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Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER
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.
Study details:
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.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: Female
Things to know
Study dates
Study start: 2022-12-19
Primary completion: 2028-12-31
Study completion finish: 2029-06-30
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT05640999
Intervention or treatment
RADIATION: Vaginal brachytherapy
RADIATION: Adjuvant radiotherapy (EBRT +/- brachytherapy)
OTHER: Observation
Conditions
- • Endometrial Cancer
Find a site
Closest Location:
Westmead Hospital
Research sites nearby
Select from list below to view details:
Westmead Hospital
Westmead, New South Wales, Australia
Monash Medical Centre
Clayton, Victoria, Australia
Frankston Hospital
Frankston, Victoria, Australia
Royal Brisbane and Womens Hospital
Herston, Not Specified, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: Sub-study A: RAINBO BLUE Cohort A1
| OTHER: Observation
|
EXPERIMENTAL: Sub-Study A: RAINBO BLUE Cohort A2 Exploratory
| RADIATION: Adjuvant radiotherapy (EBRT +/- brachytherapy)
|
EXPERIMENTAL: Sub-Study B: TAPER
| RADIATION: Vaginal brachytherapy
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Estimate the rate of pelvic recurrence at 3 years in patients who are treated with de-escalated adjuvant treatment directed by tumour molecular status | Not Specified | 3 years |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Estimate the rate of isolated vaginal recurrence at 3 years | Not Specified | 3 years |
Estimate the rate of para-aortic recurrence at 3 years | Not Specified | 3 years |
Estimate the rate of distant metastasis at 3 years | Not Specified | 3 years |
Estimate recurrence-free survival | Not Specified | 9 years |
Estimate endometrial cancer-specific survival | Not Specified | 9 years |
Estimate overall survival | Not Specified | 9 years |
Describe the impact of molecular classification on fear of recurrence by Fear of Recurrence Inventory | Not Specified | 9 years |
Frequently Asked Questions
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