Actively Recruiting
Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features
Led by Leiden University Medical Center · Updated on 2024-11-29
1615
Participants Needed
14
Research Sites
476 weeks
Total Duration
On this page
Sponsors
L
Leiden University Medical Center
Lead Sponsor
I
Institute Gustave Roussy (sponsor p53abn-RED trial)
Collaborating Sponsor
AI-Summary
What this Trial Is About
The RAINBO umbrella program consists of four clinical trials investigating new adjuvant therapies in endometrial cancer patients. Eligible patients will be assigned to one of the four RAINBO trials based on the molecular profile of their cancer: * p53 abnormal endometrial cancer patients to the p53abn-RED trial * mismatch repair deficient endometrial cancer patients to the MMRd-GREEN trial * no specific molecular profile endometrial cancer patients to NSMP-ORANGE trial * POLE mutant endometrial cancer patients to the POLEmut-BLUE trial
CONDITIONS
Official Title
Refining Adjuvant Treatment IN Endometrial Cancer Based On Molecular Features
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of endometrial cancer of specified histotypes
- Full molecular classification performed as per WHO 2020 guidelines
- Hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy or sentinel node biopsy, no visible residual disease after surgery
- No distant metastases based on imaging before or after surgery
- WHO performance status 0, 1, or 2
- Expected start of adjuvant treatment within 10 weeks after surgery if applicable
- Accessible for treatment and follow-up
- Provided written informed consent for participation and tissue use
- p53 abnormal endometrial cancer for p53abn-RED trial with stage I (with invasion), II, or III, WHO performance 0-1, body weight over 30 kg, and adequate organ function
- Mismatch repair deficient endometrial cancer for MMRd-GREEN trial with specified stages, WHO performance 0-1, body weight over 30 kg, and adequate organ function
- No specific molecular profile endometrial cancer for NSMP-ORANGE trial with stage II with substantial LVSI or stage III, ER positive, WHO performance 0-1
- Pathogenic POLE mutation for POLEmut-BLUE trial with specified stage and grade combinations and ability to complete quality of life questionnaires
You will not qualify if you...
- History of another primary cancer except non-melanoma skin cancer in past 5 years
- Prior pelvic radiation
- For p53abn-RED trial: POLE mutation, mismatch repair deficiency, major surgery within 28 days before first dose, history of organ transplant, uncontrolled illness, prior PARP inhibitor treatment, active immunodeficiency, recent bleeding disorders, myelodysplastic syndrome or leukemia, prior bone marrow transplant, active infections, use of strong/moderate CYP3A inhibitors or inducers without required washout, inability to swallow oral medication, medical or psychological conditions preventing study completion
- For MMRd-GREEN trial: POLE mutation, major surgery within 28 days prior to first dose, history of organ transplant, uncontrolled illness, prior PD(L)1 inhibitor treatment, recent live vaccine, recent immunosuppressive medication except specified exceptions, active immunodeficiency, autoimmune or inflammatory disorders except specified exceptions, active infections, medical or psychological conditions preventing study completion
- For NSMP-ORANGE trial: POLE mutation, mismatch repair deficiency, p53 abnormality
- For POLEmut-BLUE trial: prior chemotherapy for endometrial cancer, isolated tumor cells in lymph nodes for main cohort
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
The POLEmut-BLUE trial: Princess Margaret Cancer Centre, University of Toronto
Toronto, Canada
Actively Recruiting
2
The POLEmut-BLUE trial: University of British Columbia
Vancouver, Canada
Actively Recruiting
3
The p53abn-RED trial: Institute Gustave Roussy
Villejuif, France
Not Yet Recruiting
4
Amsterdam University Medical Center
Amsterdam, Netherlands
Actively Recruiting
5
Amphia Ziekenhuis
Breda, Netherlands
Actively Recruiting
6
Instituut Verbeeten
Breda, Netherlands
Actively Recruiting
7
Catharina Ziekenhuis
Eindhoven, Netherlands
Actively Recruiting
8
Medisch Spectrum Twente
Enschede, Netherlands
Actively Recruiting
9
Universitair Medisch Centrum Groningen
Groningen, Netherlands
Actively Recruiting
10
The MMRd-GREEN trial: Leiden University Medical Center
Leiden, Netherlands, 2333ZA
Actively Recruiting
11
Erasmus Medical Center
Rotterdam, Netherlands
Actively Recruiting
12
Haags Medisch Centrum
The Hague, Netherlands
Actively Recruiting
13
The NSMP-ORANGE trial: Barts Health NHS Trust
London, United Kingdom
Not Yet Recruiting
14
The NSMP-ORANGE trial: Manchester Academic Health Science Centre, St Mary's Hospita
Manchester, United Kingdom
Not Yet Recruiting
Research Team
C
Carien L Creutzberg, MD PhD
CONTACT
N
Nanda Horeweg, MD PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
8
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