Trial Title:
Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER
NCT ID:
NCT05640999
Condition:
Endometrial Cancer
Conditions: Official terms:
Endometrial Neoplasms
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Vaginal brachytherapy
Description:
Vaginal brachytherapy should be delivered using a vaginal cylinder, or alternatively
ovoids
Arm group label:
Sub-Study B: TAPER
Intervention type:
Radiation
Intervention name:
Adjuvant radiotherapy (EBRT +/- brachytherapy)
Description:
Treatment is to be delivered using 4-18 MV photons. MV, kV or CBCT imaging capabilities
are required. Planning systems with capability for DICOM data transfer must be used.
Arm group label:
Sub-Study A: RAINBO BLUE Cohort A2 Exploratory
Intervention type:
Other
Intervention name:
Observation
Description:
Observation
Arm group label:
Sub-Study A: RAINBO BLUE Cohort A2 Exploratory
Arm group label:
Sub-Study B: TAPER
Arm group label:
Sub-study A: RAINBO BLUE Cohort A1
Summary:
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
Detailed description:
This study is being done in order to find out if this new approach is better or worse
than the usual approach for early-stage endometrial cancer. The usual approach is defined
as the care most people get for early-stage endometrial cancer.
The usual approach for patients who are not in a study is treatment with surgery. Tissue
that is removed as part of this procedure is analyzed in the pathology laboratory to
guide the doctor to decide whether or not additional treatment such as radiation and or
chemotherapy should be recommended.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients must have had surgery consisting of hysterectomy and bilateral
salpingo-oophorectomy. Lymph node dissection can be performed as per institutional
standards. There must be no macroscopic residual disease after surgery.
- Patients must have histologically confirmed Stage I to III endometrial carcinoma
which can be endometrioid, serous, clear cell, un/dedifferentiated, carcinosarcoma
or mixed.
- Patients' Eastern Cooperative Group (ECOG) performance status must be 0, 1, or 2.
- HIV-infected patients on effective anti-retroviral therapy with undetectable viral
load within 6 months are eligible for this trial.
- Patients' age must be ≥ 18 years.
- Patient consent must be appropriately obtained in accordance with applicable local
and regulatory requirements.
- Patient is able (i.e. sufficiently fluent) and willing to complete the
patient-reported outcomes (PRO) questionnaires in either English, French or a
validated language
- Patients must be accessible for treatment and follow-up. Patients enrolled on this
trial must be treated and followed at the participating centre
- Protocol treatment is to begin within 10 weeks of hysterectomy/bilateral
salpingo-oophorectomy
Exclusion Criteria:
- Prior Neoadjuvant chemotherapy for current endometrial cancer diagnosis.
- Prior pelvic radiation.
- Patients with a history of other malignancies, except: adequately treated
non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other
solid tumours curatively treated with no evidence of disease for ≥ 5 years.
- Clinical evidence of distant metastasis as determined by pre-surgical or
post-surgical imaging (CT scan of chest, abdomen and pelvis or whole-body PET-CT
scan) (
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UCHealth University of Colorado Hospital
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Bradley Corr
Facility:
Name:
UMass Memorial Medical Centre
Address:
City:
Worcester
Zip:
01605
Country:
United States
Status:
Recruiting
Contact:
Last name:
Susan Zweizig
Phone:
508-856-6265
Facility:
Name:
Sidney Kimmel Cancer Center Washington Township
Address:
City:
Sewell
Zip:
08080
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Mitchell Edelson
Phone:
215-481-4000
Facility:
Name:
Duke University Medical Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Contact:
Last name:
Angeles Secord
Facility:
Name:
University of Oklahoma Health Sciences Center
Address:
City:
Oklahoma City
Zip:
73104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Christina Washington
Phone:
405-271-8777
Facility:
Name:
Thomas Jefferson University
Address:
City:
Philadelphia
Zip:
19107
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Mitchell Edelson
Phone:
215-481-4000
Facility:
Name:
Asplundh Cancer Pavilion
Address:
City:
Willow Grove
Zip:
19090
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Mitchell Edelson
Phone:
215-481-4000
Facility:
Name:
Women and Infants Hospital
Address:
City:
Providence
Zip:
02905
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Matthew Oliver
Phone:
401-274-1122
Phone ext:
48181
Facility:
Name:
University of Utah Sugarhouse Health Centre
Address:
City:
Salt Lake City
Zip:
84106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cristina DeCesaris
Facility:
Name:
Huntsman Cancer Institute University of Utah
Address:
City:
