh Cancer Pavillion

Willow Grove, Pennsylvania, United States, 19090

Actively Recruiting

106

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

Providence, Rhode Island, United States, 02905

Actively Recruiting

107

Chattanooga's Program in Women's Oncology

Chattanooga, Tennessee, United States, 37403

Actively Recruiting

108

The West Clinic, PLLC dba West Cancer Center

Germantown, Tennessee, United States, 38119

Actively Recruiting

109

Texas Oncology-Austin

Austin, Texas, United States, 78758

Actively Recruiting

110

Texas Oncology- GYN ONC DFWW

Bedford, Texas, United States, 76022

Actively Recruiting

111

Texas Oncology-DFWW

Bedford, Texas, United States, 76022

Actively Recruiting

112

Texas Oncology- Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States, 75246

Actively Recruiting

113

University of Texas Southwestern Medical Center-Simmons Cancer Center

Dallas, Texas, United States, 75390

Actively Recruiting

114

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

Dallas, Texas, United States, 75390

Actively Recruiting

115

University of Texas Southwestern Medical Center-Zale Lipshy University Hospital

Dallas, Texas, United States, 75390

Actively Recruiting

116

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390

Actively Recruiting

117

Texas Oncology-GYN ONC DFWW

Fort Worth, Texas, United States, 76104

Actively Recruiting

118

Texas Oncology

Fort Worth, Texas, United States, 76104

Actively Recruiting

119

Texas Oncology-San Antonio

San Antonio, Texas, United States, 78240

Actively Recruiting

120

Texas Oncology-The Woodlands, Gynecologic Oncology

The Woodlands, Texas, United States, 77380

Actively Recruiting

121

University of Virginia Comprehensive Cancer Center

Charlottesville, Virginia, United States, 22903

Actively Recruiting

122

University of Virginia

Charlottesville, Virginia, United States, 22903

Actively Recruiting

123

VCU Health at GreenGate

Henrico, Virginia, United States, 23233

Actively Recruiting

124

VCU Health Emergency Center at New Kent

Quinton, Virginia, United States, 23141

Actively Recruiting

125

Virginia Commonwealth University Massey Cancer Center

Richmond, Virginia, United States, 23219

Actively Recruiting

126

VCU Health Short Pump Pavillion

Richmond, Virginia, United States, 23233

Actively Recruiting

127

VCU Massey Cancer Center at Stony Point

Richmond, Virginia, United States, 23235

Actively Recruiting

128

Virginia Commonwealth University-Main Hospital

Richmond, Virginia, United States, 23298

Actively Recruiting

129

VCU Health at Tappahannock Hospital

Tappahannock, Virginia, United States, 25560

Actively Recruiting

130

VCU Health-William and Mary

Williamsburg, Virginia, United States, 23185

Actively Recruiting

131

Legacy Salmon Creek Medical Center-Legacy Medical Group Gynecologic Oncology

Vancouver, Washington, United States, 98686

Actively Recruiting

132

West Virginia University

Morgantown, West Virginia, United States, 26506

Actively Recruiting

133

West Virginia

Morgantown, West Virginia, United States, 26506

Actively Recruiting

134

University of Wisconsin Clinical Science Center

Madison, Wisconsin, United States, 53792

Actively Recruiting

135

McGill University Health Centre-Glen Site

Montreal, Quebec, Canada, H4A 3J1

Actively Recruiting

136

Centre Hospitalier De L'Universite De Montreal

Montreal, Canada, H2X 3E4

Actively Recruiting

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Research Team

J

Jennifer Klein, MEd

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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A Trial of Robotic Versus Open Hysterectomy Surgery in Cervix Cancer | DecenTrialz