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

Phase 2

Recruiting

• Conditions: Endometrial Cancer
• Interventions: Radiation: Adjuvant radiotherapy (EBRT +/- brachytherapy); Radiation: Vaginal brachytherapy; Other: Observation

• Registration Number: NCT05640999
• Lead Sponsor: Canadian Cancer Trials Group

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.

Study Timeline

• Study First Submitted: 2022-11-29
• Study First Submitted QC: 2022-11-29
• Study First Posted: 2022-12-07
• Study Start: 2022-12-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-11
• Primary Completion: 2028-12-31
• Study Completion: 2029-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 325

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

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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) (

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sub-Study A: RAINBO BLUE Cohort A2 Exploratory	Adjuvant radiotherapy (EBRT +/- brachytherapy)	Observation or Adjuvant Radiotherapy
Sub-Study B: TAPER	Observation	Observation or Vaginal Brachytherapy
Sub-study A: RAINBO BLUE Cohort A1	Observation	Observation
Sub-Study A: RAINBO BLUE Cohort A2 Exploratory	Observation	Observation or Adjuvant Radiotherapy
Sub-Study B: TAPER	Vaginal brachytherapy	Observation or Vaginal Brachytherapy

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Estimate recurrence-free survival	9 years
Estimate the rate of distant metastasis at 3 years	3 years
Estimate overall survival	9 years
Describe the impact of molecular classification on fear of recurrence by Fear of Recurrence Inventory	9 years
Estimate the rate of isolated vaginal recurrence at 3 years	3 years
Estimate the rate of para-aortic recurrence at 3 years	3 years
Estimate endometrial cancer-specific survival	9 years

Trial Locations

Locations (42)

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Duke Womens Cancer Care Raleigh; 🇺🇸 Raleigh, North Carolina, United States

Farmington Health Centre; 🇺🇸 Farmington, Utah, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

UCHealth University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

UMass Memorial Medical Centre; 🇺🇸 Worcester, Massachusetts, United States

Sidney Kimmel Cancer Center Washington Township; 🇺🇸 Sewell, New Jersey, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States

Thomas Jefferson University; 🇺🇸 Philadelphia, Pennsylvania, United States

Asplundh Cancer Pavilion; 🇺🇸 Willow Grove, Pennsylvania, United States

Women and Infants Hospital; 🇺🇸 Providence, Rhode Island, United States

University of Utah Sugarhouse Health Centre; 🇺🇸 Salt Lake City, Utah, United States

Huntsman Cancer Institute University of Utah; 🇺🇸 Salt Lake City, Utah, United States

South Western Sydney Local Health District; 🇦🇺 Liverpool, New South Wales, Australia

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia

Mater Research Institute South Brisbane; 🇦🇺 South Brisbane, Queensland, Australia

The Royal Women's Hospital; 🇦🇺 Carlton, Victoria, Australia

Monash Medical Centre; 🇦🇺 Clayton, Victoria, Australia

Frankston Hospital; 🇦🇺 Frankston, Victoria, Australia

Canberra Hospital; 🇦🇺 Garran, Australia

Royal Brisbane and Womens Hospital; 🇦🇺 Herston, Australia

Tom Baker Cancer Centre; 🇨🇦 Calgary, Alberta, Canada

Cross Cancer Institute; 🇨🇦 Edmonton, Alberta, Canada

BCCA - Kelowna; 🇨🇦 Kelowna, British Columbia, Canada

BCCA - Prince George; 🇨🇦 Prince George, British Columbia, Canada

BCCA - Vancouver; 🇨🇦 Vancouver, British Columbia, Canada

BCCA - Victoria; 🇨🇦 Victoria, British Columbia, Canada

Verspeeten Family Cancer Centre; 🇨🇦 London, Ontario, Canada

Trillium Health Partners - Credit Valley Hospital; 🇨🇦 Mississauga, Ontario, Canada

Odette Cancer Centre; 🇨🇦 Toronto, Ontario, Canada

University Health Network; 🇨🇦 Toronto, Ontario, Canada

CHUM-Centre Hospitalier de l'Universite de Montreal; 🇨🇦 Montreal, Quebec, Canada

The Jewish General Hospital; 🇨🇦 Montreal, Quebec, Canada

CIUSSS de l'Estrie - Centre hospitalier; 🇨🇦 Sherbrooke, Quebec, Canada

European Institute of Oncology; 🇮🇹 Milan, Italy

Radiotherapiegroep; 🇳🇱 Arnhem, Gelderland, Netherlands

Maastro clinic (Maastricht UMC); 🇳🇱 Maastricht, Limburg, Netherlands

Catharina ziekenhuis; 🇳🇱 Eindhoven, Noord Brabant, Netherlands

Erasmus Medical Center (EMC); 🇳🇱 Rotterdam, The Netherlands, Netherlands

Leiden University Medical Center (LUMC); 🇳🇱 Leiden, Netherlands

Christchurch Hospital; 🇳🇿 Christchurch, New Zealand