Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT05640999

Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER

Led by Canadian Cancer Trials Group · Updated on 2026-05-12

393

Participants Needed

108

Research Sites

340 weeks

Total Duration

On this page

Sponsors

C

Canadian Cancer Trials Group

Lead Sponsor

C

Canadian Cancer Clinical Trials Network

Collaborating Sponsor

AI-Summary

What this Trial Is About

This protocol tests de-escalated adjuvant treatment in patients with POLE-mutated or p53wt/NSMP (p53 wildtype/no specific molecular profile) early-stage endometrial cancer (EC). Patients may be enrolled in one of two sub-studies * EN10.A/RAINBO BLUE: POLE-mutated EC * EN10.B/TAPER: p53 wildtype / NSMP EC

CONDITIONS

Official Title

Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must have had surgery consisting of hysterectomy and bilateral salpingo-oophorectomy with no visible residual disease
  • Histologically confirmed Stage I to III endometrial carcinoma of any specified subtype
  • Eastern Cooperative Group (ECOG) performance status of 0, 1, or 2
  • HIV-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible
  • Age 18 years or older
  • Patient consent obtained according to local and regulatory requirements
  • Ability and willingness to complete patient-reported outcome questionnaires in English, French, or a validated language
  • Accessibility for treatment and follow-up at the participating center
  • Protocol treatment must begin within 10 weeks of surgery
Not Eligible

You will not qualify if you...

  • Prior neoadjuvant chemotherapy for current endometrial cancer diagnosis
  • Prior pelvic radiation
  • History of other malignancies except treated carcinoma in-situ, non-melanoma skin cancer, or other tumors with no evidence of disease for 5 or more years
  • Clinical evidence of distant metastasis by pre- or post-surgical imaging
  • Documented positive surgical margin
  • Documented positive peritoneal washings if performed

