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
- 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: 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.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE2
Study ID
NCT05640999
Intervention or treatment
RADIATION: Vaginal brachytherapy
RADIATION: Adjuvant radiotherapy (EBRT +/- brachytherapy)
OTHER: Observation
Conditions
- Endometrial Cancer
You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.
Research sites nearby
Closest Location:
Canberra Hospital
Select from list below to view details:
Canberra Hospital
Garran, Australia
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
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Who is running the clinical trial?
Canadian Cancer Trials Group
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
| Radiation: Adjuvant radiotherapy (EBRT +/- brachytherapy), Other: Observation |
EXPERIMENTAL: Sub-Study B: TAPER
| Radiation: Vaginal brachytherapy, Other: Observation |
What is the study measuring?
Primary Outcome
| Measure | Description | 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
| Measure | Description | 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 |
References
Clinical Trials Gov: Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPEROther trials to consider
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