Salt Lake City
Zip:
84112
Country:
United States
Status:
Recruiting
Contact:
Last name:
Cristina DeCesaris
Facility:
Name:
South Western Sydney Local Health District
Address:
City:
Liverpool
Zip:
2170
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Viet Do
Facility:
Name:
Westmead Hospital
Address:
City:
Westmead
Zip:
2145
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Alison Brand
Facility:
Name:
Mater Research Institute South Brisbane
Address:
City:
South Brisbane
Zip:
4101
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Nimithri Cabraal
Facility:
Name:
Monash Medical Centre
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Shih-Ern Yao
Phone:
39 594-6666
Facility:
Name:
Frankston Hospital
Address:
City:
Frankston
Zip:
3199
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Yoland Antill
Facility:
Name:
The Royal Women's Hospital
Address:
City:
Parkville
Zip:
3053
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Orla McNally
Phone:
613 834-5356
Phone ext:
2
Facility:
Name:
Canberra Hospital
Address:
City:
Garran
Zip:
ACT 2605
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Andrew Douglas Lee
Facility:
Name:
Royal Brisbane and Womens Hospital
Address:
City:
Herston
Zip:
4029
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Andrea Garrett
Phone:
73 646-8111
Facility:
Name:
Tom Baker Cancer Centre
Address:
City:
Calgary
Zip:
T2N 4N2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Tien Phan
Phone:
403 521-3926
Facility:
Name:
Cross Cancer Institute
Address:
City:
Edmonton
Zip:
T6G 1Z2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Fleur Huang
Phone:
780 432-8516
Facility:
Name:
BCCA - Kelowna
Address:
City:
Kelowna
Zip:
V1Y 5L3
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Hamid Raziee
Facility:
Name:
BCCA - Prince George
Address:
City:
Prince George
Zip:
V2M 7E9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Allison Ye
Phone:
250 645-7300
Facility:
Name:
BCCA - Vancouver
Address:
City:
Vancouver
Zip:
V5Z 4E6
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Jessica McAlpine
Phone:
604 877-6000
Phone ext:
2395
Facility:
Name:
BCCA - Victoria
Address:
City:
Victoria
Zip:
V8R 6V5
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Caroline Holloway
Phone:
250 519-5609
Facility:
Name:
Verspeeten Family Cancer Centre
Address:
City:
London
Zip:
N6A 5W9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Lucas Mendez
Phone:
519 685-8600
Phone ext:
53169
Facility:
Name:
Trillium Health Partners - Credit Valley Hospital
Address:
City:
Mississauga
Zip:
L5M 2N1
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Katherine Pulman
Phone:
905 813-1100
Phone ext:
1841
Facility:
Name:
Odette Cancer Centre
Address:
City:
Toronto
Zip:
M4N 3M5
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Helen MacKay
Phone:
416 480-5145
Facility:
Name:
University Health Network
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Kathy Han
Phone:
416 946-4501
Phone ext:
2919
Facility:
Name:
CHUM-Centre Hospitalier de l'Universite de Montreal
Address:
City:
Montreal
Zip:
H2X 3E4
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Maroie Barkati
Phone:
514 890-8254
Facility:
Name:
The Jewish General Hospital
Address:
City:
Montreal
Zip:
H3T 1E2
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Susie K.S. Lau
Phone:
514 340-8222
Phone ext:
3114
Facility:
Name:
CIUSSS de l'Estrie - Centre hospitalier
Address:
City:
Sherbrooke
Zip:
J1H 5N4
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Mathieu Viau
Facility:
Name:
European Institute of Oncology
Address:
City:
Milan
Zip:
20141
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Ilaria Betella
Phone:
39 025-7489
Facility:
Name:
Radiotherapiegroep
Address:
City:
Arnhem
Zip:
6815AD
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Dorien Haverkort
Phone:
318 877-9000
Facility:
Name:
Maastro clinic (Maastricht UMC)
Address:
City:
Maastricht
Zip:
6229ET
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Nienke Kuijsters
Phone:
31 088-4456
Phone ext:
0
Facility:
Name:
Catharina ziekenhuis
Address:
City:
Eindhoven
Zip:
5623 EJ
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Bastiaan Wortman
Phone:
40 239-9111
Facility:
Name:
Erasmus Medical Center (EMC)
Address:
City:
Rotterdam
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Henrieke Westerveld
Facility:
Name:
Leiden University Medical Center (LUMC)
Address:
City:
Leiden
Zip:
2333ZA
Country:
Netherlands
Status:
Recruiting
Contact:
Last name:
Stephanie De Boer
Facility:
Name:
Christchurch Hospital
Address:
City:
Christchurch
Zip:
8140
Country:
New Zealand
Status:
Recruiting
Contact:
Last name:
Bryony Simcock
Start date:
December 19, 2022
Completion date:
June 30, 2029
Lead sponsor:
Agency:
Canadian Cancer Trials Group
Agency class:
Other
Collaborator:
Agency:
Canadian Cancer Clinical Trials Network
Agency class:
Other
Source:
Canadian Cancer Trials Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05640999