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 108 locations

1

Alaska Womens Cancer Care

Anchorage, Alaska, United States, 99508

Actively Recruiting

2

University of Arizona Cancer Center

Tucson, Arizona, United States, 85719

Actively Recruiting

3

Cedars-Sinai Medical Center

Los Angeles, California, United States, 90048

Actively Recruiting

4

Huntington Memorial Hospital

Pasadena, California, United States, 91105

Actively Recruiting

5

Sutter Medical Center Sacramento

Sacramento, California, United States, 95816

Actively Recruiting

6

UCHealth University of Colorado Hospital

Aurora, Colorado, United States, 80045

Actively Recruiting

7

AdventHealth Porter

Denver, Colorado, United States, 80210

Actively Recruiting

8

University of Miami School of Medicine

Miami, Florida, United States, 33136

Actively Recruiting

9

Sarasota Memorial Hospital - Venice

N. Venice, Florida, United States, 34275

Actively Recruiting

10

Florida Cancer Specialists - Sarasota Downtown

Sarasota, Florida, United States, 34236

Actively Recruiting

11

First Physicians Group-Sarasota

Sarasota, Florida, United States, 34239

Actively Recruiting

12

Sarasota Memorial Hospital

Sarasota, Florida, United States, 34239

Actively Recruiting

13

Sarasota Memorial Health Care Centre

Sarasota, Florida, United States, 34243

Actively Recruiting

14

Florida Cancer Specialists - Venice Pinebrook

Venice, Florida, United States, 34275

Actively Recruiting

15

Grady Health System

Atlanta, Georgia, United States, 30303

Actively Recruiting

16

Emory University Hospital Midtown

Atlanta, Georgia, United States, 30308

Actively Recruiting

17

Piedmont Hospital

Atlanta, Georgia, United States, 30309

Actively Recruiting

18

Emory University Hospital Winship Cancer Institute

Atlanta, Georgia, United States, 30322

Actively Recruiting

19

Emory Saint Josephs Hospital

Atlanta, Georgia, United States, 30342

Actively Recruiting

20

Emory Decatur Hospital

Decatur, Georgia, United States, 30033

Actively Recruiting

21

Northwestern University

Chicago, Illinois, United States, 60611

Actively Recruiting

22

Northwestern Medicine Orland Park

Orland Park, Illinois, United States, 60462

Actively Recruiting

23

Northwestern Medicine Cancer Center Warrenville

Warrenville, Illinois, United States, 60555

Actively Recruiting

24

Ascension Saint Vincent Indianapolis Hospital

Indianapolis, Indiana, United States, 46260

Actively Recruiting

25

Norton Hospital Pavilion and Medical Campus

Louisville, Kentucky, United States, 40202

Actively Recruiting

26

Norton Suburban Hospital and Medical Campus

Louisville, Kentucky, United States, 40207

Actively Recruiting

27

University Medical Center New Orleans

New Orleans, Louisiana, United States, 70112

Actively Recruiting

28

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States, 02114

Actively Recruiting

29

Baystate Medical Center

Springfield, Massachusetts, United States, 01199

Actively Recruiting

30

UMass Memorial Medical Centre

Worcester, Massachusetts, United States, 01605

Actively Recruiting

31

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

32

Nebraska Methodist Hospital

Omaha, Nebraska, United States, 68114

Actively Recruiting

33

Womens Cancer Center of Nevada

Las Vegas, Nevada, United States, 89106

Actively Recruiting

34

Sidney Kimmel Cancer Center Washington Township

Sewell, New Jersey, United States, 08080

Actively Recruiting

35

Mount Sinai Chelsea

New York, New York, United States, 10011

Actively Recruiting

36

Mount Sinai Hospital

New York, New York, United States, 10029

Actively Recruiting

37

Upstate Cancer Center Radiation Oncology at Oswego

Oswego, New York, United States, 13126

Actively Recruiting

38

State University of New York

Syracuse, New York, United States, 13210

Actively Recruiting

39

Upstate Cancer Center at Hill Radiation Oncology

Syracuse, New York, United States, 13210

Actively Recruiting

40

Upstate Cancer Center at Verona

Verona, New York, United States, 13478

Actively Recruiting

41

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

42

Duke University Medical Center

Durham, North Carolina, United States, 27710

Actively Recruiting

43

Duke Womens Cancer Care Raleigh

Raleigh, North Carolina, United States, 27607

Actively Recruiting

44

Case Western Reserve University

Cleveland, Ohio, United States, 44106

Actively Recruiting

45

Ohio State University Comprehensive

Columbus, Ohio, United States, 43210

Actively Recruiting

46

UH Seidman Cancer Center

Mentor, Ohio, United States, 44060

Actively Recruiting

47

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States, 73104

Actively Recruiting

48

Providence Portland Medical Centre

Portland, Oregon, United States, 97213

Actively Recruiting

49

Providence Saint Vincent Medical Center

Portland, Oregon, United States, 97225

Actively Recruiting

50

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, United States, 17033

Actively Recruiting

51

Paoli Memorial Hospital

Paoli, Pennsylvania, United States, 19301

Actively Recruiting

52

Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

53

Asplundh Cancer Pavilion

Willow Grove, Pennsylvania, United States, 19090

Actively Recruiting

54

