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

Primary Purpose

Endometrial Cancer

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Vaginal brachytherapy
Adjuvant radiotherapy (EBRT +/- brachytherapy)
Observation
Sponsored by
Canadian Cancer Trials Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endometrial Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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. 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) (

Sites / Locations

  • Cross Cancer InstituteRecruiting
  • BCCA - Vancouver Cancer CentreRecruiting
  • BCCA - Vancouver Island Cancer CentreRecruiting
  • London Regional Cancer ProgramRecruiting
  • Trillium Health Partners - Credit Valley HospitalRecruiting
  • University Health NetworkRecruiting
  • Leiden University Medical Center (LUMC)

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Sub-study A: RAINBO BLUE Cohort A1

Sub-Study A: RAINBO BLUE Cohort A2 Exploratory

Sub-Study B: TAPER

Arm Description

Observation

Observation or Adjuvant Radiotherapy

Observation or Vaginal Brachytherapy

Outcomes

Primary Outcome Measures

Estimate the rate of pelvic recurrence at 3 years in patients who are treated with de-escalated adjuvant treatment directed by tumour molecular status

Secondary Outcome Measures

Estimate the rate of isolated vaginal recurrence at 3 years
Estimate the rate of para-aortic recurrence at 3 years
Estimate the rate of distant metastasis at 3 years
Estimate recurrence-free survival
Estimate endometrial cancer-specific survival
Estimate overall survival
Describe the impact of molecular classification on patient decisional conflict
Change in level of patient decisional conflict is defined as the change in the Decisional Conflict Scale or subscale prior to and after molecular classification
Describe the impact of molecular classification on fear of recurrence by Fear of Recurrence Inventory

Full Information

First Posted
November 29, 2022
Last Updated
October 13, 2023
Sponsor
Canadian Cancer Trials Group
Collaborators
Canadian Cancer Clinical Trials Network
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1. Study Identification

Unique Protocol Identification Number
NCT05640999
Brief Title
Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER
Official Title
A Phase II Study of Tailored Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endormetrial Cancer (RAINBO BLUE & TAPER)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 19, 2022 (Actual)
Primary Completion Date
December 31, 2028 (Anticipated)
Study Completion Date
June 30, 2029 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Canadian Cancer Trials Group
Collaborators
Canadian Cancer Clinical Trials Network

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrial Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
325 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Sub-study A: RAINBO BLUE Cohort A1
Arm Type
Experimental
Arm Description
Observation
Arm Title
Sub-Study A: RAINBO BLUE Cohort A2 Exploratory
Arm Type
Experimental
Arm Description
Observation or Adjuvant Radiotherapy
Arm Title
Sub-Study B: TAPER
Arm Type
Experimental
Arm Description
Observation or Vaginal Brachytherapy
Intervention Type
Radiation
Intervention Name(s)
Vaginal brachytherapy
Intervention Description
Vaginal brachytherapy should be delivered using a vaginal cylinder, or alternatively ovoids
Intervention Type
Radiation
Intervention Name(s)
Adjuvant radiotherapy (EBRT +/- brachytherapy)
Intervention 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.
Intervention Type
Other
Intervention Name(s)
Observation
Intervention Description
Observation
Primary Outcome Measure Information:
Title
Estimate the rate of pelvic recurrence at 3 years in patients who are treated with de-escalated adjuvant treatment directed by tumour molecular status
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Estimate the rate of isolated vaginal recurrence at 3 years
Time Frame
3 years
Title
Estimate the rate of para-aortic recurrence at 3 years
Time Frame
3 years
Title
Estimate the rate of distant metastasis at 3 years
Time Frame
3 years
Title
Estimate recurrence-free survival
Time Frame
9 years
Title
Estimate endometrial cancer-specific survival
Time Frame
9 years
Title
Estimate overall survival
Time Frame
9 years
Title
Describe the impact of molecular classification on patient decisional conflict
Description
Change in level of patient decisional conflict is defined as the change in the Decisional Conflict Scale or subscale prior to and after molecular classification
Time Frame
9 years
Title
Describe the impact of molecular classification on fear of recurrence by Fear of Recurrence Inventory
Time Frame
9 years

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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. 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) (
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wendy Parulekar
Phone
613-533-6430
Email
wparulekar@ctg.queensu.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathy Han
Organizational Affiliation
University Health Network, Princess Margaret Hospital, Toronto ON Canada
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jessica McAlpine
Organizational Affiliation
BCCA-Vancouver Cancer Centre, Vancouver BC Canada
Official's Role
Study Chair
Facility Information:
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fleur Huang
Phone
780 432-8516
Facility Name
BCCA - Vancouver Cancer Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica McAlpine
Phone
604 877-6000
Ext
2395
Facility Name
BCCA - Vancouver Island Cancer Centre
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline Holloway
Phone
250 519-5609
Facility Name
London Regional Cancer Program
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucas Mendez
Phone
519 685-8600
Ext
53169
Facility Name
Trillium Health Partners - Credit Valley Hospital
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2N1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Katherine Pulman
Phone
905 813-1100
Ext
1841
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathy Han
Phone
416 946-4501
Ext
2919
Facility Name
Leiden University Medical Center (LUMC)
City
Leiden
ZIP/Postal Code
2333ZA
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie De Boer

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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