Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER
- Conditions
- Endometrial Cancer
- Interventions
- Radiation: Adjuvant radiotherapy (EBRT +/- brachytherapy)Radiation: Vaginal brachytherapyOther: 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 393
- 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
- Prior Neoadjuvant chemotherapy for current endometrial cancer diagnosis.
- Prior pelvic radiation.
- Patients with a history of other malignancies, except: carcinoma in-situ without evidence of invasive disease when resected, adequately treated non-melanoma skin cancer, or other 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)
- Patients with a documented positive surgical margin.
- Patients with a documented positive peritoneal washings, if performed.
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
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
Trial Locations
- Locations (64)
Ohio State University Comprehensive
🇺🇸Columbus, Ohio, United States
Alaska Womens Cancer Care
🇺🇸Anchorage, Alaska, United States
University of Arizona Cancer Center
🇺🇸Tucson, Arizona, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Huntington Memorial Hospital
🇺🇸Pasadena, California, United States
Sutter Medical Center Sacramento
🇺🇸Sacramento, California, United States
UCHealth University of Colorado Hospital
🇺🇸Aurora, Colorado, United States
Piedmont Hospital
🇺🇸Atlanta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Northwestern Medicine Cancer Center Warrenville
🇺🇸Warrenville, Illinois, United States
Ascension Saint Vincent Indianapolis Hospital
🇺🇸Indianapolis, Indiana, United States
University Medical Center New Orleans
🇺🇸New Orleans, Louisiana, United States
UMass Memorial Medical Centre
🇺🇸Worcester, Massachusetts, United States
Sidney Kimmel Cancer Center Washington Township
🇺🇸Sewell, New Jersey, United States
Mount Sinai Chelsea
🇺🇸New York, New York, United States
Mount Sinai Hospital
🇺🇸New York, New York, United States
Upstate Cancer Center Radiation Oncology at Oswego
🇺🇸Oswego, New York, United States
State University of New York
🇺🇸Syracuse, New York, United States
Upstate Cancer Center at Hill Radiation Oncology
🇺🇸Syracuse, New York, United States
Upstate Cancer Center at Verona
🇺🇸Verona, New York, United States
UNC Lineberger Comprehensive Cancer Center
🇺🇸Chapel Hill, North Carolina, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Duke Womens Cancer Care Raleigh
🇺🇸Raleigh, North Carolina, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
Penn State Milton S Hershey Medical Center
🇺🇸Hershey, Pennsylvania, 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
Farmington Health Centre
🇺🇸Farmington, Utah, 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
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
South Western Sydney Local Health District
🇦🇺Liverpool, New South Wales, Australia
Calvary Mater Newcastle Hospital
🇦🇺Waratah, New South Wales, Australia
Westmead Hospital
🇦🇺Westmead, New South Wales, Australia
Mater Research Institute South Brisbane
🇦🇺South Brisbane, Queensland, Australia
Monash Medical Centre
🇦🇺Clayton, Victoria, Australia
Frankston Hospital
🇦🇺Frankston, Victoria, Australia
The Royal Women's Hospital
🇦🇺Parkville, Victoria, Australia
Canberra Hospital
🇦🇺Garran, Australia
Royal Brisbane and Womens Hospital
🇦🇺Herston, Australia
Arthur J.E. Child Comprehensive 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
London Health Sciences Centre Research Inc.
🇨🇦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
MC Haaglanden
🇳🇱Den Haag, South Holland, Netherlands
Leiden University Medical Center (LUMC)
🇳🇱Leiden, Netherlands
Erasmus Medical Center (EMC)
🇳🇱Rotterdam, Netherlands
Auckland City Hospital
🇳🇿Auckland, New Zealand
Christchurch Hospital
🇳🇿Christchurch, New Zealand