Lankenau Medical Center

Wynnewood, Pennsylvania, United States, 19096

Actively Recruiting

55

Women and Infants Hospital

Providence, Rhode Island, United States, 02905

Actively Recruiting

56

M.D. Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

57

Farmington Health Centre

Farmington, Utah, United States, 84025

Actively Recruiting

58

University of Utah Sugarhouse Health Centre

Salt Lake City, Utah, United States, 84106

Actively Recruiting

59

Huntsman Cancer Institute University of Utah

Salt Lake City, Utah, United States, 84112

Actively Recruiting

60

University of Vermont Medical Center

Burlington, Vermont, United States, 05401

Actively Recruiting

61

University of Vermont and State Agricultural College

Burlington, Vermont, United States, 05405

Actively Recruiting

62

University of Virginia Cancer Center

Charlottesville, Virginia, United States, 22908

Actively Recruiting

63

Virginia Commonwealth University

Richmond, Virginia, United States, 23298

Actively Recruiting

64

Swedish Medical Center First Hill

Seattle, Washington, United States, 98122

Actively Recruiting

65

Saint Vincent Hospital Cancer Center Green Bay

Green Bay, Wisconsin, United States, 54301

Actively Recruiting

66

Medical College of Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

67

South Western Sydney Local Health District

Liverpool, New South Wales, Australia, 2170

Actively Recruiting

68

Royal North Shore Hospital

St Leonards, New South Wales, Australia, 2065

Actively Recruiting

69

Calvary Mater Newcastle Hospital

Waratah, New South Wales, Australia, 2298

Actively Recruiting

70

Westmead Hospital

Westmead, New South Wales, Australia, 2145

Actively Recruiting

71

Mater Research Institute South Brisbane

South Brisbane, Queensland, Australia, 4101

Actively Recruiting

72

Monash Medical Centre

Clayton, Victoria, Australia, 3168

Actively Recruiting

73

Frankston Hospital

Frankston, Victoria, Australia, 3199

Actively Recruiting

74

The Royal Women's Hospital

Parkville, Victoria, Australia, 3053

Actively Recruiting

75

Canberra Hospital

Garran, Australia, ACT 2605

Actively Recruiting

76

Royal Brisbane and Womens Hospital

Herston, Australia, 4029

Actively Recruiting

77

Arthur J.E. Child Comprehensive Cancer Centre

Calgary, Alberta, Canada, T2N 5G2

Actively Recruiting

78

Cross Cancer Institute

Edmonton, Alberta, Canada, T6G 1Z2

Actively Recruiting

79

BCCA - Kelowna

Kelowna, British Columbia, Canada, V1Y 5L3

Actively Recruiting

80

BCCA - Prince George

Prince George, British Columbia, Canada, V2M 7E9

Actively Recruiting

81

BCCA - Vancouver

Vancouver, British Columbia, Canada, V5Z 4E6

Actively Recruiting

82

BCCA - Victoria

Victoria, British Columbia, Canada, V8R 6V5

Actively Recruiting

83

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada, L4M 6M2

Actively Recruiting

84

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, Canada, L8V 5C2

Not Yet Recruiting

85

London Health Sciences Centre Research Inc.

London, Ontario, Canada, N6A 5W9

Actively Recruiting

86

Trillium Health Partners - Credit Valley Hospital

Mississauga, Ontario, Canada, L5M 2N1

Actively Recruiting

87

Odette Cancer Centre

Toronto, Ontario, Canada, M4N 3M5

Actively Recruiting

88

University Health Network

Toronto, Ontario, Canada, M5G 2M9

Actively Recruiting

89

CHUM-Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada, H2X 3E4

Actively Recruiting

90

The Jewish General Hospital

Montreal, Quebec, Canada, H3T 1E2

Actively Recruiting

91

CIUSSS de l'Estrie - Centre hospitalier

Sherbrooke, Quebec, Canada, J1H 5N4

Actively Recruiting

92

Centre Leon Berard

Lyon, Auvergne-Rhône-Alpes, France, 69008

Actively Recruiting

93

Institut Gustave-Roussy

Villejuif, FR, France, 94805

Actively Recruiting

94

Institut Universitaire du Cancer de Toulouse - IUCT

Toulouse, Occitanie, France, 31100

Actively Recruiting

95

Groupe Hospitalier Diaconesses Croix Saint-Simon

Paris, France, 75012

Actively Recruiting

96

ASST Spedali Civili Brescia

Brescia, Italy, 25123

Actively Recruiting

97

ASST Lecco

Lecco, Italy, 23900

Actively Recruiting

98

European Institute of Oncology

Milan, Italy, 20141

Actively Recruiting

99

Policlinico Umberto I, Universita Sapienza

Rome, Italy, 00161

Actively Recruiting

100

Radiotherapiegroep

Arnhem, Gelderland, Netherlands, 6815AD

Actively Recruiting

101

Maastro clinic (Maastricht UMC)

Maastricht, Limburg, Netherlands, 6229ET

Actively Recruiting

102

Catharina ziekenhuis

Eindhoven, North Brabant, Netherlands, 5623 EJ

Actively Recruiting

103

MC Haaglanden

The Hague, South Holland, Netherlands, 432

Actively Recruiting

104

Leiden University Medical Center (LUMC)

Leiden, Netherlands, 2333ZA

Actively Recruiting

105

Erasmus Medical Center (EMC)

Rotterdam, Netherlands

Actively Recruiting

106

Auckland City Hospital

Auckland, New Zealand, 1023

Actively Recruiting

107

Christchurch Hospital

Christchurch, New Zealand, 8140

Actively Recruiting

108

Oslo University Hospital

Oslo, Ullernchausseen 70, Norway, 0379

Actively Recruiting

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Research Team

W

Wendy Parulekar

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER | DecenTrialz