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

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ClinicalTrials.gov Identifier: NCT05640999
Recruitment Status : Recruiting
First Posted : December 7, 2022
Last Update Posted : March 15, 2024
Sponsor:
Collaborator:
Canadian Cancer Clinical Trials Network
Information provided by (Responsible Party):
Canadian Cancer Trials Group

Study Description
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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

Condition or disease Intervention/treatment Phase
Endometrial Cancer Radiation: Vaginal brachytherapy Radiation: Adjuvant radiotherapy (EBRT +/- brachytherapy) Other: Observation Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 325 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study of Tailored Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endormetrial Cancer (RAINBO BLUE & TAPER)
Actual Study Start Date : December 19, 2022
Estimated Primary Completion Date : December 31, 2028
Estimated Study Completion Date : June 30, 2029
Arms and Interventions
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Arm Intervention/treatment
Experimental: Sub-study A: RAINBO BLUE Cohort A1
Observation
 Other: Observation
Observation
Experimental: Sub-Study A: RAINBO BLUE Cohort A2 Exploratory
Observation or Adjuvant Radiotherapy
 Radiation: Adjuvant radiotherapy (EBRT +/- brachytherapy)
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.

Other: Observation
Observation
Experimental: Sub-Study B: TAPER
Observation or Vaginal Brachytherapy
 Radiation: Vaginal brachytherapy
Vaginal brachytherapy should be delivered using a vaginal cylinder, or alternatively ovoids

Other: Observation
Observation


Outcome Measures
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Primary Outcome Measures :
  1. 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 Measures :
  1. Estimate the rate of isolated vaginal recurrence at 3 years [ Time Frame: 3 years ]
  2. Estimate the rate of para-aortic recurrence at 3 years [ Time Frame: 3 years ]
  3. Estimate the rate of distant metastasis at 3 years [ Time Frame: 3 years ]
  4. Estimate recurrence-free survival [ Time Frame: 9 years ]
  5. Estimate endometrial cancer-specific survival [ Time Frame: 9 years ]
  6. Estimate overall survival [ Time Frame: 9 years ]
  7. Describe the impact of molecular classification on fear of recurrence by Fear of Recurrence Inventory [ Time Frame: 9 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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) (
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05640999


Contacts
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Contact: Wendy Parulekar 613-533-6430 wparulekar@ctg.queensu.ca

Locations
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Australia, New South Wales
Westmead Hospital Recruiting
Westmead, New South Wales, Australia, 2145
Contact: Alison Brand    61 2 8890 6801    alison.brand@health.nsw.gov.au   
Canada, Alberta
Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Fleur Huang    780 432-8516      
Canada, British Columbia
BCCA - Cancer Centre for the Southern Interior Recruiting
Kelowna, British Columbia, Canada, V1Y 5L3
Contact: Hamid Raziee         
BCCA - Centre for the North Recruiting
Prince George, British Columbia, Canada, V2M 7E9
Contact: Allison Ye    250 645-7300      
BCCA - Vancouver Cancer Centre Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Jessica McAlpine    604 877-6000 ext 2395      
BCCA - Vancouver Island Cancer Centre Recruiting
Victoria, British Columbia, Canada, V8R 6V5
Contact: Caroline Holloway    250 519-5609      
Canada, Ontario
London Regional Cancer Program Recruiting
London, Ontario, Canada, N6A 5W9
Contact: Lucas Mendez    519 685-8600 ext 53169      
Trillium Health Partners - Credit Valley Hospital Recruiting
Mississauga, Ontario, Canada, L5M 2N1
Contact: Katherine Pulman    905 813-1100 ext 1841      
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Kathy Han    416 946-4501 ext 2919      
Netherlands
Leiden University Medical Center (LUMC) Recruiting
Leiden, Netherlands, 2333ZA
Contact: Stephanie De Boer         
Sponsors and Collaborators
Canadian Cancer Trials Group
Canadian Cancer Clinical Trials Network
Investigators
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Study Chair: Kathy Han University Health Network, Princess Margaret Hospital, Toronto ON Canada
Study Chair: Jessica McAlpine BCCA-Vancouver Cancer Centre, Vancouver BC Canada
More Information
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Responsible Party: Canadian Cancer Trials Group
ClinicalTrials.gov Identifier: NCT05640999    
Other Study ID Numbers: EN10
First Posted: December 7, 2022    Key Record Dates
Last Update Posted: March 15, 2024
Last Verified: November 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
 Uterine Diseases
Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases