Adjuvant Therapy in POLE-Mutated and p53-Wildtype/NSMP Early Stage Endometrial Cancer RAINBO BLUE & TAPER
Study Details
Study Description
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 to one of two sub-studies
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EN10.A/RAINBO BLUE: POLE-mutated EC
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EN10.B/TAPER: p53 wildtype / NSMP EC
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
We are doing this study because we want 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 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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Sub-study A: RAINBO BLUE Cohort A1 Observation |
Other: Observation
Observation
|
| Experimental: Sub-Study A: RAINBO BLUE Cohort A2 Exploratory Observation or Adjuvant Radiotherapy |
Radiation: Adjuvant radiotherapy (EBRT +/- brachytherapy)
Treatment is to be delivered using 4-18 MV photons. MV, kV or CBCT imaging capabilities are required. Planning systems with capability for DICOM data transfer must be used.
Other: Observation
Observation
|
| Experimental: Sub-Study B: TAPER Observation or Vaginal Brachytherapy |
Radiation: Vaginal brachytherapy
Vaginal brachytherapy should be delivered using a vaginal cylinder, or alternatively ovoids
Other: Observation
Observation
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 the rate of distant metastasis at 3 years [3 years]
- Estimate recurrence-free survival [9 years]
- Estimate endometrial cancer-specific survival [9 years]
- Estimate overall survival [9 years]
- Describe the impact of molecular classification on patient decisional conflict [9 years]
Change in level of patient decisional conflict is defined as the change in the Decisional Conflict Scale or subscale prior to and after molecular classification
- Describe the impact of molecular classification on fear of recurrence by Fear of Recurrence Inventory [9 years]
Eligibility Criteria
Criteria
Inclusion Criteria:
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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.
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Patients must have histologically confirmed Stage I to III endometrial carcinoma which can be endometrioid, serous, clear cell, un/dedifferentiated, carcinosarcoma or mixed.
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Patients' Eastern Cooperative Group (ECOG) performance status must be 0, 1, or 2.
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Patients' age must be ≥ 18 years.
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Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements.
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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
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Patients must be accessible for treatment and follow-up. Patients enrolled on this trial must be treated and followed at the participating centre
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Protocol treatment is to begin within 10 weeks of hysterectomy/bilateral salpingo-oophorectomy
Exclusion Criteria:
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Prior Neoadjuvant chemotherapy for current endometrial cancer diagnosis.
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Prior pelvic radiation.
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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.
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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) (
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Canadian Cancer Trials Group
- Canadian Cancer Clinical Trials Network
Investigators
- Study Chair: Kathy Han, University Health Network, Princess Margaret Hospital, Toronto ON Canada
- Study Chair: Jessica McAlpine, BCCA-Vancouver Cancer Centre, Vancouver BC Canada
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EN10